Development of a Health Literacy-Based Hypertension Self-Management Education Program Using Sign Language for Deaf Individuals

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Given the high prevalence of hypertension among Deaf individuals and their vulnerability to limited health literacy, we developed Hypertension Self-Management education for the hearing-Impaired using sign LanguagE (H-SMILE) program, focusing on their health literacy. Methods Following the Analysis, Design, Development, Implementation, and Evaluation model, this methodological study included: (1) analysis through literature review, surveys, and in-depth interviews; (2) draft design of the program; and (3) program development and expert validity evaluation. A pilot test was also conducted with five Deaf individuals with hypertension to assess the program’s feasibility. Results A 12-session program was developed, covering key topics such as definition of hypertension, dietary management, weight control, exercise, blood pressure monitoring, medication adherence, smoking and alcohol use cessation, and stress management. The program includes eight pre-recorded educational video sessions produced in Korean Sign Language (KSL) and four small-group in-person sessions for review and feedback. It integrates linguistic, functional, and digital health literacy to ensure a comprehensive and accessible approach for Deaf participants. Conclusions The H-SMILE program is designed for Deaf individuals with hypertension and may be particularly beneficial for those with limited health literacy who use sign language. This program is expected to enhance health literacy, promote positive self-management behaviors, and ultimately contribute to improved health outcomes among Deaf individuals. Trial registration: This study is registered with the Clinical Research Information Service (CRIS) in South Korea under the registration number KCT0008292 (registration date: March 7, 2023). Detailed information is available on the CRIS website ( https://cris.nih.go.kr/ ). Deaf Education Health literacy Hearing impaired Hypertension Interventions Figures Figure 1 Background Deafness is a profound hearing impairment characterized by little or no hearing. It is considered an “invisible disability” as it lacks obvious physical signs but significantly affects communication, language development, cognitive function, education, employment, social relationships, and health [ 1 ]. Globally, 430 million people live with disabling hearing loss, and this number is expected to rise to nearly 700 million by 2050 [ 2 ]. The term "deaf" (lowercase d) typically refers to individuals with hearing loss from a medical standpoint, while "Deaf" (capital D) denotes individuals who use sign language as their primary form of communication and identify with a distinct cultural group [ 3 ]. Currently, over 72 million Deaf individuals worldwide use sign language [ 4 ], including approximately 12% of the 380,000 individuals with hearing impairments in South Korea [ 5 ]. Compared with the general population, Deaf individuals experience significant disparities in healthcare access and report poorer self-management and overall health outcomes [ 6 , 7 ]. Due to communication barriers, Deaf individuals struggle to access and convey health-related information effectively. Limited access to health information increases the risk of poor health outcomes [ 6 ]. Additionally, Deaf individuals often struggle to explain their symptoms and have difficulty understanding written medical instructions provided by healthcare professionals [ 8 ]. These barriers hinder Deaf individuals’ access to healthcare services, which in turn leads to inadequate health knowledge acquisition and low health literacy [ 9 ]. Health literacy is an individual’s capacity to find, comprehend, process, evaluate, and utilize health information from trusted sources [ 10 ]. A systematic review examining the health literacy levels of individuals with hearing impairments found that they generally had low health literacy [ 11 ]. Specifically, Deaf individuals who use sign language are approximately seven times more likely to have lower health literacy compared with those without hearing impairments [ 12 ]. Low health literacy among Deaf individuals contributes to limited healthcare access, unhealthy behaviors, and poor health outcomes, further widening health disparities in this population [ 13 ]. Hypertension is one of the most prevalent chronic diseases among Deaf individuals, yet their ability to manage the condition is hindered by communication barriers, low health literacy, and limited access to tailored health education. Research suggests that health literacy-based hypertension programs can improve self-management behaviors, disease knowledge, and clinical outcomes [ 14 , 15 ]. However, most existing hypertension education programs do not consider the unique needs of Deaf individuals. While some interventions, such as SMS campaigns [ 16 ] and phone-based self-care programs [ 17 ], have been attempted, they fail to accommodate the communication preferences and literacy challenges of Deaf individuals. Thus, this study aimed to develop a hypertension self-management education program specifically tailored to the needs of Deaf individuals and their health literacy levels. This paper presents the analysis, design, and development of the program using the Analysis, Design, Development, Implementation, and Evaluation (ADDIE) model, with implementation and evaluation to be reported separately. Methods Study design This methodological study applied the ADDIE model to develop a health literacy-based hypertension self-management education program for the Deaf. The ADDIE model is a cyclical process of analyzing educational needs and systematically developing a curriculum, consisting of five phases: analysis, design, development, implementation, and evaluation [ 18 ]. The specific methods used in each step are as follows. Intervention Development Step 1: Analyze The analysis phase identifies the factors and constraints affecting the program, such as participant characteristics, educational needs, required resources, and delivery systems [ 18 ]. This study conducted an analysis using a systematic literature review, a survey, and in-depth interviews. Systematic literature review The systematic literature review explored the current state of health education interventions for Deaf individuals and identified intervention strategies. Key findings include the necessity of educational interventions for managing chronic diseases among the Deaf, with strategies such as the following: (1) assisting in sign language interpretation, (2) utilizing video materials, (3) addressing health literacy, (4) utilizing peer support groups, and (5) assessing behavioral factors along with knowledge. The detailed procedures and results of this systematic review can be found in our previous article [ 19 ]. Surveys We assessed the linguistic, functional, and digital health literacy levels of 95 Deaf individuals with hypertension in a Deaf community facility in South Korea [ 20 ]. The results showed that approximately 62.1% of the participants had lower linguistic health literacy than middle school students, with a total correct answer rate of 17.9% for functional health literacy. Digital health literacy was low for both digital and critical digital literacy [ 20 ]. In-depth interviews In-depth interviews were conducted to explore the unmet needs for hypertension self-management education among Deaf individuals [ 21 ]. Ten Deaf individuals who used sign language participated in the interviews. They reported the need for education on hand pain-free exercise, the Dietary Approaches to Stop Hypertension diet, blood pressure self-monitoring methods, and hypertension complications. In addition, planning health education for the Deaf requires consideration of family support, socioeconomic status, chronic hand pain caused by sign language use, and limited health literacy, and cooperation with qualified sign language interpreters is especially important in healthcare settings [ 21 ]. Step 2: Design The design phase refines the pedagogy and builds a blueprint program based on the elements identified in the analysis phase. This includes selecting learning objectives, delivery methods, instructional strategies, and assessment tools [ 18 ]. The learning objectives of the program focused on improving hypertension self-management behaviors among Deaf participants to enhance their quality of life. The program was designed with consideration of the participants' characteristics and health literacy levels. It combined pre-recorded online video education with in-person small-group sessions. The educational videos, presented in Korean Sign Language (KSL) by a professional interpreter, were delivered via Naver Band, a widely used free mobile social media platform in South Korea. The in-person sessions, facilitated in sign language, were conducted in groups of 5–6 participants to ensure effective communication and interaction. We applied the teach-back method, which is effective in improving self-management knowledge in low health literacy populations [ 22 ]. This method involves checking comprehension by having participants explain the content in their own language. It is particularly useful for managing chronic diseases that require correct behaviors, such as exercise, diet, and medication [ 23 ]. Therefore, to ensure participants’ understanding, in-person sessions were organized after the video-based learning for feedback and evaluation. Assessment tools to assess the effectiveness of the program were reviewed. Health-related quality of life [ 24 ], hypertension knowledge [ 25 ], health literacy (linguistic [ 26 ], functional [ 27 ], digital [ 28 ]), hypertension self-management [ 29 ], hypertension medication adherence [ 30 ], depression [ 31 ], and clinical indicators (blood pressure, serum lipids) were selected as outcome variables. Table 1 provides an overview of the assessment tools used to evaluate the H-SMILE program. Data were collected at three intervals: baseline, immediately following the intervention, and 8 weeks post-intervention. The 8-week post-intervention period was considered suitable for reflecting the impact of the self-management education program on behavior change, based on a prior study, which demonstrated that it took approximately 2 months for behavior changes to become habitual [ 32 ]. Table 1 A description of the assessment tools Outcome variables Assessment tools Description Survey data Health-related quality of life Euro Quality of Life Questionnaire 5-Dimensional Classification-3L (EQ-5D-3L) Measures quality of life across five dimensions (mobility, self-management, usual activities, pain/discomfort, and anxiety/depression) with three levels each (1: no problems, 2: some problems, 3: extreme problems), plus an overall health rating on a scale of 0 to 100. Widely used with established validity [ 24 ]. Hypertension knowledge Hypertension-related knowledge 12 questions on hypertension definition, characteristics, lifestyle, and treatment. Correct answers score 1, incorrect or "don't know" score 0. Higher scores indicate better knowledge. KR-20 reliability = .87 [ 25 ]. Linguistic health literacy Korean Health Literacy Assessment Tool-2 (KHLAT-2) 66-word test; respondents choose 'know exactly' (score 1) or 'don't know exactly' (score 0). Scores range from 0 to 66; higher scores indicate better health literacy. Cronbach's alpha = .97 [ 26 ]. Functional health literacy The Short Form of the Korean Functional Health Literacy (S-KFHLT) 8 questions assessing reading comprehension (4) and math skills (4). Correct answers score 1, incorrect answers score 0. Total possible score: 8. Higher scores indicate better functional health literacy. Cronbach's alpha = .84 [ 27 ]. Digital health literacy Digital Health Technology Literacy Assessment Questionnaire (DHTL-AQ) 34 questions covering digital and critical health literacy. Correct answers score 1, incorrect answers score 0. Higher scores indicate higher digital health literacy. Total possible score: 34. Cronbach's alpha = .95 [ 28 ]. Hypertension self-management Self-management of Hypertension Inventory ver. 2 (SC-HI Korean) Measures self-management maintenance (11 questions), management, and efficacy. Responses range from 1 (never) to 4 (always). Higher scores indicate better self-management and self-efficacy. Total possible score varies. Cronbach's alpha = .83 [ 29 ]. Hypertension medication adherence Korean Version of Adherence to Refills and Medications Scale (ARMS-K) 12 questions on medication and refill adherence. Responses: 1 (never) to 4 (always). Higher scores indicate better adherence. Cronbach's alpha = .80 [ 30 ]. Depression Patient Health Questionnaire-9 (PHQ-9) 9 questions assessing depression severity. Responses: 0 (not at all) to 3 (nearly every day). Total possible score: 0–27. Higher scores indicate more severe depression. Widely used with established reliability and validity [ 31 ]. Clinical indicators Blood pressure a brachial automatic digital sphygmomanometer (Omron T5- M, Omron healthcare Co., Ltd., Japan) Measures systolic and diastolic blood pressure using a digital sphygmomanometer. Serum lipids a portable serum lipid meter (Cholestech L.D.X. Analyzer, Cholestech Corporation, Hayward, USA) Measures total cholesterol, HDL, TG, and LDL using a portable meter. Approximately 40 µL of blood collected from a fingertip capillary. Step 3: Develop In the development phase, the learning resources are created and validated [ 18 ]. This involves creating content, developing supporting media, providing writing guidance to learners and instructors, and conducting a pilot study. Based on the analysis and design phases, the research team developed a Hypertension Self-Management education for the hearing-Impaired using sign LanguagE program, referred to as the H-SMILE program. This phase included the creation of PowerPoint slides, video scripts, training booklets, guidelines for small-group