Managing Dry Eye Disease in Primary Sjögren's Syndrome with the Chronic Disease Care Model

Managing Dry Eye Disease in Primary Sjögren's Syndrome with the Chronic Disease Care Model | 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 Research Article Managing Dry Eye Disease in Primary Sjögren's Syndrome with the Chronic Disease Care Model Jia Xin Liu, Jing Mei Shi, Shuo Zhang, Wen Jing Song This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9202023/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Purposes: To study the changes in lifestyle, disease control, and psychological mood of patients with primary Sjögren's syndrome when the chronic disease nursing model is implemented for dry eye management. Methods: A self-controlled pre-post trial. Tertiary hospitals in Beijing served as the chronic disease management units for this study. All study subjects were given chronic care dry eye management and completed 24 weeks of follow-up. The scores of SPEED questionnaire, OSDI questionnaire, VAS scale, Knowledge-Attitude-Practice questionnaire of dry eye patients using eye drops, and DASS scale were used to evaluate the changes of subjects' medication compliance, ocular symptoms, knowledge, belief and behavior of eye drops and psychology during the 24-week follow-up, and analyze the important influence of chronic disease nursing model on eye symptoms of patients with primary Sjogren's syndrome. Results: A total of 34 study subjects were collected in this trial, with a high retention rate. 91.19% (n = 31) of study subjects completed the 24-week follow-up. The 24-week intervention and follow-up resulted in high and stable adherence to home-based medication and self-care among participants. Significant improvements were also observed in their knowledge, and practices related to eye drop use, along with the resolution of adverse psychological emotions. Conclusion: The findings indicate that dry eye management based on a chronic care model empowers patients to adopt healthy lifestyles and alleviates negative emotions, thereby contributing to improved health outcomes. Trail registration: Its registration center is Chinese Clinical Trial Registry, the trial registration number is ChiCTR2500099615, and the registration date is 2025-03-26 00:00:00. Primary Sjögren's syndrome dry eye chronic disease management chronic disease care model health coaching techniques Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Introduction Sjögren's syndrome (SS) is a chronic, systemic autoimmune disease characterized by lymphocyte infiltration into exocrine organs, including salivary glands, lacrimal glands, and parotid glands, resulting in dry mouth and eye symptoms and parotid gland enlargement [ 1 ] . It is divided into primary Sjögren's syndrome (pSS) and secondary Sjögren's syndrome. PSS is characterized by immune abnormalities of the innate immune system, leading to B cell stimulation, autoantibody production, and inflammation of salivary and lacrimal glands, mainly with other multiple organ involvement [ 2 ] , with a prevalence of about 0.033‰-1.03‰ [ 3 ] . Dry eye is one of the most common symptoms in patients with pSS, and its incidence rate is as high as 92.71% [ 4 ] . It is also one of the important criteria for diagnosing pSS [ 5 ] . The symptoms of dry eye in patients with pSS are usually moderate to severe, and the clinical manifestations include eye discomfort and visual impairment such as foreign body sensation, dry eyes, itchy eyes, photophobia, or tear reduction. In severe cases, recurrent purulent infection of the eyelid margin, conjunctivitis, keratitis, and other infectious inflammation may occur, and visual loss may also occur in the late stage [ 6 ] . In addition, pSS is not only a physiological disease, but also a challenge to the psychological level of patients [ 7 ] . First, its chronic character and the persistence of symptoms significantly reduce the quality of life of patients. Long-term physical discomfort, such as persistent dry mouth, dry eyes, and other possible accompanying symptoms, such as joint pain, fatigue, etc., restricts the patient's daily activities. This condition tends to make patients feel helpless and depressed, thus increasing the risk of depression [ 8 ] . Secondly, because pSS is a progressive disease, about 30% of patients can suffer from multiple organ dysfunction and severe systemic manifestations in the later stage of the disease, and these patients usually can only get treatment for one symptom at a time. For example, patients go to the ophthalmology department for treatment of dry eye, but if they want to improve the symptoms of dry mouth, they need to go to the stomatology department, and when they want to improve the symptoms of dry skin, they need to go to the dermatology department [ 9 – 13 ] . In addition, due to the influence of the disease, patients may reduce their participation in social activities such as parties