Cultural adaptation of the ENABLE (Educate, Nurture, Advise, Before Life Ends) as an early palliative care model among heart failure patients and caregivers in Iran: A qualitative study protocol

Cultural adaptation of the ENABLE (Educate, Nurture, Advise, Before Life Ends) as an early palliative care model among heart failure patients and caregivers in Iran: A qualitative study protocol | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Cultural adaptation of the ENABLE (Educate, Nurture, Advise, Before Life Ends) as an early palliative care model among heart failure patients and caregivers in Iran: A qualitative study protocol Arvin Mirshahi, Ali Khanipour-Kencha, Marie Bakitas, J. Nicholas Odom, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4100313/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction : ENABLE (Educate, Nurture, Advise, Before Life Ends) is a model of nurse-led, early palliative care that was originally developed for U.S. patients with advanced cancer and their family caregivers and then adapted for patients with heart failure. ENABLE coaching topics include problem-solving, communication, advance care planning, symptom management, and self-care. The purpose of this paper is to detail a qualitative study protocol to assess the cultural acceptability of ENABLE among heart failure patients and their family caregivers in Iran. Methods and analysis: This is a qualitative study employing a thematic analysis approach. In the first phase, the translation and validation of ENABLE model contents will be conducted using the standard forward-backward method and an expert panel. In the second phase, through the purposive sampling method and by using semi-structured interviews, approximately 45 participants including heart failure patients (n≈15), their family caregivers (n≈15), and healthcare professionals involved in their care (n≈15) will be invited to participate in one-on-one semi-structured interviews exploring three main areas: (1) the primary needs and challenges faced by individuals with heart failure and their family caregivers, (2) the extent of patients’ involvement in healthcare decision-making, and (3) participants’ preferences for content and delivery method of ENABLE. Interview audio recordings will be transcribed verbatim and data will be analyzed using Clarke and Braun thematic analysis method including 1) Familiarization with the data, 2) Generating initial codes, 3) Searching for themes, 4) Reviewing themes, 5) Defining and naming themes, and 6) Preparing the report/manuscript. Study rigor will be assessed based on Lincoln and Guba’s gold standards: credibility, dependability, confirmability, and transferability. Ethics and dissemination: Ethical approval has been granted by Institutional Review Board at Tehran University of Medical Sciences (IR.TUMS.FNM.REC.1401.133). We expect to disseminate study findings through journal articles, conference presentations, and public and social multimedia. Palliative Care Cultural Adaptation ENABLE Qualitative Study Thematic Analysis Heart Failure Study Protocol Iran Figures Figure 1 Figure 2 Figure 3 Introduction Heart failure (HF) is characterized as a prevalent chronic disorder with a multitude of complexities and considerable morbidity and mortality (1). As with its high prevalence worldwide (2), HF prevalence in Iran is estimated to be high, at approximately 8% (3), making it a serious concern in the Iranian healthcare system (4). Patients afflicted with HF commonly experience debilitating clinical manifestations and recurrent episodes of disease exacerbation, leading to a decline functional capability and disruption of their daily activities (5). Moreover, the effective management of this disease is an intricate undertaking requiring significant lifestyle modifications, strict adherence to a multiple medication regimen, and regular medical visits (6) The uncertain and precarious trajectory of heart failure, along with the complexity of its management, not only affect the physical aspects of the disease but also have psychological and social implications, including depression, mental distress, and reduced quality of life (QoL) in both patients with HF (7,8), and their caregivers (9). Additionally, the impact of HF places significant strain on both patients and the healthcare system, leading to frequent hospitalizations, escalating healthcare expenses, and diminished QoL(10). All of these factors highlight the importance of a holistic approach for these patients. As an integrated and comprehensive approach, palliative care, focuses on early identification, correct assessment, and treatment of pain and other physical, psychosocial, or spiritual problems(11). This approach helps improve the QoL of patients facing serious diseases or life-threatening circumstances (12,13). Given the unpredictable trajectory of HF and the challenges in prognostication, it is recommended to integrate palliative care at an early stage when patients are still highly functional (14,15). While early palliative care has been explored for its potential benefits in maintaining or enhancing patients'QoL (16), the evidence presents a mixed picture, particularly in heart failure where findings remain equivocal. Previous studies have demonstrated the beneficial outcomes of early palliative care models and interventions in patients with serious conditions such as cancer (17,18), HF (19) or other severe diseases (16,20), with only one study focusing on early palliative care in Iranian heart failure patients (21). On the other hand, Iran currently lacks a well-defined and specific framework for providing palliative and supportive care, especially tailored for heart failure patients (22), highlighting the urgent need for action in this regard. One potential approach to address this gap is through the cultural adaptation of existing early palliative care interventions or models for the Iranian populace. Among these, the ENABLE model emerges as one of the most promising and evidence-based early palliative care interventions. ENABLE (Educate, Nurture, Advise, Before Life Ends) is a nurse coach-led, telehealth, potentially scalable model to integrate early palliative care for the patients and their caregivers (23,24). The ENABLE model provides comprehensive guidance and skills training to patients and family caregivers care, on common issues arising across the HF disease trajectory including effective symptom management, self-care , crisis prevention, problem-solving,decision-making, coping mechanisms, advance care planning, and approaches to facilitate communication between patients, families, and healthcare providers (25,26). Although, a growing body of literature has examined the significant impact of the ENABLE program on cancer patients and their caregivers (23,24), this model has had only limited testing on U.S. HF patients demonstrating feasibility (27) and some positive outcomes (19). Project ENABLE was originally designed for cancer patients living in rural states of the United States (26,28), and has been adapted for implementation in other geocultural contexts such as African-American communities (29), Turkey (30), and Singapore (31,32). Given the Medical Research Council (MRC) guidance, the feasibility, acceptability and effectiveness of complex interventions, such as ENABLE, depends on factors such as the community and cultural context in which the intervention is implemented (33). Therefore, cultural adaptation is the first critical step in determining the appropriate and effective principles for the implementation of care programs in different communities. Consequently, the ENABLE model has been generating considerable interest in terms of cultural adaptation as a comprehensive early palliative care model in diverse contexts (25). Although some aspects of ENABLE, such as symptom management are widely prevalent and cross-culturally relevant in HF patients, other topics such as advance care planning, spiritual needs, or the way the program would be delivered may differ in countries like Iran which has very different cultural backgrounds and religious beliefs (29,31,34). For example, thinking and planning about end-of-life, can be challenging in Iranian culture, where death is commonly perceived as a dreadful, grim and tragic event that could occur at any moment (35). Some believe that talking about death and severe conditions will cause these events to occur (36). In addition, a crucial component of dealing with HF is paying attention to the spirituality and religious beliefs of patients, especially in the highly religious Iran culture (37). For example, faith in God's will and divine destiny play a significant role in pursuing religious assistance and hope in Iranian society (34,38). Therefore, the perspectives, beliefs, cultural thoughts, and religious values of Iranian patients can influence their preferences about the health care they receive (39). This point must be taken into account when developing an intervention in this unique context (40). According to the MRC framework for developing and evaluating complex interventions, there are four perspectives that can be used to guide a complex intervention, including efficacy, effectiveness, theory based, and systems. The theory based perspective can be beneficial in adaptive intervention research, because it focuses on understanding how an intervention works and the interplay between mechanisms and context, thus emphasizing the importance of developing and testing theories that underpin the intervention and refining them as necessary(41). ENABLE, informed by Wagner's Chronic Care (CIC) model (27), which has also been used successfully to inform care for Iranian patients with chronic diseases (42). However, it is essential to evaluate whether the theoretical foundations of the CIC model remain applicable in a population of heart failure patients receiving early palliative care. As suggested by the MRC guidance, qualitative designs may be necessary to address questions that go beyond effectiveness, particularly in the context of adaptive intervention research, where interventions are tailored to specific populations and settings(41). It is generally believed that qualitative methods are valuable tools to explore the way an intervention can be improved because they can provide information on how and why a new method fails or succeeds, as well as how patients and providers perceive a care service (43). Since qualitative approaches provide in-depth information, perspectives and insights, this method could shed new light on ENABLE model in terms of cultural adaptation in Iranian context especially related to patients' spiritual, social, and