sessions, and pre-training materials (e.g., instructions on how to use Naver Band and access the videos). The educational videos were produced in collaboration with the Korean Deaf Association by a professional video producer experienced in content for the Deaf and a sign language interpreter specialized in medical terminology. The H-SMILE program was validated by four experts (one cardiologist, one sign language-speaking surgeon, one nutrition expert, and one nursing professor). The validity of the program was assessed using the content validity index (CVI). The experts were asked to evaluate various aspects of the program, including its composition, content, delivery methods, and educational materials. According to Lynn’s criteria, each item was rated on a scale of 1 to 4 (1 = not relevant, 2 = somewhat relevant, 3 = quite relevant, 4 = highly relevant) [ 33 ]. The item-level CVI (I-CVI) was calculated as the number of ratings of 3 or 4 divided by the total number of experts. The overall CVI was calculated as the sum of all the I-CVIs divided by the total number of items. Expert evaluations were conducted via email, and the detailed comments provided during this process were utilized to further refine the program. This validation process ensured that the H-SMILE program met the content validity standards determined by expert consensus and feedback. As part of the validation process, modifications were made based on expert feedback to improve the program’s accessibility and practical applicability. Specifically, visual accessibility improvements were implemented by increasing the font size of text in educational video and ensuring that key visual elements, such as subtitles and takeaways, were clearly distinguishable. These adjustments aimed to enhance readability and ensure that the content was fully accessible to Deaf participants. Additionally, application of self-management techniques was strengthened by incorporating more practical implementation strategies. Experts noted that while key lifestyle changes were covered, some aspects of real-world application needed further clarification. As a result, additional case scenarios, self-monitoring checklists, and peer discussion prompts were integrated into the educational materials to facilitate engagement and reinforce self-management behaviors. A pilot test was conducted to assess the feasibility of the H-SMILE program. This was a single-arm, pre-post experimental design, involving five Deaf individuals with hypertension recruited from Deaf-related facilities. Pilot studies typically do not require formal sample size calculations, as their primary purpose is feasibility assessment rather than hypothesis testing [ 34 ]. However, to ensure a meaningful evaluation, we set our sample size at approximately 10% of the planned intervention evaluation study sample (34 participants), with an additional 10% buffer to account for potential dropout. Feasibility was assessed based on program participation rates, dropout rates, and participant satisfaction. Satisfaction was measured using a 5-point Likert scale across nine aspects: educational content; video-based education sessions; in-person sessions; delivery methods; program provider; perceived usefulness; intention to re-participate; likelihood of recommending the program to others; and overall satisfaction. Ethical approval was obtained from the Institutional Review Board of the author's affiliated institution (IRB No. 2208/004–008). Informed consent to participate was obtained from all participants prior to their inclusion in the study. Before the study began, all researchers completed training on deafness awareness, provided by the Regional Disability Healthcare Center. This study was conducted in accordance with all relevant guidelines and regulations for research involving human participants. Results H-SMILE program The H-SMILE program is a six-week intervention designed to enhance hypertension self-management among Deaf individuals by combining online video education with in-person small-group sessions. The program begins with an initial in-person session, during which participants receive a detailed explanation of the study, provide informed consent, and complete pre-intervention assessments. During this session, they are trained on how to use the Naver Band platform to access educational videos and instructed on the proper use of home blood pressure monitors for self-monitoring. Throughout the six-week intervention, participants viewed short educational videos, each lasting 8 to 13 minutes, on their smartphones. These videos cover essential topics such as the definition and risk factors of hypertension, dietary management, weight control, exercise, blood pressure monitoring, medication adherence, smoking and alcohol use cessation, and stress management. Each module included clear learning objectives, situational examples, quizzes, frequently asked questions (FAQs), and key-term reviews to facilitate comprehension and application of knowledge. The educational content was carefully designed to align with the linguistic, functional, and digital health literacy levels of Deaf individuals and incorporated practical self-management strategies tailored to their needs. Additionally, the program addressed potential barriers and facilitators that may influence self-management behaviors within the Deaf community, ensuring that the strategies were relevant and applicable to participants’ daily lives. The program materials were developed based on credible sources, including the Korean Society of Hypertension ( https://www.koreanhypertension.org/eng ), Joint National Committee 8 guidelines [ 35 ], and the Korea National Health Information Portal ( https://health.kdca.go.kr/ ). In-person sessions were conducted periodically to reinforce the content delivered through the online videos and to provide opportunities for interactive learning. Each session, lasting 30 to 60 minutes, allowed participants to review key concepts, receive feedback, and engage in practical activities such as group exercises using TheraBands. A trained researcher, supported by a sign language interpreter, facilitated the sessions using the teach-back method to ensure comprehension. This method encouraged participants to restate key concepts in their own words, thereby reinforcing their learning and enabling facilitators to identify and address any misunderstandings. Educational materials, including printed booklets, home blood pressure monitors, and healthy snacks, were provided to support participants' self-management efforts throughout the intervention. The program concluded with a final in-person session, during which participants reviewed the remaining educational videos, discuss their progress and experiences, and undergo post-intervention assessments to assess the immediate impact of the intervention. Additionally, follow-up data were collected eight weeks after the program’s completion to assess its longer-term effects. A summary of the H-SMILE program is presented in Table 2 , and an example of an online educational video is shown in Fig. 1 . Table 2 Overview of the H-SMILE program Note. H-SMILE program = Hypertension Self-Management Education for the Hearing-Impaired Using Sign LanguagE program; min = minutes. Week Session Activity description Delivery method Duration Educational resource 1 1 Complete study descriptions and consent forms Pre-intervention assessment and pre-training - Training on Naver Band and video access - Home blood pressure monitoring training In-person small-group activities with 5–6 participants (with sign language interpreters) 60 min Educational booklet for hypertension management (including self-blood pressure recording sheet), home blood pressure monitor 2 Video education 1 - Definition of hypertension Online (via Naver Band) 8 min 2 3 Video education 2 - Dietary management 8 min 4 Review and feedback on video education 1–2 In-person small-group (with interpreters) 30 min Healthy snack (soy milk and nuts) to aid blood pressure control 3 5 Video education 3 - Weight control Online (via Naver Band) 9 min 6 Video education 4 - Regular exercise 11 min 4 7 Video education 5 - Blood pressure monitoring 9 min 8 Review and feedback on video education 3–5 - TheraBand exercise In-person small-group (with interpreters) 30 min TheraBand for exercise sessions 5 9 Video education 6 - Medication adherence Online (via Naver Band) 11 min 10 Video education 7 - Smoking and alcohol use cessation 13 min 6 11 Video education 8 - Stress management 8 min 12 Review and feedback on video education 6–8 Post-intervention assessment In-person small-group (with interpreters) 60 min 14 Follow-up assessment (8 weeks later) In-person 20 min The validity of the H-SMILE program The content validity of the H-SMILE program was evaluated by four experts, who assessed the relevance and appropriateness of each item. The I-CVI ranged from 0.75 to 1.00, while the overall CVI was 0.94, indicating a high level of content validity. According to Polit and Beck (2006), when four experts are involved in content validation, an I-CVI of ≥ 0.75 and an overall CVI of ≥ 0.90 are considered appropriate [ 36 ]. Based on these criteria, the content validity of each item and the overall H-SMILE program was confirmed. Feasibility of the H-SMILE Program The feasibility of the H-SMILE program was assessed through a pilot study involving five participants with an average age of 63.20 ± 6.10 years. The sample included three men (60%) and two women, all of whom had severe hearing impairment and used sign language as their primary mode of communication. Participants had varying levels of education and were taking medication for hypertension. Additionally, each participant had other chronic conditions, including hypertension and hearing impairment. In terms of participation and dropout rates, all five participants completed the immediate post-intervention assessment. However, due to a back injury, one participant was unable to attend the 8-week follow-up, resulting in a dropout rate of 20%. Excluding this dropout, the completion rate for online video education averaged 89.25%, while the participation rate for in-person sessions was 93.75%. Participant satisfaction was assessed among the four individuals who completed the study. They evaluated nine aspects of the program: educational content; video-based education sessions; in-person sessions; delivery methods; program provider; perceived usefulness; intention to re-participate; likelihood of recommending the program to others ; and overall satisfaction with the program. All items received perfect scores of 5 out of 5. Participants reported particularly high satisfaction with the accessibility of the online videos and the structure of the in-person sessions. Engagement was strong, particularly in the in-person sessions conducted with trained researchers and sign language interpreters. The combination of online and in-person elements was well-received and considered practical for ongoing implementation. Feedback emphasized the relevance and usefulness of the educational materials. Detailed pre-, post-, and 8-week post-intervention results, including changes in hypertension knowledge, self-management behaviors, and health literacy, are provided in [Additional file 1]. Discussion The main goal of this study was to develop the H-SMILE program, a health literacy-based hypertension self-management education program designed for the Deaf. The program aimed to increase participants’ health literacy and promote healthy hypertension self-management habits, ultimately improving their quality of life. Expert evaluation confirmed the content validity of the program, and high levels of participation and satisfaction among the pilot study participants indicated that the program was feasible. In this study, the ADDIE model was used to establish intervention strategies for Deaf participants using a systematic problem-solving approach. A previous study has demonstrated that the ADDIE model is a systematic, structured, and effective approach for educational programs aimed at changing behavior in various healthcare fields [ 37 , 38 ]. Based on the strategies identified throughout the analysis, design, and development processes, the H-SMILE program provided education tailored to the health literacy levels of the Deaf. Through videos that included sign language interpretation, participants learned about hypertension self-management, including the definition of hypertension, dietary management, weight control, exercise, blood pressure monitoring, medication adherence, smoking and alcohol use cessation, and stress management. In in-person sessions, practical activities, reviews, and feedback were provided with the assistance of a sign language interpreter. The use of various learning methods, including simple and clear language, and the teach-back method was expected to increase the participants’ health literacy and improve their ability to self-manage hypertension. The application of the ADDIE model was particularly useful in this context, as it ensured a comprehensive and iterative approach to program development, allowing for continuous assessment and improvement. Health literacy was a crucial element in developing the H-SMILE program. Health literacy interventions lead to positive changes in health knowledge, behaviors, and indicators in populations at high risk of health inequities [ 39 – 41 ]. For example, Han et al. (2018) conducted a single-group pre- and post-test study of 17 Spanish-speaking Latino residents with uncontrolled hypertension in the United States to verify the acceptability and effectiveness of a health literacy-focused intervention program. The study found that 11 participants completed the program, showing improved blood pressure, numeracy, and psychological outcomes, along with high satisfaction [ 42 ]. Similarly, Delavar et al. (2020) conducted a randomized controlled trial to assess the effectiveness of health literacy-tailored self-management education among 118 older adults with hypertension in Iran and