and travel. In the absence of social support and understanding, this sense of social isolation will further aggravate their negative emotions, such as depression, anxiety, and fatigue, and even autonomic dysfunction may occur in severe cases [ 14 ] . The course of pSS is long, the condition is repeated and changeable. Compared with other patients with dry eye, the symptoms are the most severe, the treatment is the most difficult, and some patients have severe negative emotions. Therefore, long-term medical monitoring and follow-up of people suffering from this disease are needed. A study from the National Institute of Medical and Nutritional Sciences of Mexico [ 15 ] pointed out that only 67% of pSS patients received treatment for systemic symptoms, and 35.2% of them would stop taking drugs on their own due to adverse drug reactions, lack of efficacy, or poor compliance. No research on patients' eye treatment and compliance has been found. Therefore, it is of great significance to study and improve patients' compliance with eye treatment and standardize patients' dry eye management for improving patients' mood and long-term prognosis. Chronic disease management (CDM) is a scientific management model that provides comprehensive, continuous, and active management for patients with chronic non-communicable diseases to promote patient health, delay disease development, reduce disability rate, reduce medical expenses, and improve quality of life [ 16 ] . Globally, there are no relevant research reports on systemic and ocular CDM of pSS patients, and the management of pSS patients in most countries is still in the exploratory stage. Extensive literature review indicates that a wide array of chronic disease nursing models and CDM paradigms currently exist in both national and global healthcare systems. Different models have different elements to consider. Therefore, it is necessary to review and evaluate the existing models and select the most suitable model for pSS patients to apply and evaluate its effect. Searching in PubMed, a total of 5 models were retrieved, including the Chronic Care Model (CCM), Improving Chronic Care (ICIC), Innovative Care for Chronic Conditions (ICCC), the Stanford Chronic Disease Self-Management Program (CDSMP), and the Transitional Care Model (TCM) [ 17 ] . CCM is a model of care developed by Wagner in 2002 that provides a proactive, patient-centered, evidence-based approach to promoting high-quality care for chronically ill patients. CCM includes six elements: healthcare organization, clinical information system, decision support, delivery system design, self-management support, and community. In foreign countries, CCM has been widely used in chronic diseases such as cardiovascular disease, cancer, chronic respiratory disease and diabetes, and has achieved good results in lifestyle improvement, clinical outcome improvement, patient satisfaction and disease knowledge awareness rate [ 18 – 26 ] , so CCM was finally selected as the theoretical framework guide of this study. CCM requires the participation of doctors, nurses, and patients. Doctors need to assess the severity of patients' diseases and formulate personalized treatment plans. As a bridge between doctors and patients, nurses play many important roles in the process of chronic disease management, such as communicating with patients and their families, implementing health education, long-term follow-up, observing patients' needs, and giving timely feedback [ 27 ] , etc. At present, there are few related studies on CDM in pSS patients worldwide. However, once it is incurable for life, chronic disease management is particularly important for such patients, and pSS involves multiple organs throughout the body. In the whole process of chronic disease management, it needs the participation of multidisciplinary teams to maximize the promotion of patients' physical and mental health and delay disease progression. Whether it is to establish a multidisciplinary cooperative team or develop a new medical treatment model of joint diagnosis, treatment, and care for pSS patients, we are all facing huge challenges. Therefore, we need to study the comprehensive and full-cycle management of chronic diseases for pSS patients, and explore the latest care models and methods suitable for this group of people. This study applies the CCM framework to explore its feasibility in managing dry eye in patients with pSS, including specific implementation methods, as well as its effects on the psychological foundation and practical nursing insights for CDM in pSS. On the other hand, it seeks to offer clinical reference evidence for multidisciplinary, lifelong disease management in a broader range of chronic conditions. Methods Study design The study is a self-controlled before-and-after trial. We calculated the sample size by G * Power 3.1, and the calculation showed that we needed 34 sample size. From April 2022 