cultural perspectives (44). These insights are of vital importance as they can reveal the intricacies and nuances of human behavior when faced with disease and its treatment (45). Due to the necessity of examining a suitable early palliative care model in HF patients and their caregivers in the cultural context of Iran and also the importance of investigating the cultural adaptation of care-providing models developed in other countries, this paper describes the study protocol to be used to meet study aims of exploring cultural relevance and modifications for an adapted ENABLE model in Iranian patients living with HF in a two-phase study as below: Objectives The objectives of this study are as follows: Main objective: Cultural adaptation of the ENABLE (Educate, Nurture, Advise, Before Life Ends) as an early palliative care model among heart failure patients and caregivers in Iran. The Specific Objective of the First Phase: Translation and validation of ENABLE model contents. The Specific Objective of the Second Phase: Semi-structured interviews with heart failure patients, their caregivers and healthcare providers to obtain their views on: 1) the clarity and appropriateness of the translated content and the text of the ENABLE intervention, 2) the relevance of translated ENABLE topics to the primary needs and challenges faced by individuals of patients and their caregivers, 3) and their preferred delivery method (such as phone or face-to-face). Materials and Methods Study design This qualitative study with a thematic analysis approach. According to critical realism, a thematic analysis approach will be used as one of the most straightforward ways of deducing patterns of meaning from qualitative data and as a technique that could be applicable within a wide range of qualitative research designs ( 46 , 47 ).Thematic analysis is an appropriate method for identifying, analyzing, and reporting on themes, which can organize and explain the subject under study ( 48 ). The process of cultural adaptation of the ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention will be implemented in two phases as follows: Phase ( 1 ) Translation and validation of ENABLE model contents and, Phase ( 2 ) Semi-structured interviews with heart failure patients, their caregivers and healthcare providers. The schematic diagram of the study can be seen in Fig. 1 The study is scheduled to commence on March 30, 2024, and is expected to conclude by September 10, 2024. The Institutional Review Board at Tehran University of Medical Sciences(TUMS) approved the study protocol (IR.TUMS.FNM.REC.1401.133). This manuscript complies with the Consolidated criteria for Reporting Qualitative research (COREQ) checklist relevant at the study protocol stage( 49 ). The Adaptation Process 1) Translation and validation of ENABLE program content: The content of the ENABLE program, as displayed in Fig. 2 , will be translated into Persian using the standard Forward-Backward method( 50 ). This methodology requires two forward translations into the target language by native speakers, a reconciled version of the two forward translations done by a third independent translator who is a native speaker of the target language, a back-translation of the reconciled version by an English speaker fluent in the target language, harmonization of the translation with other languages, and review/finalization by a native speaking linguist or health-related quality of life research expert. The validity of the translated content will be evaluated by an expert panel consisting of ten faculty members from TUMS with diverse specialties. This panel comprises six nursing faculty members who are experts in palliative care, critical care, and cardiovascular nursing, along with two psychologists and two heart failure specialists. Semi-structured interviews with heart failure patients, their caregivers and healthcare providers: After obtaining the written informed consent we will use an interview guide to conduct semi-structured interviews on: 1) the clarity and appropriateness of the translated content and the text of the ENABLE intervention, 2) the relevance of translated ENABLE topics to the primary needs and challenges faced by individuals of patients and their caregivers, 3) and their preferred delivery method (such as phone or face-to-face). These interviews will be conducted over two in-person sessions, in which pateints and their caregivers will be interviewed separately. During the first session, the study's objectives, needs, and challenges related to palliative care in heart failure will be explored, and an overview of the various aspects of the ENABLE program will be provided. As agreed beforehand, patients, caregivers and healthcare providers will have 3–7 days to review the content of the ENABLE program, which is provided to them in a booklet designed specifically for them in two versions (patient and caregiver version). In the second interview we will seek their opinions on the content, program fit with current needs, and suggestions for improvement. To ensure maximum diversity and access to information richness, patient/caregiver participants will be selected with maximum diversity in terms of age, gender, education, and duration of heart failure diagnosis. For health care providers we will seek diversity of age, gender, discipline and work experience. The inclusion of participants will persist until data saturation (at least 15 participants for each group) and a depth of findings are attained within all three groups of participants ( 51 ). At the end of the second session, as a token of appreciation for the time spent participating in the study, participants will be offered a 100 thousand Toman gift card. Recruitment and Participants Purposive sampling is a commonly employed technique in qualitative research, aimed at focusing on particular characteristics, knowledge or experience of a population that are of interest to helping answer the research question. In the present study, maximum variation sampling and expert sampling are considered to capture the widest and the most relevant perspectives possible ( 52 ). Using the purposive sampling method, all patient, family caregiver, and clinician participants will be selected and their opinions and viewpoints in the field of heart failure will be collected regarding heart failure patient needs, content covered by the ENABLE intervention, and their preferred delivery method of the intervention. The interview time and location will be determined based on the participant's preference and the request for participation, either at the Heart Clinic of Imam Khomeini Hospital Complex (IKHC) or at the Nursing and Midwifery School of Tehran University of Medical Sciences. See sample interview questions in Fig. 3 . 1) Patients All patients will be recruited from the heart failure clinic and the cardiovascular department of IKHC which is affiliated with TUMS. IKHC is the largest tertiary center in Iran, presently boasting nearly 400 faculty members, 4000 administrative and clinical staff, and more than 1300 active beds across its various specialist centers( 53 ). Nearly all of its patients are able to speak Persian as their first language. The inclusion criteria for the patients include: 1) being 18 years of age or older, 2) being able to communicate in Persian, 3) having a diagnosis of heart failure by a specialized cardiologist, 4) being New York Heart Association (NYHA) class II, III, or IV. The exclusion criteria include diagnosed and documented psychological disorders in their medical record (e.g., schizophrenia, bipolar disorder, or active substance use disorder). 2) Caregivers In this study, a family caregiver is defined as someone who is directly informed of a patient with heart failure of NYHA class II, III, their daily needs and takes care of the patient, ensures the provision of care to meet these needs, or is the decision-maker regarding meeting the patient's needs and providing care. The inclusion criteria for family caregivers include: 1) being 18 years of age or older, 2) being able to communicate in Persian, 3) self-endorses providing the majority of support and medical care to the patient due to his or her illness 4) not paid for their support, 5) may or may not live in the same home with the patient. The exclusion criteria include: diagnosed and documented psychological disorders (e.g., schizophrenia, bipolar disorder, or active substance use disorder). 3) Healthcare Providers Among those working as healthcare providers in IKHC, we will recruit HF cardiologists, palliative care nurses and physicians, nurses working in the cardiology department, and psychologists. The inclusion criteria for healthcare providers include having at least six months of work experience. Data collection and analysis To identify common themes among diverse perspectives and experiences of heart failure patients, family caregivers, and clinicians thematic analysis will be performed according to Braun and Clarke’s guide. In Braun and Clarke’s seminal work on thematic analysis, they underlined that thematic analysis is theoretically flexible for identifying, describing, and interpreting patterns so that its flexibility and transparency make the analysis more valid( 54 ). This method employs six stages for identifying and reporting on themes, including: 1) Familiarization with the data, 2) Generating initial codes, 3) Searching for themes, 4) Reviewing themes, 5) Defining and naming themes, and 6) Preparing the report / manuscript( 55 ). All interviews will digitally-recorded using audio format and transcribed verbatim. After transcription, the data will be reviewed multiple times to ensure familiarity with participant statements. Qualitative analysis will be aided by using MAXQDA software. Then, using in vivo coding, initial codes will be assigned to the data. After reviewing the initial codes, they will be, examined for how they group into themes, sub-themes and patterns. Next, the results, which will be in the form of codes and themes, will be summarized relative to how they guide the intervention adaptation and a final report will be prepared on the participants' views regarding the clarity, appropriateness, relevance of translated ENABLE topics to the needs of patients and caregivers and their preferred delivery method (such as phone or face-to-face) of the ENABLE program. Rigor and Trustworthiness In this qualitative study, the rigor and trustworthiness will be strengthened through a series of rigorous measures to ensure the study's validity and reliability ( 56 ). The first (Mr. AM) and corresponding author (Dr. AM) responsible for data analysis will avoid any