found that the intervention significantly promoted adherence to hypertension medication compared with the control group [ 43 ]. However, previous studies have often focused primarily on functional health literacy, such as reading and mathematical skills [ 44 ], and most programs lack detailed information on how health literacy is considered [ 42 , 43 ]. In contrast, we contribute methodologically by detailing and sharing the program’s development process. To ensure the program addressed participants’ actual needs, we assessed their linguistic, functional, and digital health literacy during the analysis phase [ 20 ]. These results were directly reflected in the development of customized educational materials. The H-SMILE program incorporated linguistic literacy to help Deaf individuals clearly understand health information through sign language interpretation and the use of simple language, functional literacy to enable the practical application of health management skills through hands-on activities and feedback, and digital literacy to ensure accessibility in a digital environment using videos and visual aids. Considering linguistic, functional, and digital literacy, the H-SMILE program can improve overall health literacy, enable sustainable self-management, and ultimately help eliminate health disparities among Deaf individuals. The H-SMILE program demonstrated appropriate content validity with an overall CVI of 0.94 in the expert validity assessment and achieved an 80% retention rate in the pilot study, indicating practical feasibility for both beneficiaries and providers. In addition, all participants who completed the pilot study expressed positive feedback and 100% satisfaction with all items, which was relatively higher compared with the range of satisfaction scores for hypertension self-management programs for low-income and uninsured patients, which range from 79–96% [ 45 ]. Participants particularly valued the accessibility of sign language-based online videos and the interactive nature of in-person sessions. These results suggest that combining digital and face-to-face educational approaches is effective for engaging Deaf individuals in health education. Previous studies have demonstrated that the teach-back method is particularly effective in enhancing comprehension among individuals with low health literacy [ 23 ], suggesting its potential role in supporting the observed improvements in this study. However, there is a need to increase the completion rate of online video education further. Utilizing tailored text messages or photo cards to encourage participants can be an effective strategy to boost engagement and completion rates [ 46 ]. Additionally, family members or caregivers may play a crucial role in reinforcing health education messages and supporting participants in maintaining self-management behaviors [ 21 ]. Future iterations of the program should explore these alternative delivery methods and engagement strategies to ensure greater accessibility and completion rates among diverse Deaf populations. Despite these promising results, this study has some limitations. First, the small sample size of five participants and the absence of a control group limited the generalizability of the results and the evaluation of the program's effectiveness. However, this study primarily aimed to assess the feasibility of the program for its development. Future studies should include a larger sample size and a randomized controlled trial to evaluate the effectiveness of the H-SMILE program. Second, the program’s reliance on technology for delivering online videos may not be accessible to all Deaf individuals, particularly those with limited access to digital devices or the Internet. Future studies should explore alternative delivery methods to ensure broader accessibility. Moreover, long-term follow-up studies > 2 months are required to assess the sustainability of the program’s effects on health literacy and self-management behaviors. Finally, although the program addressed linguistic, functional, and digital literacy, it did not consider other aspects of health literacy, such as critical literacy, which involves analyzing and using information to make informed health decisions [ 10 ]. Future iterations of the H-SMILE program can integrate components that enhance critical health literacy to provide a more comprehensive approach. Conclusions This study represents the first attempt to develop a hypertension self-management intervention program that considers the unique characteristics and health literacy levels of Deaf individuals. By incorporating various aspects of hypertension self-management, this program aims to address the specific needs of Deaf participants. Guided by the ADDIE model, the program was developed through a multifaceted process, including literature review, surveys, in-depth interviews, expert evaluation, and a pilot test. This systematic approach ensured the program’s scientific and practical relevance. By addressing the linguistic, functional, and digital health literacy of Deaf individuals, the H-SMILE program is expected to enhance participants’ understanding of health information and strengthen their ability to manage hypertension effectively. In the long term, the program has the potential to improve quality of life and reduce health disparities within the Deaf community. However, further research is needed to evaluate the program’s long-term efficacy. Future studies should include larger sample sizes and randomized controlled trials to confirm its effectiveness and sustainability. In conclusion, the H-SMILE program demonstrates potential for improving health literacy and self-management among Deaf individuals. Continued refinement and evaluation will help maximize its impact and accessibility. Abbreviations ADDIE: Analysis, design, development, implementation, and evaluation CRIS: Clinical research information service CVI: Content validity index H-SMILE program: Hypertension self-management education for the hearing-impaired using sign language program I-CVI: item-level content validity index Declarations Ethics approval and consent to participate This study was approved by the Institutional Review Board of Seoul National University (IRB No. 2208/004–008) and registered with the Clinical Research Information Service (CRIS No. KCT0008292). Informed consent to participate was obtained from all participants prior to their inclusion in the study. Before the study began, all researchers completed training on deafness provided by the Regional Disability Healthcare Center. This study was conducted in accordance with all relevant guidelines and regulations for research involving human participants. Consent for publication The online educational videos used in this study were pre-produced by the research team and delivered in Korean Sign Language by a medical sign language interpreter who was not a study participant. As the videos did not include any participant images, voices, or identifiable information, written consent for publication from the participants was not applicable. Availability of data and materials The datasets generated and/or analyzed during the current study are not publicly available due to privacy concerns. However, the data and materials supporting the findings of this study are available from the Seoul National University Institutional Review Board (IRB) upon reasonable request and after receiving the necessary approval. Researchers who meet the criteria for access to confidential data may contact the Seoul National University IRB via email at [email protected] . Competing interests The authors declare that they have no competing interests. Funding This study was supported by The National Research Foundation of Korea (NRF) funded by the Ministry of Science, ICT & Future Planning for their support (Grant No. NRF-2021R1F1A1052209). Author contributions Hee Jung KIM: Conceptualization, Methodology, Validation, Formal analysis, Investigation, Data curation, Writing – original draft, Writing – review & editing. Gi Won CHOI: Methodology, Validation, Investigation, Data curation, Writing – review & editing. Yujin PARK & Ha Na JEONG: Validation, Investigation, Data curation, Writing – review & editing. Sun Ju Chang: Conceptualization, Methodology, Validation, Formal analysis, Investigation, Data curation, Writing – original draft, Writing – review & editing, Project administration, Funding acquisition, Supervision. All authors approved for the final version to be published. Acknowledgements We would like to express our gratitude to the Korean Deaf Association for their assistance in the production of educational videos. We also extend our heartfelt appreciation to sign language interpreter Kyungmin Kim for her support in operating the program. References World Health Organization: World report on hearing: World Health Organization. 2021. https://www.who.int/publications/i/item/9789240020481/ . Accessed 16 Mar 2025. Haile LM, Kamenov K, Briant PS, Orji AU, Steinmetz JD, Abdoli A, Abdollahi M, Abu-Gharbieh E, Afshin A, Ahmed H. Hearing loss prevalence and years lived with disability, 1990–2019: findings from the Global Burden of Disease Study 2019. Lancet. 2021;397(10278):996–1009. 10.1016/S0140-6736(21)00516-X . Malebranche M, Morisod K, Bodenmann P. Deaf culture and health care. Can Med Assoc J. 2020;192(50):E1809–1809. 10.1503/cmaj.200772 . National Geographic Society. Sign language. Sign Language. https://education.nationalgeographic.org/resource/sign-language/ . Accessed 16 Mar 2025. Ministry of health and welfare. (2020): National survey on persons with disabilities [Korean] 2020. Korea institute for health and social affairs. https://data.kihasa.re.kr/kihasa/main.html/ . Accessed 16 Mar 2025. Rogers KD, Rowlandson A, Harkness J, Shields G, Young A. Health outcomes in Deaf signing populations: A systematic review. PLoS ONE. 2024;19(4):e0298479. 10.1371/journal.pone.0298479 . Dalal J, Cruz Reyes D, Hulo N, Martinez A, Coelho F, Keiser O, Rivas Velarde MC. Health Inequities Across D/Deaf Persons in LMIC: Examining High Rates of Potentially Preventable Loss of Sight, Cognition, Mobility, Self-Care, and Communication Across Deaf Population in Colombia. 2022. 10.2139/ssrn.4201400 Kuenburg A, Fellinger P, Fellinger J. Health Care Access Among Deaf People. J Deaf Stud Deaf Educ. 2015;21(1):1–10. 10.1093/deafed/env042 . Almusawi H, Alasim K, BinAli S, Alherz M. Disparities in health literacy during the COVID-19 pandemic between the hearing and deaf communities. Res Dev Disabil. 2021;119:104089. 10.1016/j.ridd.2021.104089 . Sørensen K, Van den Broucke S, Fullam J, Doyle G, Pelikan J, Slonska Z, Brand H, European CHLP. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012;12:1–13. 10.1186/1471-2458-12-80 . Piao Z, Lee H, Mun Y, Lee H, Han E. Exploring the health literacy status of people with hearing impairment: a systematic review. Arch Public Health. 2023;81(1):206. 10.17605/OSF.IO/V6UGW . McKee MM, Paasche-Orlow MK, Winters PC, Fiscella K, Zazove P, Sen A, Pearson T. Assessing health literacy in deaf American sign language users. J Health Commun. 2015;20(sup2):92–100. 10.1080/10810730.2015.1066468 . Wells TS, Rush SR, Nickels LD, Wu L, Bhattarai GR, Yeh CS. Limited health literacy and hearing loss among older adults. Health Lit Res Pract. 2020;4(2):e129–37. 10.3928/24748307-20200511-01 . Kim KB, Han H-R, Huh B, Nguyen T, Lee H, Kim MT. The Effect of a Community-Based Self-Help Multimodal Behavioral Intervention in Korean American Seniors With High Blood Pressure. Am J Hypertens. 2014;27(9):1199–208. 10.1093/ajh/hpu041 . Visanuyothin S, Plianbangchang S, Somrongthong R. An integrated program with home blood-pressure monitoring and village health volunteers for treating poorly controlled hypertension at the primary care level in an urban community of Thailand. Integr Blood Press Control 2018:25–35. 10.2147/IBPC.S160548 Haricharan HJ, Heap M, Hacking D, Lau YK. Health promotion via SMS improves hypertension knowledge for deaf South Africans. BMC Public Health. 2017;17:1–17. 10.1186/s12889-017-4619-7 . Park H, Jang I. The effect of telephone counseling hypertension self-management program for hypertensive patients with disabilities using the welfare center for the disabled. J Korean Appl Sci Technol. 2020;37(4):659–73. 10.12925/jkocs.2020.37.4.659 . Branch RM. Instructional design: The ADDIE approach. Volume 722. New York: Springer; 2009. Choi GW, Lee K-e, Chang SJ, Kim HJ. Health education interventions for individuals with hearing impairment: A systematic review. Patient Educ Couns. 2023;114:107830. 10.1016/j.pec.2023.107830 . Choi GW, Chang SJ, Kim HJ, Jeong HN. Understanding health literacy of deaf persons with hypertension in South Korea: A cross-sectional study. PLoS ONE. 2023;18(11):e0294765. 10.1371/journal.pone.0294765 . Jeong HN, Lee K-e, Kim HJ, Choi GW, Chang SJ. Silent struggles to self-manage high blood pressure among deaf sign language users: a qualitative study. Eur J Cardiovasc Nurs. 2024. 10.1093/eurjcn/zvad124 . Kountz DS. Strategies for improving low health literacy. Postgrad Med. 2009;121(5):171–7. 10.3810/pgm.2009.09.2065 . Dinh TTH, Bonner A, Clark R, Ramsbotham J, Hines S. The effectiveness of the teach-back method on adherence and self-management in health education for people with chronic disease: a systematic review. JBI Evid Synth. 2016;14(1):210–47. 10.11124/jbisrir-2016-2296 . Kim TH, Jo MW, Lee SI, Kim SH, Chung SM. Psychometric properties of the EQ-5D-5L in the general population of South Korea. Qual Life Res. 2013;22(8):2245–53. 10.1007/s11136-012-0331-3 . Oh JH, Park E. The impact of health literacy on self-care behaviors among hypertensive elderly. Korean J Health Educ Promot. 2017;34(1):35–45. 10.14367/kjhep.2017.34.1.35 . Kim S-S, Kim S-H, Lee S-Y. Health literacy: Development of a Korean health literacy assessment tool. Korean J Health Educ Promot. 2005;22(4):215–27. Kim SH. Validation of the short version of Korean functional health literacy test. Int J Nurs Pract. 2017;23(4):e12559. 