to Octeber 2023, pSS patients who were treated in the ophthalmology clinics of tertiary hospitals in Beijing were recruited, and the doctors in the chronic disease management team formulated personalized treatment plans for the patients. The patients who volunteered to participate in the 24-week follow-up of chronic disease management were collected as the study subjects, with a total of 34 study subjects at the time of enrollment. At enrollment, participants were invited to complete five questionnaires: the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire [ 28 ] , the Ocular Surface Disease Index (OSDI) questionnaire [ 29 ] , the Compliance questionnaire [ 30 ] , the Depression, Anxiety and Stress Scale−21 (DASS−21) questionnaire [ 31 ] , and the Knowledge, Attitudes, and Practices (KAP) regarding eye drop use questionnaire [ 32 ] . These assessments were repeated at the 4 th , 12 th , and 24 th weeks of the 24-week CDM program to evaluate changes from baseline across different dimensions. The detailed study flow is shown in Fig. 1 . This study is reported in accordance with the CONSORT statement for non-randomized trails. Participants From April 2022 to October 2023, patients with pSS were recruited from tertiary hospitals in Beijing. Upon enrollment, each participant was assigned a unique identification number based on their entry sequence to anonymize the data. This study was approved by the Biomedical Research Ethics Committee of Peking University First Hospital (Approval No.2021 Scientific Research 320), and written informed consent was obtained from all participants prior to inclusion. Inclusion criteria: (1) Meet the diagnostic criteria of pSS in the Classification Criteria for Primary Sjogren's Syndrome published by the American College of Rheumatology (ACR) and the European Alliance Against Rheumatism (EULAR) in 2016 [ 33 ] , which is based on the weighted sum of 5 items: anti-SSA/Ro antibody positivity and focal lymphocytic sialadenitis with a focus score of ≥ 1 foci/4 mm 2 , each scoring 3; Individuals with abnormal ocular staining score ≥ 5, Schirmer test result ≤ 5 mm/5 min, unstimulated saliva flow rate ≤ 0. 1 ml/min, score 1 for each item, with signs and symptoms suggestive of SS and a total score ≥ 4 for the above items are diagnostic criteria for pSS; (2) Age 18–65 years old; (3) The course of pSS ≥ 3 months; (4) Combined with different degrees of dry eye symptoms; (5) Be able to implement the treatment plan and follow-up as required; (6) Informed consent to voluntarily participate in this study. Exclusion criteria: (1) Women preparing for pregnancy, pregnant and breastfeeding; (2) Combined with fundus disease or active ocular surface disease; (3) Severe hearing and visual impairment; (4) Severe heart, brain, lung, liver, kidney and other organ damage or dysfunction; (5) Malignant tumor; (6) Unable to take care of yourself; (7) Participating in other interventional studies. Subjects who meet the inclusion criteria of the experimental group are invited to participate in the study, and with their consent, the chronic disease management team will conduct an intervention for 24 weeks. Interventions Under the guidance of the CCM theoretical framework, the six elements included in it are further designed: medical care organization, clinical information system, decision support, delivery system design, self-management support, and community. At the level of the healthcare organization, a pSS management team composed of ophthalmologists and nurses from Peking University First Hospital was established. Because the symptoms of pSS in the eye are caused by lacrimal gland involvement, an attending physician from the subspecialty group of corneal and ocular surface diseases was invited to join the team and provide clinical decision-making support. Because it is necessary to carry out ophthalmic diagnosis and treatment for patients, a nurse who has obtained the certificate of ophthalmic specialist nurse of the Chinese Nursing Association is invited to join the team. Because it is necessary to implement health education, follow-up, and feedback for patients through literature research and clinical actual situation, a nurse with evidence-based medicine learning experience and more than 5 years of clinical work experience in ophthalmology was invited to join the team. Because it is necessary to supervise and control the quality of the management team, a head nurse with more than 25 years of clinical experience in ophthalmology is invited to join the team. At the level of the clinical information system, a personal file is established for each enrolled study subject. The file is discussed and designed by the management team, including the number, name, gender, age, medical history, medication, and contact telephone number. The results of each eye examination and changes in condition are also recorded in the file, and the file will prompt the patient's time