influence from their prior knowledge or experiences working with other heart failure patients and their caregivers, as well as any preconceived thoughts. To ensure rigor in our qualitative research, multiple verification strategies will be employed: ( 1 ) Ensuring methodological coherence by aligning the research question with appropriate methods and data analysis procedures; ( 2 ) Selecting an appropriate sample that best represented or had knowledge of the research topic; ( 3 ) Using constant comparison analysis to establish a mutual interaction between existing knowledge and new findings; ( 4 )Thinking theoretically, confirming emerging ideas through validation with new data, and developing new insights based on previously collected data; and ( 5 ) Developing theory by carefully considering both micro and macro perspectives of the data and conceptual understanding. To enhance the trustworthiness of the findings, we will employ credibility, confirmability, and transferability as additional measures ( 57 ). To enhance study credibility, we will employ two strategies: data triangulation and peer debriefing. Data triangulation involves cross-validating information by gathering evidence from multiple sources, such as interview transcripts and relevant literature ( 58 ). This approach will help to strengthen the accuracy and reliability of the identified codes and themes. Furthermore, peer debriefing will be utilized as a means of confirming the emerging categories of needs. A second member of the research team (AKK) will review the interview transcripts and the newly identified categories, engaging in discussions to assess their relevance and novelty ( 56 , 57 ). This process of seeking input from a colleague will serve as a valuable method to challenge assumptions and promote a more comprehensive understanding of the findings. The concept of confirmability in research necessitates unbiased research procedures and results, as well as agreement on the meaning, relevance, and accuracy of findings obtained through data analysis ( 57 , 59 ). To achieve confirmability, the study will employ triangulation methods, as mentioned earlier. Rigor will be maintained by ensuring an adequate sample size, reaching data saturation, and adhering to the desired qualitative approach ( 46 , 56 ). Addressing transferability will involve obtaining a "thick description" of the findings, enabling their application to other contexts. This will be accomplished by providing clear descriptions of the research context, participant selection and characteristics, data collection procedures, and data analysis methods ( 57 ). By offering a comprehensive account of these elements, the findings will become more readily transferable and applicable to other settings. The primary analysis will be done by the lead researcher and the opinions of all members of the research team (consisting of different specialties) will be taken into account in relation to the emergent themes. All the personal information and interviews audio files will be collected and maintained by the principal investigator of the study in locked filing cabinets and behind password protected external drive that are accessible only to researchers. We will make available analytical memos to provide evidence of the major findings. Data will be reported in accordance with the Consolidated Criteria for Reporting Qualitative Research guidelines(COREQ)( 49 ). Study team The study team comprises nurses, clinicians, researchers and academics with expertise and specialist training in heart failure and palliative care. Also the principal investigators of the ENABLE program, Dr. Marie Bakitas, Dr. J. Nicholas Odom and Dr. Rachel Wells, will provide consultation on steps of cultural adaptation and study rigor. Patient and Public Involvement There was no patient and public involvement in the development of this protocol. Discussion Heart failure's uncertain course and management challenges impact not just patients physically but also induce psychological and social burdens, including depression and diminished quality of life for both patients and caregivers( 7 – 9 ). Furthermore, the strain of heart failure results in frequent hospitalizations, increased healthcare costs, and reduced overall quality of life ( 10 ). There is a vast amount of literature on simultaneous administration of palliative care in conjunction with standard HF treatment at an early stage can reduce HF symptoms and enhance QoL, alleviate both physical and emotional distress, and potentially lower the frequency of hospitalizations ( 60 ). However, Studies of palliative care in Iran are limited ( 10 , 61 , 62 ), creating challenges and opportunities in developing culturally appropriate and well-structured palliative care programs for Iranian patients living with HF ( 21 , 63 , 64 ). The ENABLE model is a well-established palliative care intervention demonstrated to improve outcomes for U.S. HF patients ( 19 ). However, its use in other cultural contexts, such as Iran, requires adaptation to the specific cultural, social, and healthcare system characteristics of the host country. The geocultural context is one of the most significant factors that determines how patients perceive their illness and wish to receive medical care. Likewise, the cultural background, religious attitude, and healthcare infrastructure in Iran have a considerable impact on patients' values, beliefs, and preferences. Therefore, this study protocol proposes a qualitative study on HF patients, their family caregivers, and healthcare providers to adapt ENABLE palliative care model for patients with HF and their caregivers in Iran. Conducting a rigorous, formative evaluation qualitative study will provide a deep understanding of HF patients' and caregivers' needs and preferences, and healthcare providers’ suggestions for delivering an integrated palliative care approach. The findings of this study will determine cultural differences and crucial factors that can be used to enhance the effectiveness of the ENABLE program for HF patients and their family caregivers in the Iranian setting. The modified and adapted ENABLE CHF-PC model will hold potential for utilization in upcoming studies in the Iranian context. Strengths and limitations One of the primary strengths of this study lies in its comprehensive approach, utilizing a qualitative method with thematic analysis to delve deeply into the perspectives and experiences of heart failure patients, their caregivers, and healthcare providers concerning palliative care. Furthermore, the study's adherence to qualitative research principles, including purposive sampling, data triangulation, and peer debriefing, bolsters the credibility and reliability of the findings. Additionally, the emphasis on interdisciplinary collaboration, drawing upon a diverse team of researchers and experts in heart failure and palliative care, along with guidance from principal investigators of the original ENABLE model, underscores the robust and well-informed nature of the cultural adaptation approach. Limitations of the study include potential bias due to the use of purposive sampling, which may limit the generalizability of findings; however, this will be mitigated by employing maximum variation sampling and expert sampling to capture diverse perspectives. Another limitation is the reliance on self-reported data, which could introduce response bias; to address this, efforts will be made to establish rapport and trust with participants during data collection, encouraging candid and honest responses. Additionally, the study's findings may be influenced by the cultural context of Iran and the specific healthcare setting at Tehran University of Medical Sciences, potentially limiting their transferability to other contexts; however, by providing detailed descriptions of the research context, participant characteristics, and data collection procedures, the study aims to enhance the transferability of its findings. Finally, while efforts will be made to ensure methodological rigor through measures such as data triangulation and peer debriefing, the subjective nature of qualitative research may introduce interpretation bias; however, this will be addressed by involving multiple researchers in data analysis and regularly reviewing emerging themes to enhance the reliability of findings. Abbreviations HF: Heart failure QoL: quality of life ENABLE: Educate, Nurture, Advise, Before Life Ends MRC: Medical Research Council CIC: Wagner's Chronic Care model ENABLE CHF-PC: Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers TUMS: Tehran University of Medical Sciences COREQ: Consolidated criteria for Reporting Qualitative research IKHC: Imam Khomeini Hospital Complex NYHA: New York Heart Association Declarations Ethics approval and consent to participate The study protocol was approved by the Institutional Review Board at Tehran University of Medical Sciences (Code: IR.TUMS.FNM.REC.1401.133). All participants provided written informed consent. Consent for publication Not applicable Availability of data and materials The datasets that will be generated and/or analyzed during the current study are not publicly available due to potential risks to research participant privacy. The data may contain sensitive information that could compromise participants' confidentiality. Therefore, we are unable to make the data publicly available at this time. The final dataset will be securely stored at the Faculty of Nursing and Midwifery at TUMS. Both paper files and a password-protected external drive will be stored in a locked filing cabinet that is only accessible to authorized researchers. This will ensure that the data is kept confidential and is not accessible to unauthorized personnel. Upon reasonable request, the corresponding author can provide analytical notes that demonstrate the development and reduction of themes. These notes will include codes, themes, and quotations used in the analysis process. Please note that these notes will be provided at the discretion of the corresponding authors and will only be shared with authorized personnel. Competing interests The authors declare that they have no competing interests. Funding There are no funders supporting this study. Authors’ contributions AM envisioned the idea and with the supports of Dr.AM and Prof. MB, took the leadership role in gathering team members to write the research proposal and this protocol manuscript. AM wrote the research proposal with assistance of AKK. Dr. MB, Dr. JNO and Dr.RW are the principal investigators of the original ENABLE-CHF-PC intervention from the Univeristy of Alabama at Birmingham. They helped in conceptualizing and designing the study based on their rich experinces on this field. All authors - Mr. AM, Mr. AKK, Dr. MB, Dr. JNO, Dr. RW, and Dr. AM critically reviewed, revised the manuscript, and approved the final manuscript for submission. All authors have read and approved the final version of the manuscript. Acknowledgements We would like to acknowledge the contributions of the Medical-Surgical Nursing Department of the School of Nursing and Midwifery affiliated with TUMS to the project approval and their ongoing support. We also thank Ms. Hadis Enayati for designing the Persian version of ENABLE program contents. References Malik A, Brito D, Vaqar S, Chhabra L, Doerr C. Congestive Heart Failure (Nursing). In: StatPearls. Treasure Island (FL); 2022. Savarese G, Becher PM, Lund LH, Seferovic P, Rosano G, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2022;118(17):3272–87. Mahdavi-Roshan M, Vakilpour A, Mousavi SM, Ashouri A. Dietary diversity and food security status among heart failure patients in the north of Iran. BMC Nutr. 2021;7(1):1–9. Esnaasharieh F, Dehghan M, Mangolian Shahrbabaki P. The relationship between sleep quality and physical activity among patients with heart failure: a cross-sectional study. 