10.1111/ijn.12559 . Yoon J, Lee M, Ahn JS, Oh D, Shin S-Y, Chang YJ, Cho J. Development and validation of digital health technology literacy assessment questionnaire. J Med Syst. 2022;46(2):13. 10.1007/s10916-022-01800-8 . Dickson VV, Lee C, Yehle KS, Abel WM, Riegel B. Psychometric Testing of the Self-care of Hypertension Inventory. J Cardiovasc Nurs. 2017;32(5):431–8. 10.1097/jcn.0000000000000364 . Kim C-J, Park E, Schlenk EA, Kim M, Kim DJ. Psychometric evaluation of a Korean version of the Adherence to Refills and Medications Scale (ARMS) in adults with type 2 diabetes. Diabetes Educ. 2016;42(2):188–98. 10.1177/0145721716632062 . Han C, Jo SA, Kwak J-H, Pae C-U, Steffens D, Jo I, Park MH. Validation of the Patient Health Questionnaire-9 Korean version in the elderly population: the Ansan Geriatric study. Compr Psychiatry. 2008;49(2):218–23. 10.1016/j.comppsych.2007.08.006 . Gardner B, Lally P, Wardle J. Making health habitual: the psychology of ‘habit-formation’and general practice. Br J Gen Pract. 2012;62(605):664–6. 10.3399/bjgp12X659466 . Lynn MR. Determination and quantification of content validity. Nurs Res. 1986;35(6):382–6. 10.1097/00006199-198611000-00017 . In J. Introduction of a pilot study. Korean J anesthesiology 2017, 70(6):601. James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507–20. 10.1001/jama.2013.284427 . Polit DF, Beck CT. The content validity index: are you sure you know what's being reported? Critique and recommendations. Res Nurs Health. 2006;29(5):489–97. 10.1002/nur.20147 . Patel SR, Margolies PJ, Covell NH, Lipscomb C, Dixon LB. Using instructional design, analyze, design, develop, implement, and evaluate, to develop e-learning modules to disseminate supported employment for community behavioral health treatment programs in New York State. Front Public Health. 2018;6:113. 10.3389/fpubh.2018.00113 . Gavarkovs AG, Blunt W, Petrella RJ. A protocol for designing online training to support the implementation of community-based interventions. Eval Program Plann. 2019;72:77–87. 10.1016/j.evalprogplan.2018.10.013 . Meherali S, Punjani NS, Mevawala A. Health literacy interventions to improve health outcomes in low-and middle-income countries. Health Lit Res Pract. 2020;4(4):e251–66. 10.3928/24748307-20201118-01 . Walters R, Leslie SJ, Polson R, Cusack T, Gorely T. Establishing the efficacy of interventions to improve health literacy and health behaviours: a systematic review. BMC Public Health. 2020;20:1–17. 10.1186/s12889-020-08991-0 . Baur C, Martinez LM, Tchangalova N, Rubin D. A review and report of community-based health literacy interventions. 2017. 10.13016/M2W66996Q Han H-R, Delva S, Greeno RV, Negoita S, Cajita M, Will W. A health literacy-focused intervention for Latinos with hypertension. Health Lit Res Pract. 2018;2(1):e21–5. 10.3928/24748307-20180108-02 . Delavar F, Pashaeypoor S, Negarandeh R. The effects of self-management education tailored to health literacy on medication adherence and blood pressure control among elderly people with primary hypertension: A randomized controlled trial. Patient Educ Couns. 2020;103(2):336–42. 10.1016/j.pec.2019.08.028 . Larsen MH, Mengshoel AM, Andersen MH, Borge CR, Ahlsen B, Dahl KG, Eik H, Holmen H, Lerdal A, Mariussen KL, et al. A bit of everything: Health literacy interventions in chronic conditions – a systematic review. Patient Educ Couns. 2022;105(10):2999–3016. 10.1016/j.pec.2022.05.008 . Warren-Findlow J, Coffman MJ, Thomas EV, Krinner LM. ECHO: a pilot health literacy intervention to improve hypertension self-care. Health Lit Res Pract. 2019;3(4):e259–67. 10.3928/24748307-20191028-01 . Teague S, Youssef GJ, Macdonald JA, Sciberras E, Shatte A, Fuller-Tyszkiewicz M, Greenwood C, McIntosh J, Olsson CA, Hutchinson D. Retention strategies in longitudinal cohort studies: a systematic review and meta-analysis. BMC Med Res Methodol. 2018;18:1–22. 10.1186/s12874-018-0586-7 . Additional Declarations No competing interests reported. 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It is considered an \u0026ldquo;invisible disability\u0026rdquo; as it lacks obvious physical signs but significantly affects communication, language development, cognitive function, education, employment, social relationships, and health [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Globally, 430\u0026nbsp;million people live with disabling hearing loss, and this number is expected to rise to nearly 700\u0026nbsp;million by 2050 [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. The term \"deaf\" (lowercase d) typically refers to individuals with hearing loss from a medical standpoint, while \"Deaf\" (capital D) denotes individuals who use sign language as their primary form of communication and identify with a distinct cultural group [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Currently, over 72\u0026nbsp;million Deaf individuals worldwide use sign language [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e], including approximately 12% of the 380,000 individuals with hearing impairments in South Korea [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eCompared with the general population, Deaf individuals experience significant disparities in healthcare access and report poorer self-management and overall health outcomes [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Due to communication barriers, Deaf individuals struggle to access and convey health-related information effectively. Limited access to health information increases the risk of poor health outcomes [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Additionally, Deaf individuals often struggle to explain their symptoms and have difficulty understanding written medical instructions provided by healthcare professionals [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. These barriers hinder Deaf individuals\u0026rsquo; access to healthcare services, which in turn leads to inadequate health knowledge acquisition and low health literacy [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Health literacy is an individual\u0026rsquo;s capacity to find, comprehend, process, evaluate, and utilize health information from trusted sources [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. A systematic review examining the health literacy levels of individuals with hearing impairments found that they generally had low health literacy [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Specifically, Deaf individuals who use sign language are approximately seven times more likely to have lower health literacy compared with those without hearing impairments [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Low health literacy among Deaf individuals contributes to limited healthcare access, unhealthy behaviors, and poor health outcomes, further widening health disparities in this population [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eHypertension is one of the most prevalent chronic diseases among Deaf individuals, yet their ability to manage the condition is hindered by communication barriers, low health literacy, and limited access to tailored health education. Research suggests that health literacy-based hypertension programs can improve self-management behaviors, disease knowledge, and clinical outcomes [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. However, most existing hypertension education programs do not consider the unique needs of Deaf individuals. While some interventions, such as SMS campaigns [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e] and phone-based self-care programs [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], have been attempted, they fail to accommodate the communication preferences and literacy challenges of Deaf individuals. Thus, this study aimed to develop a hypertension self-management education program specifically tailored to the needs of Deaf individuals and their health literacy levels. This paper presents the analysis, design, and development of the program using the Analysis, Design, Development, Implementation, and Evaluation (ADDIE) model, with implementation and evaluation to be reported separately.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003eThis methodological study applied the ADDIE model to develop a health literacy-based hypertension self-management education program for the Deaf. The ADDIE model is a cyclical process of analyzing educational needs and systematically developing a curriculum, consisting of five phases: analysis, design, development, implementation, and evaluation [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. The specific methods used in each step are as follows.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eIntervention Development\u003c/h3\u003e\n\u003cp\u003eStep 1: Analyze\u003c/p\u003e \u003cp\u003eThe analysis phase identifies the factors and constraints affecting the program, such as participant characteristics, educational needs, required resources, and delivery systems [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. This study conducted an analysis using a systematic literature review, a survey, and in-depth interviews.\u003c/p\u003e\n\u003ch3\u003eSystematic literature review\u003c/h3\u003e\n\u003cp\u003eThe systematic literature review explored the current state of health education interventions for Deaf individuals and identified intervention strategies. Key findings include the necessity of educational interventions for managing chronic diseases among the Deaf, with strategies such as the following: (1) assisting in sign language interpretation, (2) utilizing video materials, (3) addressing health literacy, (4) utilizing peer support groups, and (5) assessing behavioral factors along with knowledge. The detailed procedures and results of this systematic review can be found in our previous article [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e].\u003c/p\u003e\n\u003ch3\u003eSurveys\u003c/h3\u003e\n\u003cp\u003eWe assessed the linguistic, functional, and digital health literacy levels of 95 Deaf individuals with hypertension in a Deaf community facility in South Korea [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. The results showed that approximately 62.1% of the participants had lower linguistic health literacy than middle school students, with a total correct answer rate of 17.9% for functional health literacy. Digital health literacy was low for both digital and critical digital literacy [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e\n\u003ch3\u003eIn-depth interviews\u003c/h3\u003e\n\u003cp\u003eIn-depth interviews were conducted to explore the unmet needs for hypertension self-management education among Deaf individuals [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Ten Deaf individuals who used sign language participated in the interviews. They reported the need for education on hand pain-free exercise, the Dietary Approaches to Stop Hypertension diet, blood pressure self-monitoring methods, and hypertension complications. In addition, planning health education for the Deaf requires consideration of family support, socioeconomic status, chronic hand pain caused by sign language use, and limited health literacy, and cooperation with qualified sign language interpreters is especially important in healthcare settings [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eStep 2: Design\u003c/p\u003e \u003cp\u003eThe design phase refines the pedagogy and builds a blueprint program based on the elements identified in the analysis phase. This includes selecting learning objectives, delivery methods, instructional strategies, and assessment tools [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e The learning objectives of the program focused on improving hypertension self-management behaviors among Deaf participants to enhance their quality of life. The program was designed with consideration of the participants' characteristics and health literacy levels. It combined pre-recorded online video education with in-person small-group sessions. The educational videos, presented in Korean Sign Language (KSL) by a professional interpreter, were delivered via Naver Band, a widely used free mobile social media platform in South Korea. The in-person sessions, facilitated in sign language, were conducted in groups of 5\u0026ndash;6 participants to ensure effective communication and interaction. We applied the teach-back method, which is effective in improving self-management knowledge in low health literacy populations [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. This method involves checking comprehension by having participants explain the content in their own language. It is particularly useful for managing chronic diseases that require correct behaviors, such as exercise, diet, and medication [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Therefore, to ensure participants\u0026rsquo; understanding, in-person sessions were organized after the video-based learning for feedback and evaluation. Assessment tools to assess the effectiveness of the program were reviewed. Health-related quality of life [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e], hypertension knowledge [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e], health literacy (linguistic [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e], functional [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e], digital [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]), hypertension self-management [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e], hypertension medication adherence [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e], depression [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e], and clinical indicators (blood pressure, serum lipids) were selected as outcome variables. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e provides an overview of the assessment tools used to evaluate the H-SMILE program. Data were collected at three intervals: baseline, immediately following the intervention, and 8 weeks post-intervention. The 8-week post-intervention period was considered suitable for reflecting the impact of the self-management education program on behavior change, based on a prior study, which demonstrated that it took approximately 2 months for behavior changes to become habitual [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eA description of the assessment tools\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutcome variables\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAssessment tools\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDescription\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurvey data\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHealth-related quality of life\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEuro Quality of Life Questionnaire 5-Dimensional Classification-3L (EQ-5D-3L)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMeasures quality of life across five dimensions (mobility, self-management, usual activities, pain/discomfort, and anxiety/depression) with three levels each (1: no problems, 2: some problems, 3: extreme problems), plus an overall health rating on a scale of 0 to 100. Widely used with established validity [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e].\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension knowledge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHypertension-related knowledge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 questions on hypertension definition, characteristics, lifestyle, and treatment. Correct answers score 1, incorrect or \"don't know\" score 0. Higher scores indicate better knowledge. KR-20 reliability\u0026thinsp;=\u0026thinsp;.87 [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e].\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLinguistic health literacy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eKorean Health Literacy Assessment Tool-2 (KHLAT-2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e66-word test; respondents choose 'know exactly' (score 1) or 'don't know exactly' (score 0). Scores range from 0 to 66; higher scores indicate better health literacy. Cronbach's alpha\u0026thinsp;=\u0026thinsp;.97 [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFunctional health literacy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eThe Short Form of the Korean Functional Health Literacy (S-KFHLT)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 questions assessing reading comprehension (4) and math skills (4). Correct answers score 1, incorrect answers score 0. Total possible score: 8. Higher scores indicate better functional health literacy. Cronbach's alpha\u0026thinsp;=\u0026thinsp;.84 [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDigital health literacy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDigital Health Technology Literacy Assessment Questionnaire (DHTL-AQ)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e34 questions covering digital and critical health literacy. Correct answers score 1, incorrect answers score 0. Higher scores indicate higher digital health literacy. Total possible score: 34. Cronbach's alpha\u0026thinsp;=\u0026thinsp;.95 [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e].\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension self-management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSelf-management of Hypertension Inventory ver. 2 (SC-HI Korean)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMeasures self-management maintenance (11 questions), management, and efficacy. Responses range from 1 (never) to 4 (always). Higher scores indicate better self-management and self-efficacy. Total possible score varies. Cronbach's alpha\u0026thinsp;=\u0026thinsp;.83 [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e].\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension medication adherence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eKorean Version of Adherence to Refills and Medications Scale (ARMS-K)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 questions on medication and refill adherence. Responses: 1 (never) to 4 (always). Higher scores indicate better adherence. Cronbach's alpha\u0026thinsp;=\u0026thinsp;.80 [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e].\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDepression\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePatient Health Questionnaire-9 (PHQ-9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 questions assessing depression severity. Responses: 0 (not at all) to 3 (nearly every day). Total possible score: 0\u0026ndash;27. Higher scores indicate more severe depression. Widely used with established reliability and validity [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e].\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eClinical indicators\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBlood pressure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ea brachial automatic digital sphygmomanometer (Omron T5- M, Omron healthcare Co., Ltd., Japan)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMeasures systolic and diastolic blood pressure using a digital sphygmomanometer.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSerum lipids\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ea portable serum lipid meter (Cholestech L.D.X. Analyzer, Cholestech Corporation, Hayward, USA)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMeasures total cholesterol, HDL, TG, and LDL using a portable meter. Approximately 40 \u0026micro;L of blood collected from a fingertip capillary.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eStep 3: Develop\u003c/p\u003e \u003cp\u003eIn the development phase, the learning resources are created and validated [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. This involves creating content, developing supporting media, providing writing guidance to learners and instructors, and conducting a pilot study.\u003c/p\u003e \u003cp\u003eBased on the analysis and design phases, the research team developed a Hypertension Self-Management education for the hearing-Impaired using sign LanguagE program, referred to as the H-SMILE program. This phase included the creation of PowerPoint slides, video scripts, training booklets, guidelines for small-group sessions, and pre-training materials (e.g., instructions on how to use Naver Band and access the videos). The educational videos were produced in collaboration with the Korean Deaf Association by a professional video producer experienced in content for the Deaf and a sign language interpreter specialized in medical terminology.\u003c/p\u003e \u003cp\u003eThe H-SMILE program was validated by four experts (one cardiologist, one sign language-speaking surgeon, one nutrition expert, and one nursing professor). The validity of the program was assessed using the content validity index (CVI). The experts were asked to evaluate various aspects of the program, including its composition, content, delivery methods, and educational materials. According to Lynn\u0026rsquo;s criteria, each item was rated on a scale of 1 to 4 (1\u0026thinsp;=\u0026thinsp;not relevant, 2\u0026thinsp;=\u0026thinsp;somewhat relevant, 3\u0026thinsp;=\u0026thinsp;quite relevant, 4\u0026thinsp;=\u0026thinsp;highly relevant) [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. The item-level CVI (I-CVI) was calculated as the number of ratings of 3 or 4 divided by the total number of experts. The overall CVI was calculated as the sum of all the I-CVIs divided by the total number of items. Expert evaluations were conducted via email, and the detailed comments provided during this process were utilized to further refine the program. This validation process ensured that the H-SMILE program met the content validity standards determined by expert consensus and feedback. As part of the validation process, modifications were made based on expert feedback to improve the program\u0026rsquo;s accessibility and practical applicability. Specifically, visual accessibility improvements were implemented by increasing the font size of text in educational video and ensuring that key visual elements, such as subtitles and takeaways, were clearly distinguishable. These adjustments aimed to enhance readability and ensure that the content was fully accessible to Deaf participants. Additionally, application of self-management techniques was strengthened by incorporating more practical implementation strategies. Experts noted that while key lifestyle changes were covered, some aspects of real-world application needed further clarification. As a result, additional case scenarios, self-monitoring checklists, and peer discussion prompts were integrated into the educational materials to facilitate engagement and reinforce self-management behaviors.\u003c/p\u003e \u003cp\u003eA pilot test was conducted to assess the feasibility of the H-SMILE program. This was a single-arm, pre-post experimental design, involving five Deaf individuals with hypertension recruited from Deaf-related facilities. Pilot studies typically do not require formal sample size calculations, as their primary purpose is feasibility assessment rather than hypothesis testing [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. However, to ensure a meaningful evaluation, we set our sample size at approximately 10% of the planned intervention evaluation study sample (34 participants), with an additional 10% buffer to account for potential dropout. Feasibility was assessed based on program participation rates, dropout rates, and participant satisfaction. Satisfaction was measured using a 5-point Likert scale across nine aspects: educational content; video-based education sessions; in-person sessions; delivery methods; program provider; perceived usefulness; intention to re-participate; likelihood of recommending the program to others; and overall satisfaction. Ethical approval was obtained from the Institutional Review Board of the author's affiliated institution (IRB No. 2208/004\u0026ndash;008). Informed consent to participate was obtained from all participants prior to their inclusion in the study. Before the study began, all researchers completed training on deafness awareness, provided by the Regional Disability Healthcare Center. This study was conducted in accordance with all relevant guidelines and regulations for research involving human participants.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003e\u003cb\u003eH-SMILE program\u003c/b\u003e\u003c/h2\u003e \u003cp\u003eThe H-SMILE program is a six-week intervention designed to enhance hypertension self-management among Deaf individuals by combining online video education with in-person small-group sessions. The program begins with an initial in-person session, during which participants receive a detailed explanation of the study, provide informed consent, and complete pre-intervention assessments. During this session, they are trained on how to use the Naver Band platform to access educational videos and instructed on the proper use of home blood pressure monitors for self-monitoring.\u003c/p\u003e \u003cp\u003eThroughout the six-week intervention, participants viewed short educational videos, each lasting 8 to 13 minutes, on their smartphones. These videos cover essential topics such as the definition and risk factors of hypertension, dietary management, weight control, exercise, blood pressure monitoring, medication adherence, smoking and alcohol use cessation, and stress management. Each module included clear learning objectives, situational examples, quizzes, frequently asked questions (FAQs), and key-term reviews to facilitate comprehension and application of knowledge. The educational content was carefully designed to align with the linguistic, functional, and digital health literacy levels of Deaf individuals and incorporated practical self-management strategies tailored to their needs. Additionally, the program addressed potential barriers and facilitators that may influence self-management behaviors within the Deaf community, ensuring that the strategies were relevant and applicable to participants\u0026rsquo; daily lives. The program materials were developed based on credible sources, including the Korean Society of Hypertension (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.koreanhypertension.org/eng\u003c/span\u003e\u003cspan address=\"https://www.koreanhypertension.org/eng\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e), Joint National Committee 8 guidelines [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e], and the Korea National Health Information Portal (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://health.kdca.go.kr/\u003c/span\u003e\u003cspan address=\"https://health.kdca.go.kr/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn-person sessions were conducted periodically to reinforce the content delivered through the online videos and to provide opportunities for interactive learning. Each session, lasting 30 to 60 minutes, allowed participants to review key concepts, receive feedback, and engage in practical activities such as group exercises using TheraBands. A trained researcher, supported by a sign language interpreter, facilitated the sessions using the teach-back method to ensure comprehension. This method encouraged participants to restate key concepts in their own words, thereby reinforcing their learning and enabling facilitators to identify and address any misunderstandings. Educational materials, including printed booklets, home blood pressure monitors, and healthy snacks, were provided to support participants' self-management efforts throughout the intervention.