of each telephone follow-up and outpatient visit to avoid loss of follow-up caused by forgetting. Personal files are kept by the management team in a unified way, and two-person verification is completed each time to avoid data loss. At the level of decision support, we can learn the latest theoretical knowledge by consulting the literature and combine the experience of clinical diagnosis and treatment to construct a feasible personalized treatment plan. Before the start of the study, the management team conducted individual studies and group discussions, and the attending physician conducted unified training and assessment of nurses. Throughout the study, the attending physician formulated the treatment plan of the study subjects and made corresponding adjustments according to the results of each examination. At the level of delivery system design, Health coaching (HC) technology is adopted as a medical process to improve the lifestyle of pSS patients. HC is the practice of health education and health promotion under the background of coaching, including eight steps: contact, observation, strengthening, clarification, help, encouragement, education, and guidance, to promote the realization of patients' goals related to personal health [ 34 ] . At present, it has been widely used in the health education of patients with diabetes, chronic obstructive pulmonary disease, cancer, stroke, and depression, and some studies have confirmed that it has achieved positive results in patients' self-management of diseases [ 35 – 39 ] . Intervene with patients through face-to-face, distribution of health education sheets and medication guidance cards, WeChat cloud consultation, and telephone communication. Follow the eight steps of HC, work out personalized and feasible plan goals with patients, make patients master the plan content by means of model demonstration and video push, and follow up with the patients for 24 weeks. The specific implementation process is shown in Table 1 . This study involved non-invasive CDM interventions without pre-specified safety monitoring indicators. Participation was voluntary, and participants could withdraw at any time. Table 1 HC-specific implementation process procedure target Contents Form Time 1. Contact Gain patient trust, establish good communication, and master patient diagnosis and treatment plan Introduce themselves with patients, establish their personal files, use SPEED questionnaire, OSDI questionnaire, compliance questionnaire and DASS scale to evaluate the disease degree, medication status and psychological situation of patients, provide disease guidance for patients, and make health plans together with patients Face-to-face ≥ 30 min/ time 2. observe Understand patient awareness and health needs Use the knowledge-attitude-behavior questionnaire to evaluate the cognition of patients, understand the part and reasons that patients think it is difficult to implement the health plan through verbal communication, push relevant videos, and get contact information for later observation of patients' implementation Face-to-face ≥ 30 min/ time 3. intensify Emphasize the importance of compliance and facilitate patient implementation of health plans Reduce the psychological pressure of patients who think it is difficult to implement health education through communication skills such as listening, empathy, and feedback; Help patients establish self-management and develop a healthy lifestyle by issuing medication guidance cards, telephone, or WeChat follow-up at least once a week Face-to-face/ WeChat cloud consultation/ telephone ≥ 10 min/ time 4. Clarification Ensure the correctness and effectiveness of health plan implementation When it is found that patients lack a correct understanding of disease knowledge, the use of eye drops and the development of healthy habits, they should be explained and explained to patients; If patients have other related questions and needs, they should thoroughly understand the causes of their confusion and give correct and feasible health guidance in time; If the patient has a problem that cannot be solved online, the patient should be informed that he must see a doctor offline in time Face-to-face/ WeChat cloud consultation /telephone Resolving patient issues and needs < 16h 5. help Mobilize and coordinate available medical resources to improve the feasibility of health plans Use video push to implement health education for patients; Make a mind map to facilitate patients' understanding; Issue medication guidance cards to patients to improve compliance; Establish a patient health education group to allow patients to communicate their illness in the group and increase their confidence Face-to-face/ WeChat cloud consultation Unlimited 6. Encourage Praise patients to be engaged and motivated to persevere Give positive feedback to patients' confusion and feelings, and increase their self-management motivation; Inform