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J Educ Health Promot [Internet]. 2021 Oct 1 [cited 2023 Jul 26];10(1). Available from: /pmc/articles/PMC8641730/ . Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, et al. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015;33(13):1438. Dionne-Odom JN, Azuero A, Lyons KD, Hull JG, Tosteson T, Li Z, et al. Benefits of Early Versus Delayed Palliative Care to Informal Family Caregivers of Patients With Advanced Cancer: Outcomes From the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015;33(13):1446. Akyar I, Dionne-Odom J, Yang G, Bakitas M. Translating a US Early Palliative Care Model for Turkey and Singapore. Asia-Pacific J Oncol Nurs. 2018;5(1):33. Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, et al. Effects of a Palliative Care Intervention on Clinical Outcomes in Patients With Advanced Cancer: The Project ENABLE II Randomized Controlled Trial. JAMA. 2009;302(7):741–9. Dionne-Odom JN, Kono A, Frost J, Jackson L, Ellis D, Ahmed A, et al. Translating and Testing the ENABLE: CHF-PC Concurrent Palliative Care Model for Older Adults with Heart Failure and Their Family Caregivers. J Palliat Med. 2014;17(9):995. Bakitas M, Stevens M, Ahles T, Kirn M, Skalla K, Kane N, et al. Project ENABLE: a palliative care demonstration project for advanced cancer patients in three settings. J Palliat Med. 2004;7(2):363–72. Hendricks BA, Lofton C, Azuero A, Kenny M, Taylor RA, Huang C-HS, et al. The project ENABLE Cornerstone randomized pilot trial: Protocol for lay navigator-led early palliative care for African-American and rural advanced cancer family caregivers. Contemp Clin Trials Commun. 2019;16:100485. Akyar I, Dionne-Odom JN, Ozcan M, Bakitas MA. Needs Assessment for Turkish Family Caregivers of Older Persons with Cancer: First-Phase Results of Adapting an Early Palliative Care Model. J Palliat Med. 2019;22(9):1065–74. Yang GM, Dionne-Odom JN, Foo YH, Chung AHM, Kamal NHA, Tan L, et al. Adapting ENABLE for patients with advanced cancer and their family caregivers in Singapore: a qualitative formative evaluation. BMC Palliat Care. 2021;20(1):86. Ke Y, Cheung YB, Bakitas M, Odom JN, Lum E, Tan DSW, et al. ENABLE-SG (Educate, Nurture, Advise, Before Life Ends for Singapore) as a proactive palliative care model: protocol for a hybrid type 1 effectiveness-implementation randomized wait-list controlled trial. BMC Palliat Care. 2024;23(1):29. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. Farahani MA, Mohammadi E, Ahmadi F, Maleki M, Hajizadeh E. Cultural barriers in the education of cardiovascular disease patients in Iran. Int Nurs Rev. 2008;55(3):360–6. Abedi M. Palliative Care within the Iranian Context: Re-Defining Palliative Care, Deploying Spirituality as a Support Measure and Need for Cultural Sensitivity. In Leiden, The Netherlands: Brill; 2013. pp. 249–58. Farahani AS, Rassouli M, Mojen LK, Ansari M, Ebadinejad Z, Tabatabaee A et al. The feasibility of home palliative care for cancer patients: the perspective of Iranian nurses. Int J Cancer Manag. 2018;11(8). Mangolian Shahrbabaki PP, Nouhi EP, Kazemi MP, Ahmadi FP. Spirituality: A Panacea for Patients Coping with Heart Failure. Int J community based Nurs midwifery. 2017;5(1):38–48. Cheraghi MA, Manookian A, Nasrabadi AN. Human dignity in religion-embedded cross-cultural nursing. Nurs Ethics. 2014;21(8):916–28. Rassouli M, Farahan AS, Mojen LK, Ashrafizadeh H. The Impact of Culture and Beliefs on Cancer Care. Global Perspectives in Cancer Care: Religion, Spirituality, and Cultural Diversity in Health and Healing. Oxford University Press; 2022. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061. Abolhassani Shahreza F, Hazar N. Implementation of Chronic Care Model for Diabetes Care in Iranian Primary Health Care: Does it work? Iran J Diabetes Obes. 2018;10(4):164–71. Hamilton AB, Finley EP. Qualitative Methods in Implementation Research: An Introduction. Psychiatry Res. 2019;280:112516. Lee C-W, Wu W, Tan Z-Y, Yang C-F. Qualitative study of the cross-cultural adaptation of Macao students in Mainland China. Educ Sci. 2020;10(5):128. Sandelowski M, Barroso J. Writing the proposal for a qualitative research methodology project. Qual Health Res. 2003;13(6):781–820. Polit D, Beck C. Essentials of Nursing Research: Appraising Evidence for Nursing Practice. Wolters Kluwer Health; 2020. Braun V, Clarke V, Hayfield N. Thematic analysis: A reflexive approach. In SAGE; 2023. Grove S, Burns N, Gray J. The practice of nursing research: Appraisal, synthesis, and generation of evidence. 2012. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Heal care J Int Soc Qual Heal Care. 2007;19(6):349–57. Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000;25(24):3186–91. Francis JJ, Johnston M, Robertson C, Glidewell L, Entwistle V, Eccles MP, et al. What is an adequate sample size? Operationalising data saturation for theory-based interview studies. Psychol Health. 2010;25(10):1229–45. Baran ML. Mixed methods research for improved scientific study. IGI Global; 2016. Imam Khomeini Hospital Complex [Internet]. p. 105. Available from: https://en.tums.ac.ir/en/page/105/imam-khomeini-hospital-complex . Braun V, Clarke V. Reflecting on reflexive thematic analysis. Qual Res Sport Exerc Heal. 2019;11(4):589–97. Kiger M, Teacher LV-M. 2020 U. Thematic analysis of qualitative data: AMEE Guide No. 131. Taylor Fr. 2020;42(8):846–54. Adler RH. Trustworthiness in qualitative research. J Hum Lact. 2022;38(4):598–602. Pandey SC, Patnaik S. Establiashing reliability and validity in qualitative inquiry: A critical examination. Jharkhand J Dev Manag Stud. 2014;12(1):5743–53. Ray R. Designing and Conducting Mixed Methods Research [Book Review]. Vol. 7, Qualitative Research Journal. Sage publications; 2007. 90–91 p. Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004;24(2):105–12. Wells R, Stockdill ML, Dionne-Odom JN, Ejem D, Burgio KL, Durant RW et al. Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers (ENABLE CHF-PC): study protocol for a randomized controlled trial. Trials. 2018;19(1). Sadat Bahador R, Ghanbarzehi N, Arefi F, Afrazandeh S. The impact of palliative care program on quality of life in patients with chronic heart failure. Int J Pharm Res Allied Sci. 2016;5:174–9. Bahador RS, Nouhi E, Jahani Y. The study of palliative care and its relationship with quality of life in patients with chronic heart failure. in 2014–2015. J Clin Nurs Midwifery. 2017;5(4):35–46. [persian]. Bagheri I, Hashemi N, Bahrami M. Current State of Palliative Care in Iran and Related Issues: A Narrative Review. Iran J Nurs Midwifery Res. 2021;26(5):380–91. Bagheri I, Yousefi H, Bahrami M, Shafie D. Adaptation of Interdisciplinary Clinical Practice Guidelines to Palliative Care for Patients with Heart Failure in Iran: Application of AdapteMethod. Iran J Nurs Midwifery Res. 2023;28(1):92–8. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4100313","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":281253874,"identity":"297aca13-847e-42e5-97f6-977a32860ecf","order_by":0,"name":"Arvin Mirshahi","email":"","orcid":"","institution":"Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Arvin","middleName":"","lastName":"Mirshahi","suffix":""},{"id":281253875,"identity":"a471777e-ecf7-4b27-94da-f04fd280c748","order_by":1,"name":"Ali Khanipour-Kencha","email":"","orcid":"","institution":"Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Ali","middleName":"","lastName":"Khanipour-Kencha","suffix":""},{"id":281253876,"identity":"3e190f03-92ba-495e-aedc-e2298bbca9c1","order_by":2,"name":"Marie Bakitas","email":"","orcid":"","institution":"University of Alabama at Birmingham","correspondingAuthor":false,"prefix":"","firstName":"Marie","middleName":"","lastName":"Bakitas","suffix":""},{"id":281253877,"identity":"ad735417-4752-4f01-b86a-e46cb3df992a","order_by":3,"name":"J. Nicholas Odom","email":"","orcid":"","institution":"University of Alabama at Birmingham","correspondingAuthor":false,"prefix":"","firstName":"J.","middleName":"Nicholas","lastName":"Odom","suffix":""},{"id":281253878,"identity":"0cb9293d-76af-42ab-b8ca-0f4549a2a553","order_by":4,"name":"Rachel Wells","email":"","orcid":"","institution":"University of Alabama at Birmingham","correspondingAuthor":false,"prefix":"","firstName":"Rachel","middleName":"","lastName":"Wells","suffix":""},{"id":281253879,"identity":"0722bd9c-fb11-4fd1-a750-0c718730106d","order_by":5,"name":"Arpi Manookian","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABEklEQVRIiWNgGAWjYDADCWYg8YFBAlmMsYGgFsYZYC3MxGoBqeUBM5nxKmTgn32AdcPPHTZyku3Mzx7b/LHI42/gPyZ14w+DPH8Dc9sHbIafS2C72XsmzViamc3cOLdNoljiADObdG4bg+GMA4zNM7BZc4b/2w3etsOJ85gZzKRzGyQSG8BaGhgYNzAwNmPTIX+Gge3mX7AW9m/SFn8kEueDtOT8YbDHpcUAqOU2yJbZzDxm0gxsEokbwFrYGBJxaTEEaZFtSzOWbOYpk+xtk0jceJjZ2BroqeQZh7FrkQM57G2bjZzE+ePbJH78qUucd7zx4e2cPza2/e3tj3GEMzqARIsEwfgZBaNgFIyCUYAbAAATnFb0cwNeIgAAAABJRU5ErkJggg==","orcid":"","institution":"Tehran University of Medical Sciences","correspondingAuthor":true,"prefix":"","firstName":"Arpi","middleName":"","lastName":"Manookian","suffix":""}],"badges":[],"createdAt":"2024-03-14 11:32:44","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4100313/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4100313/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":53196758,"identity":"6ae703a6-053c-4b96-99d5-6f83ed19aa22","added_by":"auto","created_at":"2024-03-21 18:34:56","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1546045,"visible":true,"origin":"","legend":"\u003cp\u003eSchematic diagram of the study\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4100313/v1/dcc40709881bfd8a032c8e9b.jpg"},{"id":53196760,"identity":"c10d1a17-033d-475e-ba3b-d5185605c552","added_by":"auto","created_at":"2024-03-21 18:34:56","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":841610,"visible":true,"origin":"","legend":"\u003cp\u003eContent outline of ENABLE sessions\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4100313/v1/45a592069904cfbc68575d3b.jpg"},{"id":53196759,"identity":"18b0e8b2-d2d4-4a02-8596-842272941fd6","added_by":"auto","created_at":"2024-03-21 18:34:56","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":1284713,"visible":true,"origin":"","legend":"\u003cp\u003eGuiding questions for the interview\u003c/p\u003e","description":"","filename":"Figure3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4100313/v1/bbc187596a1cb04048fe48ba.jpg"},{"id":60178558,"identity":"80a9d5dd-2fad-49cd-986c-3d751fd9d084","added_by":"auto","created_at":"2024-07-12 16:41:00","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":4191294,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4100313/v1/835411bc-dbff-4aa3-bfe4-08a9492e6653.