\u003c/p\u003e \u003cp\u003eThe program concluded with a final in-person session, during which participants reviewed the remaining educational videos, discuss their progress and experiences, and undergo post-intervention assessments to assess the immediate impact of the intervention. Additionally, follow-up data were collected eight weeks after the program\u0026rsquo;s completion to assess its longer-term effects. A summary of the H-SMILE program is presented in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, and an example of an online educational video is shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOverview of the H-SMILE program Note. H-SMILE program\u0026thinsp;=\u0026thinsp;Hypertension Self-Management Education for the Hearing-Impaired Using Sign LanguagE program; min\u0026thinsp;=\u0026thinsp;minutes.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eWeek\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSession\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eActivity description\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eDelivery method\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eDuration\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eEducational resource\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eComplete study descriptions and consent forms\u003c/p\u003e \u003cp\u003ePre-intervention assessment and pre-training\u003c/p\u003e \u003cp\u003e- Training on Naver Band and video access\u003c/p\u003e \u003cp\u003e- Home blood pressure monitoring training\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eIn-person small-group activities with 5\u0026ndash;6 participants\u003c/p\u003e \u003cp\u003e(with sign language interpreters)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e60 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eEducational booklet for hypertension management (including self-blood pressure recording sheet), home blood pressure monitor\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eVideo education 1\u003c/p\u003e \u003cp\u003e- Definition of hypertension\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eOnline (via Naver Band)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e8 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eVideo education 2\u003c/p\u003e \u003cp\u003e- Dietary management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e8 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReview and feedback on video education 1\u0026ndash;2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eIn-person small-group\u003c/p\u003e \u003cp\u003e(with interpreters)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e30 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eHealthy snack (soy milk and nuts) to aid blood pressure control\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eVideo education 3\u003c/p\u003e \u003cp\u003e- Weight control\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eOnline (via Naver Band)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e9 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eVideo education 4\u003c/p\u003e \u003cp\u003e- Regular exercise\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eVideo education 5\u003c/p\u003e \u003cp\u003e- Blood pressure monitoring\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e9 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReview and feedback on video education 3\u0026ndash;5\u003c/p\u003e \u003cp\u003e- TheraBand exercise\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eIn-person small-group\u003c/p\u003e \u003cp\u003e(with interpreters)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e30 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eTheraBand for exercise sessions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eVideo education 6\u003c/p\u003e \u003cp\u003e- Medication adherence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eOnline (via Naver Band)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eVideo education 7\u003c/p\u003e \u003cp\u003e- Smoking and alcohol use cessation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eVideo education 8\u003c/p\u003e \u003cp\u003e- Stress management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e8 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReview and feedback on video education 6\u0026ndash;8\u003c/p\u003e \u003cp\u003ePost-intervention assessment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eIn-person small-group\u003c/p\u003e \u003cp\u003e(with interpreters)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e60 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFollow-up assessment (8 weeks later)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eIn-person\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e20 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/br\u003e\n\u003cdiv class=\"Heading\"\u003e\u003cb\u003eThe validity of the H-SMILE program\u003c/b\u003e\u003c/div\u003e \u003cp\u003eThe content validity of the H-SMILE program was evaluated by four experts, who assessed the relevance and appropriateness of each item. The I-CVI ranged from 0.75 to 1.00, while the overall CVI was 0.94, indicating a high level of content validity. According to Polit and Beck (2006), when four experts are involved in content validation, an I-CVI of \u0026ge;\u0026thinsp;0.75 and an overall CVI of \u0026ge;\u0026thinsp;0.90 are considered appropriate [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. Based on these criteria, the content validity of each item and the overall H-SMILE program was confirmed.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003e\u003cb\u003eFeasibility of the H-SMILE Program\u003c/b\u003e\u003c/h2\u003e \u003cp\u003eThe feasibility of the H-SMILE program was assessed through a pilot study involving five participants with an average age of 63.20\u0026thinsp;\u0026plusmn;\u0026thinsp;6.10 years. The sample included three men (60%) and two women, all of whom had severe hearing impairment and used sign language as their primary mode of communication. Participants had varying levels of education and were taking medication for hypertension. Additionally, each participant had other chronic conditions, including hypertension and hearing impairment.\u003c/p\u003e \u003cp\u003eIn terms of participation and dropout rates, all five participants completed the immediate post-intervention assessment. However, due to a back injury, one participant was unable to attend the 8-week follow-up, resulting in a dropout rate of 20%. Excluding this dropout, the completion rate for online video education averaged 89.25%, while the participation rate for in-person sessions was 93.75%.\u003c/p\u003e \u003cp\u003eParticipant satisfaction was assessed among the four individuals who completed the study. They evaluated nine aspects of the program: educational content; video-based education sessions; in-person sessions; delivery methods; program provider; perceived usefulness; intention to re-participate; likelihood of recommending the program to others ; and overall satisfaction with the program. All items received perfect scores of 5 out of 5. Participants reported particularly high satisfaction with the accessibility of the online videos and the structure of the in-person sessions. Engagement was strong, particularly in the in-person sessions conducted with trained researchers and sign language interpreters. The combination of online and in-person elements was well-received and considered practical for ongoing implementation. Feedback emphasized the relevance and usefulness of the educational materials. Detailed pre-, post-, and 8-week post-intervention results, including changes in hypertension knowledge, self-management behaviors, and health literacy, are provided in [Additional file 1].\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe main goal of this study was to develop the H-SMILE program, a health literacy-based hypertension self-management education program designed for the Deaf. The program aimed to increase participants\u0026rsquo; health literacy and promote healthy hypertension self-management habits, ultimately improving their quality of life. Expert evaluation confirmed the content validity of the program, and high levels of participation and satisfaction among the pilot study participants indicated that the program was feasible.\u003c/p\u003e \u003cp\u003e In this study, the ADDIE model was used to establish intervention strategies for Deaf participants using a systematic problem-solving approach. A previous study has demonstrated that the ADDIE model is a systematic, structured, and effective approach for educational programs aimed at changing behavior in various healthcare fields [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e, \u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e]. Based on the strategies identified throughout the analysis, design, and development processes, the H-SMILE program provided education tailored to the health literacy levels of the Deaf. Through videos that included sign language interpretation, participants learned about hypertension self-management, including the definition of hypertension, dietary management, weight control, exercise, blood pressure monitoring, medication adherence, smoking and alcohol use cessation, and stress management. In in-person sessions, practical activities, reviews, and feedback were provided with the assistance of a sign language interpreter. The use of various learning methods, including simple and clear language, and the teach-back method was expected to increase the participants\u0026rsquo; health literacy and improve their ability to self-manage hypertension. The application of the ADDIE model was particularly useful in this context, as it ensured a comprehensive and iterative approach to program development, allowing for continuous assessment and improvement.\u003c/p\u003e \u003cp\u003eHealth literacy was a crucial element in developing the H-SMILE program. Health literacy interventions lead to positive changes in health knowledge, behaviors, and indicators in populations at high risk of health inequities [\u003cspan additionalcitationids=\"CR40\" citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]. For example, Han et al. (2018) conducted a single-group pre- and post-test study of 17 Spanish-speaking Latino residents with uncontrolled hypertension in the United States to verify the acceptability and effectiveness of a health literacy-focused intervention program. The study found that 11 participants completed the program, showing improved blood pressure, numeracy, and psychological outcomes, along with high satisfaction [\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e]. Similarly, Delavar et al. (2020) conducted a randomized controlled trial to assess the effectiveness of health literacy-tailored self-management education among 118 older adults with hypertension in Iran and found that the intervention significantly promoted adherence to hypertension medication compared with the control group [\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e]. However, previous studies have often focused primarily on functional health literacy, such as reading and mathematical skills [\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e], and most programs lack detailed information on how health literacy is considered [\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e, \u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e]. In contrast, we contribute methodologically by detailing and sharing the program\u0026rsquo;s development process. To ensure the program addressed participants\u0026rsquo; actual needs, we assessed their linguistic, functional, and digital health literacy during the analysis phase [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. These results were directly reflected in the development of customized educational materials. The H-SMILE program incorporated linguistic literacy to help Deaf individuals clearly understand health information through sign language interpretation and the use of simple language, functional literacy to enable the practical application of health management skills through hands-on activities and feedback, and digital literacy to ensure accessibility in a digital environment using videos and visual aids. Considering linguistic, functional, and digital literacy, the H-SMILE program can improve overall health literacy, enable sustainable self-management, and ultimately help eliminate health disparities among Deaf individuals.\u003c/p\u003e \u003cp\u003eThe H-SMILE program demonstrated appropriate content validity with an overall CVI of 0.94 in the expert validity assessment and achieved an 80% retention rate in the pilot study, indicating practical feasibility for both beneficiaries and providers. In addition, all participants who completed the pilot study expressed positive feedback and 100% satisfaction with all items, which was relatively higher compared with the range of satisfaction scores for hypertension self-management programs for low-income and uninsured patients, which range from 79\u0026ndash;96% [\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e]. Participants particularly valued the accessibility of sign language-based online videos and the interactive nature of in-person sessions. These results suggest that combining digital and face-to-face educational approaches is effective for engaging Deaf individuals in health education. Previous studies have demonstrated that the teach-back method is particularly effective in enhancing comprehension among individuals with low health literacy [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e], suggesting its potential role in supporting the observed improvements in this study. However, there is a need to increase the completion rate of online video education further. Utilizing tailored text messages or photo cards to encourage participants can be an effective strategy to boost engagement and completion rates [\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e]. Additionally, family members or caregivers may play a crucial role in reinforcing health education messages and supporting participants in maintaining self-management behaviors [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Future iterations of the program should explore these alternative delivery methods and engagement strategies to ensure greater accessibility and completion rates among diverse Deaf populations.\u003c/p\u003e \u003cp\u003eDespite these promising results, this study has some limitations. First, the small sample size of five participants and the absence of a control group limited the generalizability of the results and the evaluation of the program's effectiveness. However, this study primarily aimed to assess the feasibility of the program for its development. Future studies should include a larger sample size and a randomized controlled trial to evaluate the effectiveness of the H-SMILE program. Second, the program\u0026rsquo;s reliance on technology for delivering online videos may not be accessible to all Deaf individuals, particularly those with limited access to digital devices or the Internet. Future studies should explore alternative delivery methods to ensure broader accessibility. Moreover, long-term follow-up studies\u0026thinsp;\u0026gt;\u0026thinsp;2 months are required to assess the sustainability of the program\u0026rsquo;s effects on health literacy and self-management behaviors. Finally, although the program addressed linguistic, functional, and digital literacy, it did not consider other aspects of health literacy, such as critical literacy, which involves analyzing and using information to make informed health decisions [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Future iterations of the H-SMILE program can integrate components that enhance critical health literacy to provide a more comprehensive approach.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThis study represents the first attempt to develop a hypertension self-management intervention program that considers the unique characteristics and health literacy levels of Deaf individuals. By incorporating various aspects of hypertension self-management, this program aims to address the specific needs of Deaf participants. Guided by the ADDIE model, the program was developed through a multifaceted process, including literature review, surveys, in-depth interviews, expert evaluation, and a pilot test. This systematic approach ensured the program\u0026rsquo;s scientific and practical relevance. By addressing the linguistic, functional, and digital health literacy of Deaf individuals, the H-SMILE program is expected to enhance participants\u0026rsquo; understanding of health information and strengthen their ability to manage hypertension effectively. In the long term, the program has the potential to improve quality of life and reduce health disparities within the Deaf community. However, further research is needed to evaluate the program\u0026rsquo;s long-term efficacy. Future studies should include larger sample sizes and randomized controlled trials to confirm its effectiveness and sustainability. In conclusion, the H-SMILE program demonstrates potential for improving health literacy and self-management among Deaf individuals. Continued refinement and evaluation will help maximize its impact and accessibility.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eADDIE:\u003c/em\u003e\u003c/strong\u003e Analysis, design, development, implementation, and evaluation\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCRIS:\u003c/em\u003e\u003c/strong\u003e Clinical research information service\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCVI:\u003c/em\u003e\u003c/strong\u003e Content validity index\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eH-SMILE program:\u003c/em\u003e\u003c/strong\u003e Hypertension self-management education for the hearing-impaired using sign language program\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eI-CVI:\u003c/em\u003e\u003c/strong\u003e item-level content validity index\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Institutional Review Board of Seoul National University (IRB No. 2208/004\u0026ndash;008) and registered with the Clinical Research Information Service (CRIS No. KCT0008292). Informed consent to participate was obtained from all participants prior to their inclusion in the study. Before the study began, all researchers completed training on deafness provided by the Regional Disability Healthcare Center. This study was conducted in accordance with all relevant guidelines and regulations for research involving human participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe online educational videos used in this study were pre-produced by the research team and delivered in Korean Sign Language by a medical sign language interpreter who was not a study participant. As the videos did not include any participant images, voices, or identifiable information, written consent for publication from the participants was not applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and/or analyzed during the current study are not publicly available due to privacy concerns. However, the data and materials supporting the findings of this study are available from the Seoul National University Institutional Review Board (IRB) upon reasonable request and after receiving the necessary approval. Researchers who meet the criteria for access to confidential data may contact the Seoul National University IRB via email at [email protected].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCompeting interests\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was supported by The National Research Foundation of Korea (NRF) funded by the Ministry of Science, ICT \u0026amp; Future Planning for their support (Grant No. NRF-2021R1F1A1052209).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthor contributions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHee Jung KIM: Conceptualization, Methodology, Validation, Formal analysis, Investigation, Data curation, Writing \u0026ndash; original draft, Writing \u0026ndash; review \u0026amp; editing. Gi Won CHOI: Methodology, Validation, Investigation, Data curation, Writing \u0026ndash; review \u0026amp; editing. Yujin PARK \u0026amp; Ha Na JEONG: Validation, Investigation, Data curation, Writing \u0026ndash; review \u0026amp; editing. Sun Ju Chang: Conceptualization, Methodology, Validation, Formal analysis, Investigation, Data curation, Writing \u0026ndash; original draft, Writing \u0026ndash; review \u0026amp; editing, Project administration, Funding acquisition, Supervision. All authors approved for the final version to be published.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgements\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to express our gratitude to the Korean Deaf Association for their assistance in the production of educational videos. We also extend our heartfelt appreciation to sign language interpreter Kyungmin Kim for her support in operating the program.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eWorld Health Organization: World report on hearing: World Health Organization. 2021. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.who.int/publications/i/item/9789240020481/\u003c/span\u003e\u003cspan address=\"https://www.who.int/publications/i/item/9789240020481/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 16 Mar 2025.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHaile LM, Kamenov K, Briant PS, Orji AU, Steinmetz JD, Abdoli A, Abdollahi M, Abu-Gharbieh E, Afshin A, Ahmed H. Hearing loss prevalence and years lived with disability, 1990\u0026ndash;2019: findings from the Global Burden of Disease Study 2019. Lancet. 2021;397(10278):996\u0026ndash;1009. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/S0140-6736(21)00516-X\u003c/span\u003e\u003cspan address=\"10.1016/S0140-6736(21)00516-X\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMalebranche M, Morisod K, Bodenmann P. Deaf culture and health care. Can Med Assoc J. 2020;192(50):E1809\u0026ndash;1809. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1503/cmaj.200772\u003c/span\u003e\u003cspan address=\"10.1503/cmaj.200772\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNational Geographic Society. Sign language. Sign Language. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://education.nationalgeographic.org/resource/sign-language/\u003c/span\u003e\u003cspan address=\"https://education.nationalgeographic.org/resource/sign-language/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 16 Mar 2025.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMinistry of health and welfare. (2020): National survey on persons with disabilities [Korean] 2020. Korea institute for health and social affairs. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://data.kihasa.re.kr/kihasa/main.html/\u003c/span\u003e\u003cspan address=\"https://data.kihasa.re.kr/kihasa/main.html/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 16 Mar 2025.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRogers KD, Rowlandson A, Harkness J, Shields G, Young A. Health outcomes in Deaf signing populations: A systematic review. PLoS ONE. 2024;19(4):e0298479. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1371/journal.pone.0298479\u003c/span\u003e\u003cspan address=\"10.1371/journal.pone.0298479\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDalal J, Cruz Reyes D, Hulo N, Martinez A, Coelho F, Keiser O, Rivas Velarde MC. Health Inequities Across D/Deaf Persons in LMIC: Examining High Rates of Potentially Preventable Loss of Sight, Cognition, Mobility, Self-Care, and Communication Across Deaf Population in Colombia. 2022. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2139/ssrn.4201400\u003c/span\u003e\u003cspan address=\"10.2139/ssrn.4201400\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKuenburg A, Fellinger P, Fellinger J. Health Care Access Among Deaf People. J Deaf Stud Deaf Educ. 2015;21(1):1\u0026ndash;10. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1093/deafed/env042\u003c/span\u003e\u003cspan address=\"10.1093/deafed/env042\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAlmusawi H, Alasim K, BinAli S, Alherz M. Disparities in health literacy during the COVID-19 pandemic between the hearing and deaf communities. Res Dev Disabil. 2021;119:104089. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.ridd.2021.104089\u003c/span\u003e\u003cspan address=\"10.1016/j.ridd.2021.104089\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eS\u0026oslash;rensen K, Van den Broucke S, Fullam J, Doyle G, Pelikan J, Slonska Z, Brand H, European CHLP. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012;12:1\u0026ndash;13. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1186/1471-2458-12-80\u003c/span\u003e\u003cspan address=\"10.1186/1471-2458-12-80\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePiao Z, Lee H, Mun Y, Lee H, Han E. Exploring the health literacy status of people with hearing impairment: a systematic review. Arch Public Health. 2023;81(1):206. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.17605/OSF.IO/V6UGW\u003c/span\u003e\u003cspan address=\"10.17605/OSF.IO/V6UGW\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMcKee MM, Paasche-Orlow MK, Winters PC, Fiscella K, Zazove P, Sen A, Pearson T. Assessing health literacy in deaf American sign language users. J Health Commun. 2015;20(sup2):92\u0026ndash;100. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1080/10810730.2015.1066468\u003c/span\u003e\u003cspan address=\"10.1080/10810730.2015.1066468\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWells TS, Rush SR, Nickels LD, Wu L, Bhattarai GR, Yeh CS. Limited health literacy and hearing loss among older adults. Health Lit Res Pract. 2020;4(2):e129\u0026ndash;37. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3928/24748307-20200511-01\u003c/span\u003e\u003cspan address=\"10.3928/24748307-20200511-01\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKim KB, Han H-R, Huh B, Nguyen T, Lee H, Kim MT. The Effect of a Community-Based Self-Help Multimodal Behavioral Intervention in Korean American Seniors With High Blood Pressure. Am J Hypertens. 2014;27(9):1199\u0026ndash;208. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1093/ajh/hpu041\u003c/span\u003e\u003cspan address=\"10.1093/ajh/hpu041\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVisanuyothin S, Plianbangchang S, Somrongthong R. An integrated program with home blood-pressure monitoring and village health volunteers for treating poorly controlled hypertension at the primary care level in an urban community of Thailand. Integr Blood Press Control 2018:25\u0026ndash;35. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2147/IBPC.S160548\u003c/span\u003e\u003cspan address=\"10.2147/IBPC.S160548\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHaricharan HJ, Heap M, Hacking D, Lau YK. Health promotion via SMS improves hypertension knowledge for deaf South Africans. BMC Public Health. 2017;17:1\u0026ndash;17. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1186/s12889-017-4619-7\u003c/span\u003e\u003cspan address=\"10.1186/s12889-017-4619-7\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePark H, Jang I. The effect of telephone counseling hypertension self-management program for hypertensive patients with disabilities using the welfare center for the disabled. J Korean Appl Sci Technol. 2020;37(4):659\u0026ndash;73. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.12925/jkocs.2020.37.4.659\u003c/span\u003e\u003cspan address=\"10.12925/jkocs.2020.37.4.659\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBranch RM. Instructional design: The ADDIE approach. Volume 722. New York: Springer; 2009.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChoi GW, Lee K-e, Chang SJ, Kim HJ. Health education interventions for individuals with hearing impairment: A systematic review. Patient Educ Couns. 2023;114:107830. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.pec.2023.107830\u003c/span\u003e\u003cspan address=\"10.1016/j.pec.2023.107830\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChoi GW, Chang SJ, Kim HJ, Jeong HN. Understanding health literacy of deaf persons with hypertension in South Korea: A cross-sectional study. PLoS ONE. 2023;18(11):e0294765. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1371/journal.pone.0294765\u003c/span\u003e\u003cspan address=\"10.1371/journal.pone.0294765\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJeong HN, Lee K-e, Kim HJ, Choi GW, Chang SJ. Silent struggles to self-manage high blood pressure among deaf sign language users: a qualitative study. Eur J Cardiovasc Nurs. 2024. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1093/eurjcn/zvad124\u003c/span\u003e\u003cspan address=\"10.1093/eurjcn/zvad124\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKountz DS. Strategies for improving low health literacy. Postgrad Med. 2009;121(5):171\u0026ndash;7. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3810/pgm.2009.09.2065\u003c/span\u003e\u003cspan address=\"10.3810/pgm.2009.09.2065\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDinh TTH, Bonner A, Clark R, Ramsbotham J, Hines S. The effectiveness of the teach-back method on adherence and self-management in health education for people with chronic disease: a systematic review. JBI Evid Synth. 2016;14(1):210\u0026ndash;47. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.11124/jbisrir-2016-2296\u003c/span\u003e\u003cspan address=\"10.11124/jbisrir-2016-2296\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKim TH, Jo MW, Lee SI, Kim SH, Chung SM. Psychometric properties of the EQ-5D-5L in the general population of South Korea. Qual Life Res. 2013;22(8):2245\u0026ndash;53. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s11136-012-0331-3\u003c/span\u003e\u003cspan address=\"10.1007/s11136-012-0331-3\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOh JH, Park E. The impact of health literacy on self-care behaviors among hypertensive elderly. Korean J Health Educ Promot. 2017;34(1):35\u0026ndash;45. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.14367/kjhep.2017.34.1.35\u003c/span\u003e\u003cspan address=\"10.14367/kjhep.2017.34.1.35\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKim S-S, Kim S-H, Lee S-Y. Health literacy: Development of a Korean health literacy assessment tool. Korean J Health Educ Promot. 2005;22(4):215\u0026ndash;27.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKim SH. Validation of the short version of Korean functional health literacy test. Int J Nurs Pract. 2017;23(4):e12559. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1111/ijn.12559\u003c/span\u003e\u003cspan address=\"10.1111/ijn.12559\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYoon J, Lee M, Ahn JS, Oh D, Shin S-Y, Chang YJ, Cho J. Development and validation of digital health technology literacy assessment questionnaire. J Med Syst. 2022;46(2):13. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s10916-022-01800-8\u003c/span\u003e\u003cspan address=\"10.1007/s10916-022-01800-8\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDickson VV, Lee C, Yehle KS, Abel WM, Riegel B. Psychometric Testing of the Self-care of Hypertension Inventory. J Cardiovasc Nurs. 2017;32(5):431\u0026ndash;8. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/jcn.0000000000000364\u003c/span\u003e\u003cspan address=\"10.1097/jcn.0000000000000364\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKim C-J, Park E, Schlenk EA, Kim M, Kim DJ. Psychometric evaluation of a Korean version of the Adherence to Refills and Medications Scale (ARMS) in adults with type 2 diabetes. Diabetes Educ. 2016;42(2):188\u0026ndash;98. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1177/0145721716632062\u003c/span\u003e\u003cspan address=\"10.1177/0145721716632062\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHan C, Jo SA, Kwak J-H, Pae C-U, Steffens D, Jo I, Park MH. Validation of the Patient Health Questionnaire-9 Korean version in the elderly population: the Ansan Geriatric study. Compr Psychiatry. 2008;49(2):218\u0026ndash;23. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.comppsych.2007.08.006\u003c/span\u003e\u003cspan address=\"10.1016/j.comppsych.2007.08.006\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGardner B, Lally P, Wardle J. Making health habitual: the psychology of \u0026lsquo;habit-formation\u0026rsquo;and general practice. Br J Gen Pract. 2012;62(605):664\u0026ndash;6. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3399/bjgp12X659466\u003c/span\u003e\u003cspan address=\"10.3399/bjgp12X659466\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLynn MR. Determination and quantification of content validity. Nurs Res. 1986;35(6):382\u0026ndash;6. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/00006199-198611000-00017\u003c/span\u003e\u003cspan address=\"10.1097/00006199-198611000-00017\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIn J. Introduction of a pilot study. Korean J anesthesiology 2017, 70(6):601.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJames PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507\u0026ndash;20. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1001/jama.2013.284427\u003c/span\u003e\u003cspan address=\"10.1001/jama.2013.284427\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePolit DF, Beck CT. The content validity index: are you sure you know what's being reported? Critique and recommendations. Res Nurs Health. 2006;29(5):489\u0026ndash;97. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1002/nur.20147\u003c/span\u003e\u003cspan address=\"10.1002/nur.20147\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePatel SR, Margolies PJ, Covell NH, Lipscomb C, Dixon LB. Using instructional design, analyze, design, develop, implement, and evaluate, to develop e-learning modules to disseminate supported employment for community behavioral health treatment programs in New York State. Front Public Health. 2018;6:113. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3389/fpubh.2018.00113\u003c/span\u003e\u003cspan address=\"10.3389/fpubh.2018.00113\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGavarkovs AG, Blunt W, Petrella RJ. A protocol for designing online training to support the implementation of community-based interventions. Eval Program Plann. 2019;72:77\u0026ndash;87. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.evalprogplan.2018.10.013\u003c/span\u003e\u003cspan address=\"10.1016/j.evalprogplan.2018.10.013\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMeherali S, Punjani NS, Mevawala A. Health literacy interventions to improve health outcomes in low-and middle-income countries. Health Lit Res Pract. 2020;4(4):e251\u0026ndash;66. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3928/24748307-20201118-01\u003c/span\u003e\u003cspan address=\"10.3928/24748307-20201118-01\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWalters R, Leslie SJ, Polson R, Cusack T, Gorely T. Establishing the efficacy of interventions to improve health literacy and health behaviours: a systematic review. BMC Public Health. 2020;20:1\u0026ndash;17. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1186/s12889-020-08991-0\u003c/span\u003e\u003cspan address=\"10.1186/s12889-020-08991-0\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBaur C, Martinez LM, Tchangalova N, Rubin D. A review and report of community-based health literacy interventions. 2017. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.13016/M2W66996Q\u003c/span\u003e\u003cspan address=\"10.13016/M2W66996Q\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHan H-R, Delva S, Greeno RV, Negoita S, Cajita M, Will W. A health literacy-focused intervention for Latinos with hypertension. Health Lit Res Pract. 2018;2(1):e21\u0026ndash;5. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3928/24748307-20180108-02\u003c/span\u003e\u003cspan address=\"10.3928/24748307-20180108-02\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDelavar F, Pashaeypoor S, Negarandeh R. The effects of self-management education tailored to health literacy on medication adherence and blood pressure control among elderly people with primary hypertension: A randomized controlled trial. Patient Educ Couns. 2020;103(2):336\u0026ndash;42. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.pec.2019.08.028\u003c/span\u003e\u003cspan address=\"10.1016/j.pec.2019.08.028\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLarsen MH, Mengshoel AM, Andersen MH, Borge CR, Ahlsen B, Dahl KG, Eik H, Holmen H, Lerdal A, Mariussen KL, et al. A bit of everything: Health literacy interventions in chronic conditions \u0026ndash; a systematic review. Patient Educ Couns. 2022;105(10):2999\u0026ndash;3016. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.pec.2022.05.008\u003c/span\u003e\u003cspan address=\"10.1016/j.pec.2022.05.008\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWarren-Findlow J, Coffman MJ, Thomas EV, Krinner LM. ECHO: a pilot health literacy intervention to improve hypertension self-care. Health Lit Res Pract. 2019;3(4):e259\u0026ndash;67. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3928/24748307-20191028-01\u003c/span\u003e\u003cspan address=\"10.3928/24748307-20191028-01\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTeague S, Youssef GJ, Macdonald JA, Sciberras E, Shatte A, Fuller-Tyszkiewicz M, Greenwood C, McIntosh J, Olsson CA, Hutchinson D. Retention strategies in longitudinal cohort studies: a systematic review and meta-analysis. BMC Med Res Methodol. 2018;18:1\u0026ndash;22. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1186/s12874-018-0586-7\u003c/span\u003e\u003cspan address=\"10.1186/s12874-018-0586-7\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Deaf, Education, Health literacy, Hearing impaired, Hypertension, Interventions","lastPublishedDoi":"10.21203/rs.3.rs-6242219/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6242219/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eWhile there is some research on hypertension self-management programs for Deaf individuals, there is no systematic program that considers their unique needs and health literacy. Given the high prevalence of hypertension among Deaf individuals and their vulnerability to limited health literacy, we developed Hypertension Self-Management education for the hearing-Impaired using sign LanguagE (H-SMILE) program, focusing on their health literacy.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eFollowing the Analysis, Design, Development, Implementation, and Evaluation model, this methodological study included: (1) analysis through literature review, surveys, and in-depth interviews; (2) draft design of the program; and (3) program development and expert validity evaluation. A pilot test was also conducted with five Deaf individuals with hypertension to assess the program\u0026rsquo;s feasibility.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eA 12-session program was developed, covering key topics such as definition of hypertension, dietary management, weight control, exercise, blood pressure monitoring, medication adherence, smoking and alcohol use cessation, and stress management. The program includes eight pre-recorded educational video sessions produced in Korean Sign Language (KSL) and four small-group in-person sessions for review and feedback. It integrates linguistic, functional, and digital health literacy to ensure a comprehensive and accessible approach for Deaf participants.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThe H-SMILE program is designed for Deaf individuals with hypertension and may be particularly beneficial for those with limited health literacy who use sign language. This program is expected to enhance health literacy, promote positive self-management behaviors, and ultimately contribute to improved health outcomes among Deaf individuals.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eThis study is registered with the Clinical Research Information Service (CRIS) in South Korea under the registration number KCT0008292 (registration date: March 7, 2023). Detailed information is available on the CRIS website (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://cris.nih.go.kr/\u003c/span\u003e\u003cspan address=\"https://cris.nih.go.kr/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e).\u003c/p\u003e","manuscriptTitle":"Development of a Health Literacy-Based Hypertension Self-Management Education Program Using Sign Language for Deaf Individuals","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-05 18:35:32","doi":"10.21203/rs.3.rs-6242219/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-08-07T11:23:53+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-08-07T05:31:44+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"200604073138059156015439656645338623629","date":"2025-07-21T22:15:27+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"150473833410393753449575347778724680999","date":"2025-06-20T19:09:13+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-24T01:31:47+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"17786154089425238324504483144361695989","date":"2025-04-03T16:40:07+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-04-01T13:31:23+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-28T08:35:49+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-03-28T04:48:58+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2025-03-28T04:47:52+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f9b64506-8c99-43f2-b7cf-c7ae2777b681","owner":[],"postedDate":"May 5th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-11-24T16:11:25+00:00","versionOfRecord":{"articleIdentity":"rs-6242219","link":"https://doi.org/10.1186/s12913-025-13726-1","journal":{"identity":"bmc-health-services-research","isVorOnly":false,"title":"BMC Health Services Research"},"publishedOn":"2025-11-20 15:58:47","publishedOnDateReadable":"November 20th, 2025"},"versionCreatedAt":"2025-05-05 18:35:32","video":"","vorDoi":"10.1186/s12913-025-13726-1","vorDoiUrl":"https://doi.org/10.1186/s12913-025-13726-1","workflowStages":[]},"version":"v1","identity":"rs-6242219","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6242219","identity":"rs-6242219","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}