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Cultural adaptation of the ENABLE (Educate, Nurture, Advise, Before Life Ends) as an early palliative care model among heart failure patients and caregivers in Iran: A qualitative study protocol","fulltext":[{"header":"Introduction","content":"\u003cp\u003eHeart failure (HF) is characterized as a \u0026nbsp;prevalent chronic disorder with a multitude of complexities and considerable morbidity and mortality\u0026nbsp;(1). As with its high prevalence worldwide\u0026nbsp;(2), HF prevalence in Iran is estimated to be high, at approximately 8%\u0026nbsp;(3), making it a serious concern in the Iranian healthcare system\u0026nbsp;(4). Patients afflicted with HF commonly experience debilitating clinical manifestations and recurrent episodes of disease exacerbation, leading to a decline functional capability and disruption of their daily activities\u0026nbsp;(5).\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003eMoreover, the effective management of this disease is an intricate undertaking requiring significant lifestyle modifications, strict adherence to a multiple medication regimen, and regular medical visits\u0026nbsp;(6)\u0026nbsp;The uncertain and precarious trajectory of heart failure, along with the complexity of its management, not only affect the physical aspects of the disease but also have psychological and social implications, including depression, mental distress, and reduced quality of life (QoL) in both patients with HF\u0026nbsp;(7,8), and their caregivers\u0026nbsp;(9). Additionally, the impact of HF places significant strain on both patients and the healthcare system, leading to frequent hospitalizations, escalating healthcare expenses, and diminished QoL(10). All of these factors highlight the importance of a holistic approach for these patients.\u003c/p\u003e\n\u003cp\u003eAs an integrated and comprehensive approach, palliative care, focuses on early identification, correct assessment, and treatment of pain and other physical, psychosocial, or spiritual problems(11). This approach helps improve the QoL of patients facing serious diseases or life-threatening circumstances\u0026nbsp;(12,13). Given the unpredictable trajectory of HF and the challenges in prognostication, it is recommended to integrate palliative care at an early stage when patients are still highly functional\u0026nbsp;(14,15). While early palliative care has been explored for its potential benefits in maintaining or enhancing patients\u0026apos;QoL\u0026nbsp;(16), the evidence presents a mixed picture, particularly in heart failure where findings remain equivocal.\u0026nbsp;Previous studies have demonstrated the beneficial outcomes of early palliative care models and interventions in patients with serious conditions such as cancer\u0026nbsp;(17,18), HF\u0026nbsp;(19)\u0026nbsp;or other severe diseases\u0026nbsp;(16,20), with only one study focusing on early palliative care in Iranian heart failure patients\u0026nbsp;(21). On the other hand, Iran currently lacks a well-defined and specific framework for providing palliative and supportive care, especially tailored for heart failure patients\u0026nbsp;(22), highlighting the urgent need for action in this regard. One potential approach to address this gap is through the cultural adaptation of existing early palliative care interventions or models for the Iranian populace. Among these, the ENABLE model emerges as one of the most promising and evidence-based early palliative care interventions.\u003c/p\u003e\n\u003cp\u003eENABLE (Educate, Nurture, Advise, Before Life Ends) is a nurse coach-led, telehealth, potentially scalable model to integrate early palliative care for the patients and their caregivers\u0026nbsp;(23,24). \u0026nbsp; The ENABLE model provides comprehensive guidance and skills training to patients and family caregivers care, on common issues arising across the HF disease trajectory including effective symptom management, self-care , crisis prevention, \u0026nbsp;problem-solving,decision-making, coping mechanisms, advance care planning, and approaches to facilitate communication between patients, families, and healthcare providers\u0026nbsp;(25,26). Although, a growing body of literature has examined the significant impact of the ENABLE program on cancer patients and their caregivers\u0026nbsp;(23,24), \u0026nbsp; this model has had only limited testing on U.S. HF patients demonstrating feasibility\u0026nbsp;(27)\u0026nbsp;and some positive outcomes\u0026nbsp;(19). Project ENABLE was originally designed for cancer patients living in rural states of the United States\u0026nbsp;(26,28), and has been adapted for implementation in other geocultural contexts such as African-American communities\u0026nbsp;(29), Turkey\u0026nbsp;(30), and Singapore\u0026nbsp;(31,32).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eGiven the Medical Research Council (MRC) guidance, the feasibility, acceptability and effectiveness of \u0026nbsp;complex interventions, such as ENABLE, depends on factors such as the community and cultural context in which the intervention is implemented\u0026nbsp;(33). Therefore, cultural adaptation is the first critical step in determining the appropriate and effective principles for the implementation of care programs in different communities. Consequently, \u0026nbsp;the ENABLE model \u0026nbsp;has been generating considerable interest in terms of cultural adaptation as a comprehensive early palliative care model in diverse contexts\u0026nbsp;(25). Although some aspects of ENABLE, such as symptom management are widely prevalent and cross-culturally relevant in HF patients, other topics such as advance care planning, spiritual needs, or the way the program would be delivered may differ in countries like Iran which has very different cultural backgrounds and religious beliefs\u0026nbsp;(29,31,34). For example, thinking and planning about end-of-life, can be challenging in Iranian culture, where death is commonly perceived as a dreadful, grim and tragic event that could occur at any moment\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003e(35).\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003eSome believe that talking about death and severe conditions will cause these events to occur\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003e(36). In addition, a crucial component of dealing with HF is paying attention to the spirituality and religious beliefs of patients, especially in the highly religious Iran culture\u0026nbsp;(37). For example, faith in God\u0026apos;s will and divine destiny play a significant role in pursuing religious assistance and hope in Iranian society\u0026nbsp;(34,38). Therefore, the perspectives, beliefs, cultural thoughts, and religious values of Iranian patients can influence their preferences about the health care they receive\u0026nbsp;(39). This point must be taken into account when developing an intervention in \u0026nbsp;this unique context\u0026nbsp;(40).\u003c/p\u003e\n\u003cp\u003eAccording to the MRC framework for developing and evaluating complex interventions, there are four perspectives that can be used to guide a complex intervention, including efficacy, effectiveness, theory based, and systems. The theory based perspective can be beneficial in adaptive intervention research, because it focuses on understanding how an intervention works and the interplay between mechanisms and context, thus emphasizing the importance of developing and testing theories that underpin the intervention and refining them as necessary(41).\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003eENABLE, informed by Wagner\u0026apos;s\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003eChronic Care (CIC) model\u0026nbsp;(27), which has also been used successfully to inform care for Iranian patients with chronic diseases\u0026nbsp;(42). However, it is essential to evaluate whether the theoretical foundations of the CIC model remain applicable in a population of heart failure patients receiving early palliative care. As suggested by the MRC guidance, qualitative designs may be necessary to address questions that go beyond effectiveness, particularly in the context of adaptive intervention research, where interventions are tailored to specific populations and settings(41). It is generally believed that qualitative methods are valuable tools to explore the way an intervention can be improved because they can provide information on how and why a new method fails or succeeds, as well as how patients and providers perceive a care service\u0026nbsp;(43). Since qualitative approaches provide in-depth information, perspectives and insights, this method could shed new light on ENABLE model in terms of cultural adaptation in Iranian context especially related to patients\u0026apos; spiritual, social, and cultural perspectives\u0026nbsp;(44). These insights are of vital importance as they can reveal the intricacies and nuances of human behavior when faced with disease and its treatment\u0026nbsp;(45).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDue to the necessity of examining a suitable early palliative care model in HF patients and their caregivers in the cultural context of Iran and also the importance of investigating the cultural adaptation of care-providing models developed in other countries, this paper describes the study protocol to be used to meet study aims of exploring cultural relevance and modifications for an adapted ENABLE model in Iranian patients living with HF in a two-phase study as below:\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjectives\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe objectives of this study are as follows:\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMain objective:\u0026nbsp;\u003c/strong\u003eCultural adaptation of the ENABLE (Educate, Nurture, Advise, Before Life Ends) as an early palliative care model among heart failure patients and caregivers in Iran.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe Specific Objective of the First Phase:\u0026nbsp;\u003c/strong\u003eTranslation and validation of ENABLE model contents.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe Specific Objective of the Second Phase:\u0026nbsp;\u003c/strong\u003eSemi-structured interviews with heart failure patients, their caregivers and healthcare providers to obtain their views on: 1) the clarity and appropriateness of the translated content and the text of the ENABLE intervention, 2) the relevance of translated ENABLE topics to the primary needs and challenges faced by individuals of patients and their caregivers, 3) and their preferred delivery method (such as phone or face-to-face).\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003eThis qualitative study with a thematic analysis approach. According to critical realism, a thematic analysis approach will be used as one of the most straightforward ways of deducing patterns of meaning from qualitative data and as a technique that could be applicable within a wide range of qualitative research designs (\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e, \u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e).Thematic analysis is an appropriate method for identifying, analyzing, and reporting on themes, which can organize and explain the subject under study (\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e). The process of cultural adaptation of the ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention will be implemented in two phases as follows: Phase (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) Translation and validation of ENABLE model contents and, Phase (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) Semi-structured interviews with heart failure patients, their caregivers and healthcare providers. The schematic diagram of the study can be seen in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e The study is scheduled to commence on March 30, 2024, and is expected to conclude by September 10, 2024. The Institutional Review Board at Tehran University of Medical Sciences(TUMS) approved the study protocol (IR.TUMS.FNM.REC.1401.133). This manuscript complies with the Consolidated criteria for Reporting Qualitative research (COREQ) checklist relevant at the study protocol stage(\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eThe Adaptation Process\u003c/b\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e1) Translation and validation of ENABLE program content:\u003c/h2\u003e \u003cp\u003eThe content of the ENABLE program, as displayed in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, will be translated into Persian using the standard Forward-Backward method(\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e). This methodology requires two forward translations into the target language by native speakers, a reconciled version of the two forward translations done by a third independent translator who is a native speaker of the target language, a back-translation of the reconciled version by an English speaker fluent in the target language, harmonization of the translation with other languages, and review/finalization by a native speaking linguist or health-related quality of life research expert. The validity of the translated content will be evaluated by an expert panel consisting of ten faculty members from TUMS with diverse specialties. This panel comprises six nursing faculty members who are experts in palliative care, critical care, and cardiovascular nursing, along with two psychologists and two heart failure specialists.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eSemi-structured interviews with heart failure patients, their caregivers and healthcare providers:\u003c/h2\u003e \u003cp\u003eAfter obtaining the written informed consent we will use an interview guide to conduct semi-structured interviews on: 1) the clarity and appropriateness of the translated content and the text of the ENABLE intervention, 2) the relevance of translated ENABLE topics to the primary needs and challenges faced by individuals of patients and their caregivers, 3) and their preferred delivery method (such as phone or face-to-face). These interviews will be conducted over two in-person sessions, in which pateints and their caregivers will be interviewed separately. During the first session, the study's objectives, needs, and challenges related to palliative care in heart failure will be explored, and an overview of the various aspects of the ENABLE program will be provided. As agreed beforehand, patients, caregivers and healthcare providers will have 3\u0026ndash;7 days to review the content of the ENABLE program, which is provided to them in a booklet designed specifically for them in two versions (patient and caregiver version). In the second interview we will seek their opinions on the content, program fit with current needs, and suggestions for improvement. To ensure maximum diversity and access to information richness, patient/caregiver participants will be selected with maximum diversity in terms of age, gender, education, and duration of heart failure diagnosis. For health care providers we will seek diversity of age, gender, discipline and work experience. The inclusion of participants will persist until data saturation (at least 15 participants for each group) and a depth of findings are attained within all three groups of participants (\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e). At the end of the second session, as a token of appreciation for the time spent participating in the study, participants will be offered a 100 thousand Toman gift card.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eRecruitment and Participants\u003c/h2\u003e \u003cp\u003ePurposive sampling is a commonly employed technique in qualitative research, aimed at focusing on particular characteristics, knowledge or experience of a population that are of interest to helping answer the research question. In the present study, maximum variation sampling and expert sampling are considered to capture the widest and the most relevant perspectives possible (\u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e). Using the purposive sampling method, all patient, family caregiver, and clinician participants will be selected and their opinions and viewpoints in the field of heart failure will be collected regarding heart failure patient needs, content covered by the ENABLE intervention, and their preferred delivery method of the intervention. The interview time and location will be determined based on the participant's preference and the request for participation, either at the Heart Clinic of Imam Khomeini Hospital Complex (IKHC) or at the Nursing and Midwifery School of Tehran University of Medical Sciences. See sample interview questions in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003e1) Patients\u003c/h2\u003e \u003cp\u003eAll patients will be recruited from the heart failure clinic and the cardiovascular department of IKHC which is affiliated with TUMS. IKHC is the largest tertiary center in Iran, presently boasting nearly 400 faculty members, 4000 administrative and clinical staff, and more than 1300 active beds across its various specialist centers(\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e). Nearly all of its patients are able to speak Persian as their first language. The inclusion criteria for the patients include: 1) being 18 years of age or older, 2) being able to communicate in Persian, 3) having a diagnosis of heart failure by a specialized cardiologist, 4) being New York Heart Association (NYHA) class II, III, or IV. The exclusion criteria include diagnosed and documented psychological disorders in their medical record (e.g., schizophrenia, bipolar disorder, or active substance use disorder).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003e2) Caregivers\u003c/h2\u003e \u003cp\u003eIn this study, a family caregiver is defined as someone who is directly informed of a patient with heart failure of NYHA class II, III, their daily needs and takes care of the patient, ensures the provision of care to meet these needs, or is the decision-maker regarding meeting the patient's needs and providing care. The inclusion criteria for family caregivers include: 1) being 18 years of age or older, 2) being able to communicate in Persian, 3) self-endorses providing the majority of support and medical care to the patient due to his or her illness 4) not paid for their support, 5) may or may not live in the same home with the patient. The exclusion criteria include: diagnosed and documented psychological disorders (e.g., schizophrenia, bipolar disorder, or active substance use disorder).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003e3) Healthcare Providers\u003c/h2\u003e \u003cp\u003eAmong those working as healthcare providers in IKHC, we will recruit HF cardiologists, palliative care nurses and physicians, nurses working in the cardiology department, and psychologists. The inclusion criteria for healthcare providers include having at least six months of work experience.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eData collection and analysis\u003c/h2\u003e \u003cp\u003e To identify common themes among diverse perspectives and experiences of heart failure patients, family caregivers, and clinicians thematic analysis will be performed according to Braun and Clarke\u0026rsquo;s guide. In Braun and Clarke\u0026rsquo;s seminal work on thematic analysis, they underlined that thematic analysis is theoretically flexible for identifying, describing, and interpreting patterns so that its flexibility and transparency make the analysis more valid(\u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e54\u003c/span\u003e). This method employs six stages for identifying and reporting on themes, including: 1) Familiarization with the data, 2) Generating initial codes, 3) Searching for themes, 4) Reviewing themes, 5) Defining and naming themes, and 6) Preparing the report / manuscript(\u003cspan citationid=\"CR55\" class=\"CitationRef\"\u003e55\u003c/span\u003e). All interviews will digitally-recorded using audio format and transcribed verbatim. After transcription, the data will be reviewed multiple times to ensure familiarity with participant statements. Qualitative analysis will be aided by using MAXQDA software. Then, using in vivo coding, initial codes will be assigned to the data. After reviewing the initial codes, they will be, examined for how they group into themes, sub-themes and patterns. Next, the results, which will be in the form of codes and themes, will be summarized relative to how they guide the intervention adaptation and a final report will be prepared on the participants' views regarding the clarity, appropriateness, relevance of translated ENABLE topics to the needs of patients and caregivers and their preferred delivery method (such as phone or face-to-face) of the ENABLE program.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eRigor and Trustworthiness\u003c/h2\u003e \u003cp\u003eIn this qualitative study, the rigor and trustworthiness will be strengthened through a series of rigorous measures to ensure the study's validity and reliability (\u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e). The first (Mr. AM) and corresponding author (Dr. AM) responsible for data analysis will avoid any influence from their prior knowledge or experiences working with other heart failure patients and their caregivers, as well as any preconceived thoughts. To ensure rigor in our qualitative research, multiple verification strategies will be employed: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) Ensuring methodological coherence by aligning the research question with appropriate methods and data analysis procedures; (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) Selecting an appropriate sample that best represented or had knowledge of the research topic; (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) Using constant comparison analysis to establish a mutual interaction between existing knowledge and new findings; (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)Thinking theoretically, confirming emerging ideas through validation with new data, and developing new insights based on previously collected data; and (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) Developing theory by carefully considering both micro and macro perspectives of the data and conceptual understanding.\u003c/p\u003e \u003cp\u003eTo enhance the trustworthiness of the findings, we will employ credibility, confirmability, and transferability as additional measures (\u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e). To enhance study credibility, we will employ two strategies: data triangulation and peer debriefing. Data triangulation involves cross-validating information by gathering evidence from multiple sources, such as interview transcripts and relevant literature (\u003cspan citationid=\"CR58\" class=\"CitationRef\"\u003e58\u003c/span\u003e). This approach will help to strengthen the accuracy and reliability of the identified codes and themes. Furthermore, peer debriefing will be utilized as a means of confirming the emerging categories of needs. A second member of the research team (AKK) will review the interview transcripts and the newly identified categories, engaging in discussions to assess their relevance and novelty (\u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e, \u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e). This process of seeking input from a colleague will serve as a valuable method to challenge assumptions and promote a more comprehensive understanding of the findings. The concept of confirmability in research necessitates unbiased research procedures and results, as well as agreement on the meaning, relevance, and accuracy of findings obtained through data analysis (\u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e, \u003cspan citationid=\"CR59\" class=\"CitationRef\"\u003e59\u003c/span\u003e). To achieve confirmability, the study will employ triangulation methods, as mentioned earlier. Rigor will be maintained by ensuring an adequate sample size, reaching data saturation, and adhering to the desired qualitative approach (\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e, \u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e). Addressing transferability will involve obtaining a \"thick description\" of the findings, enabling their application to other contexts. This will be accomplished by providing clear descriptions of the research context, participant selection and characteristics, data collection procedures, and data analysis methods (\u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e). By offering a comprehensive account of these elements, the findings will become more readily transferable and applicable to other settings.\u003c/p\u003e \u003cp\u003eThe primary analysis will be done by the lead researcher and the opinions of all members of the research team (consisting of different specialties) will be taken into account in relation to the emergent themes. All the personal information and interviews audio files will be collected and maintained by the principal investigator of the study in locked filing cabinets and behind password protected external drive that are accessible only to researchers. We will make available analytical memos to provide evidence of the major findings. Data will be reported in accordance with the Consolidated Criteria for Reporting Qualitative Research guidelines(COREQ)(\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eStudy team\u003c/h2\u003e \u003cp\u003eThe study team comprises nurses, clinicians, researchers and academics with expertise and specialist training in heart failure and palliative care. Also the principal investigators of the ENABLE program, Dr. Marie Bakitas, Dr. J. Nicholas Odom and Dr. Rachel Wells, will provide consultation on steps of cultural adaptation and study rigor.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003ePatient and Public Involvement\u003c/h2\u003e \u003cp\u003eThere was no patient and public involvement in the development of this protocol.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eHeart failure's uncertain course and management challenges impact not just patients physically but also induce psychological and social burdens, including depression and diminished quality of life for both patients and caregivers(\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Furthermore, the strain of heart failure results in frequent hospitalizations, increased healthcare costs, and reduced overall quality of life (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). There is a vast amount of literature on simultaneous administration of palliative care in conjunction with standard HF treatment at an early stage can reduce HF symptoms and enhance QoL, alleviate both physical and emotional distress, and potentially lower the frequency of hospitalizations (\u003cspan citationid=\"CR60\" class=\"CitationRef\"\u003e60\u003c/span\u003e). However, Studies of palliative care in Iran are limited (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR61\" class=\"CitationRef\"\u003e61\u003c/span\u003e, \u003cspan citationid=\"CR62\" class=\"CitationRef\"\u003e62\u003c/span\u003e), creating challenges and opportunities in developing culturally appropriate and well-structured palliative care programs for Iranian patients living with HF (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR63\" class=\"CitationRef\"\u003e63\u003c/span\u003e, \u003cspan citationid=\"CR64\" class=\"CitationRef\"\u003e64\u003c/span\u003e). The ENABLE model is a well-established palliative care intervention demonstrated to improve outcomes for U.S. HF patients (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). However, its use in other cultural contexts, such as Iran, requires adaptation to the specific cultural, social, and healthcare system characteristics of the host country.\u003c/p\u003e \u003cp\u003eThe geocultural context is one of the most significant factors that determines how patients perceive their illness and wish to receive medical care. Likewise, the cultural background, religious attitude, and healthcare infrastructure in Iran have a considerable impact on patients' values, beliefs, and preferences. Therefore, this study protocol proposes a qualitative study on HF patients, their family caregivers, and healthcare providers to adapt ENABLE palliative care model for patients with HF and their caregivers in Iran. Conducting a rigorous, formative evaluation qualitative study will provide a deep understanding of HF patients' and caregivers' needs and preferences, and healthcare providers\u0026rsquo; suggestions for delivering an integrated palliative care approach. The findings of this study will determine cultural differences and crucial factors that can be used to enhance the effectiveness of the ENABLE program for HF patients and their family caregivers in the Iranian setting. The modified and adapted ENABLE CHF-PC model will hold potential for utilization in upcoming studies in the Iranian context.\u003c/p\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eStrengths and limitations\u003c/h2\u003e \u003cp\u003eOne of the primary strengths of this study lies in its comprehensive approach, utilizing a qualitative method with thematic analysis to delve deeply into the perspectives and experiences of heart failure patients, their caregivers, and healthcare providers concerning palliative care. Furthermore, the study's adherence to qualitative research principles, including purposive sampling, data triangulation, and peer debriefing, bolsters the credibility and reliability of the findings. Additionally, the emphasis on interdisciplinary collaboration, drawing upon a diverse team of researchers and experts in heart failure and palliative care, along with guidance from principal investigators of the original ENABLE model, underscores the robust and well-informed nature of the cultural adaptation approach. Limitations of the study include potential bias due to the use of purposive sampling, which may limit the generalizability of findings; however, this will be mitigated by employing maximum variation sampling and expert sampling to capture diverse perspectives. Another limitation is the reliance on self-reported data, which could introduce response bias; to address this, efforts will be made to establish rapport and trust with participants during data collection, encouraging candid and honest responses. Additionally, the study's findings may be influenced by the cultural context of Iran and the specific healthcare setting at Tehran University of Medical Sciences, potentially limiting their transferability to other contexts; however, by providing detailed descriptions of the research context, participant characteristics, and data collection procedures, the study aims to enhance the transferability of its findings. Finally, while efforts will be made to ensure methodological rigor through measures such as data triangulation and peer debriefing, the subjective nature of qualitative research may introduce interpretation bias; however, this will be addressed by involving multiple researchers in data analysis and regularly reviewing emerging themes to enhance the reliability of findings.\u003c/p\u003e \u003c/div\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eHF: Heart failure\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eQoL: quality of life\u003c/p\u003e\n\u003cp\u003eENABLE: Educate, Nurture, Advise, Before Life Ends\u003c/p\u003e\n\u003cp\u003eMRC: Medical Research Council\u003c/p\u003e\n\u003cp\u003eCIC: Wagner\u0026apos;s\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003eChronic Care model\u003c/p\u003e\n\u003cp\u003eENABLE CHF-PC:\u0026nbsp;Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers\u003c/p\u003e\n\u003cp\u003eTUMS: Tehran University of Medical Sciences\u003c/p\u003e\n\u003cp\u003eCOREQ: Consolidated criteria for Reporting Qualitative research\u003c/p\u003e\n\u003cp\u003eIKHC: Imam Khomeini Hospital Complex\u003c/p\u003e\n\u003cp\u003eNYHA: New York Heart Association\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study protocol was approved by the Institutional Review Board at Tehran University of Medical Sciences (Code: IR.TUMS.FNM.REC.1401.133). All participants provided written informed consent.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets that will be generated and/or analyzed during the current study are not publicly available due to potential risks to research participant privacy. The data may contain sensitive information that could compromise participants\u0026apos; confidentiality. Therefore, we are unable to make the data publicly available at this time. The final dataset will be securely stored at the Faculty of Nursing and Midwifery at TUMS. Both paper files and a password-protected external drive will be stored in a locked filing cabinet that is only accessible to authorized researchers. This will ensure that the data is kept confidential and is not accessible to unauthorized personnel. Upon reasonable request, the corresponding author can provide analytical notes that demonstrate the development and reduction of themes. These notes will include codes, themes, and quotations used in the analysis process. Please note that these notes will be provided at the discretion of the corresponding authors and will only be shared with authorized personnel.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere are no funders supporting this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAM envisioned the idea and with the supports of Dr.AM and Prof. MB, took the leadership role in gathering team members to write the research proposal and this protocol manuscript. AM wrote the research proposal with assistance of AKK. Dr. MB, Dr. JNO and Dr.RW are the principal investigators of the original ENABLE-CHF-PC intervention from the Univeristy of Alabama at Birmingham. They helped in conceptualizing and designing the study based on their\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003erich experinces on this field. All authors - Mr. AM, Mr. AKK, Dr. MB, Dr. JNO, Dr. RW, and Dr. AM critically reviewed, revised the manuscript, and approved the final manuscript for submission. All authors have read and approved the final version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to acknowledge the contributions of the Medical-Surgical Nursing Department of the School of Nursing and Midwifery affiliated with TUMS to the project approval and their ongoing support. We also thank Ms. Hadis Enayati for designing the Persian version of \u0026nbsp;ENABLE program contents.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eMalik A, Brito D, Vaqar S, Chhabra L, Doerr C. Congestive Heart Failure (Nursing). In: StatPearls. Treasure Island (FL); 2022.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSavarese G, Becher PM, Lund LH, Seferovic P, Rosano G, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2022;118(17):3272\u0026ndash;87.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMahdavi-Roshan M, Vakilpour A, Mousavi SM, Ashouri A. Dietary diversity and food security status among heart failure patients in the north of Iran. BMC Nutr. 2021;7(1):1\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEsnaasharieh F, Dehghan M, Mangolian Shahrbabaki P. The relationship between sleep quality and physical activity among patients with heart failure: a cross-sectional study. BMC Sports Sci Med Rehabil. 2022;14(1):20.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSnipelisky D, Chaudhry S-P, Stewart GC. The Many Faces of Heart Failure. Card Electrophysiol Clin. 2019;11(1):11\u0026ndash;20.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHeidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, et al. 2022 ACC/AHA/HFSA Guideline for the Management of Heart Failure. J Card Fail. 2022;28(5):e1\u0026ndash;167.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoshki M, Khajavi A, Hashemizadeh H, Vakilian F, Minaee S, Martin SS. Dark or Bright Half of the Moon: A Qualitative Study Exploring the Experience of Iranian Heart Failure Patients Regarding their Quality of Life. Open access Maced J Med Sci. 2019;7(5):824\u0026ndash;30.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWingham J, Harding G, Britten N, Dalal H. Heart failure patients\u0026rsquo; attitudes, beliefs, expectations and experiences of self-management strategies: A qualitative synthesis. Chronic Illn. 2013;10(2):135\u0026ndash;54.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKim K-A, Park J-S, Seo K-W, Choi E-Y, Ahn J-A. Factors affecting the quality of life of family caregivers of patients with heart failure: A cross-sectional study. Med (Baltim). 2022;101(35):e30042.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMirshahi A, Ghiasvandian S, Khoshavi M, Riahi SM, Khanipour-Kencha A, Bakitas M, et al. The feasibility and acceptability of an early tele-palliative care intervention to improve quality of life in heart failure patients in Iran: A protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2023;33:101114.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWorld Health Organization. (2013). WHO Definition of Palliative Care. 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[persian].\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBagheri I, Hashemi N, Bahrami M. Current State of Palliative Care in Iran and Related Issues: A Narrative Review. Iran J Nurs Midwifery Res. 2021;26(5):380\u0026ndash;91.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBagheri I, Yousefi H, Bahrami M, Shafie D. Adaptation of Interdisciplinary Clinical Practice Guidelines to Palliative Care for Patients with Heart Failure in Iran: Application of AdapteMethod. Iran J Nurs Midwifery Res. 2023;28(1):92\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Palliative Care, Cultural Adaptation, ENABLE, Qualitative Study, Thematic Analysis, Heart Failure, Study Protocol, Iran","lastPublishedDoi":"10.21203/rs.3.rs-4100313/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4100313/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction\u003c/strong\u003e: ENABLE (Educate, Nurture, Advise, Before Life Ends) is a model of nurse-led, early palliative care that was originally developed for U.S. patients with advanced cancer and their family caregivers and then adapted for patients with heart failure. ENABLE coaching topics include problem-solving, communication, advance care planning, symptom management, and self-care. The purpose of this paper is to detail a qualitative study protocol to assess the cultural acceptability of ENABLE among heart failure patients and their \u0026nbsp;family caregivers in Iran.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods and analysis:\u003c/strong\u003e This is a qualitative study employing a thematic analysis approach. In the first phase, the translation and validation of ENABLE model contents will be conducted using the standard forward-backward method and an expert panel. In the second phase, through the purposive sampling method and by using semi-structured interviews, approximately 45 participants including heart failure patients (n≈15), their family caregivers (n≈15), and healthcare professionals involved in their care (n≈15) will be invited to participate in one-on-one semi-structured interviews exploring three main areas: (1) the primary needs and challenges faced by individuals with heart failure and their family caregivers, (2) the extent of patients’ involvement in healthcare decision-making, and (3) participants’ preferences for \u0026nbsp;content and delivery method of ENABLE. Interview audio recordings will be transcribed verbatim and data will be analyzed using Clarke and Braun thematic analysis method including 1) Familiarization with the data, 2) Generating initial codes, 3) Searching for themes, 4) Reviewing themes, 5) Defining and naming themes, and 6) Preparing the report/manuscript. Study rigor will be assessed based on Lincoln and Guba’s gold standards: credibility, dependability, confirmability, and transferability.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics and dissemination:\u003c/strong\u003e Ethical approval has been granted by Institutional Review Board at Tehran University of Medical Sciences (IR.TUMS.FNM.REC.1401.133). We expect to disseminate study findings through journal articles, conference presentations, and public and social multimedia.\u003c/p\u003e","manuscriptTitle":"Cultural adaptation of the ENABLE (Educate, Nurture, Advise, Before Life Ends) as an early palliative care model among heart failure patients and caregivers in Iran: A qualitative study protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-21 18:34:51","doi":"10.21203/rs.3.rs-4100313/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"e1117227-bf51-4e8a-b075-dfa2d09969d3","owner":[],"postedDate":"March 21st, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-07-12T16:32:52+00:00","versionOfRecord":[],"versionCreatedAt":"2024-03-21 18:34:51","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4100313","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4100313","identity":"rs-4100313","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}