the patient of the improvement of each eye examination compared with the previous one, and give the patient the confidence to adhere to the health plan; Regular online follow-up and follow-up to give patients humanistic care Face-to-face/ WeChat cloud consultation ≥ 10 min/ time 7. education Provide patients with health support in knowledge and skills According to the different needs of patients online, push different videos and articles for patients, including eye drops, storage of eye drops, blinking exercises, wet and hot compresses, disease-related knowledge, etc.; Set up a WeChat group online to collect patients' related questions and answer them in time; Directly impart relevant skills and knowledge to patients through offline model demonstrations; Establish a green channel for diagnosis and treatment of ophthalmology-rheumatology and immunology department to provide patients with multidisciplinary health support Face-to-face/ WeChat cloud consultation ≥ 20 min/ time 8. Bootstrap Stimulate patients' internal awareness and integrate health goals into their lives Through the above intervention content, the patient's information reserve and internal awareness can be increased, so that patients can develop healthy habits in daily life, complete the change of self-management behavior, and achieve the whole cycle management of patients' diseases Face-to-face/ WeChat cloud consultation/ telephone Unlimited At the level of self-management support, timely evaluation of patients' knowledge of disease self-management, and carry out comprehensive and systematic knowledge education for patients with a lack of knowledge. The emphasis should be on the practice of self-management, taking the cultivation of healthy living habits and rehabilitation management, such as eye drops, blinking exercises, and wet and hot compresses, as the intervention targets of self-management. On the basis of sufficient knowledge, patients are encouraged to take self-care, stimulate their subjective initiative, improve their self-management efficiency, and urge patients to insist on integrating healthy living habits into long-term daily life [ 40 ] . At the community level, good social support can alleviate the suffering of patients facing the disease independently, so as to adopt a positive coping style [ 41 ] . Through face-to-face visits at least once a month and the whole WeChat cloud consultation or telephone follow-up, patients can feel that there is social support in the process of treating diseases; Through face-to-face visits of about 3–5 patients each time and the establishment of WeChat patient health education group, patients with pSS who adhere to the management of this study can share knowledge, concepts and behavioral skills, so that patients can get peer support; With the help of the platform of joint diagnosis and treatment with the Department of Rheumatology and Immunology of our hospital, the difficulty and treatment cost of patients are reduced, and the disease adaptability and quality of life of patients are improved. Statistical analysis The collected questionnaires were checked by two people and entered into SPSS 27.0 statistical software for data analysis. The measurement data that conformed to the normal distribution were expressed as (x ̄ ± s). The paired t-test was used to analyze the differences in dry eye symptoms, drug tolerance, compliance, knowledge, belief, and behavior, and psychology of pSS patients in the experimental group before and after 24 weeks of CDM intervention. The difference was statistically significant with P < 0.05. No important changes were made to the trail design, outcomes, or analyses after the study commenced. Results Baseline characteristics The study collected 34 patients diagnosed with pSS. The mean age of patients was 56.62 ± 11. 98 years, of which 94.12% (32/34) of patients were female and the remaining 5.88% (2/34) of patients were male. 67.65% (23/34) of patients only used artificial tears to relieve discomfort caused by dry eyes, but 32.35% (11/34) of patients did not take any measures to deal with eye problems caused by pSS before participating in this study. According to the data recovered by the SPEED scale, 70.59% (24/34) of patients had mild dry eye symptoms, 26.47% (9/34) of patients had severe dry eye symptoms, and only 2.94% (1/34) of patients had no dry eye symptoms. According to the recovery data of the OSDI scale, 41.18% (14/34) of patients had mild ocular surface disease, 35.29% (12/34) of patients had no ocular surface disease, and 23.53% (8/34) of patients had severe ocular surface disease. According to the recovery data of the DASS-21 scale, 52.94% (18/34) of patients' psychological and emotional levels are at a normal level, and the remaining 47.06% (16/34) of patients have different degrees and aspects of psychological and emotional disorders. According to the data recovered by the visual analog scale, 32.35% (11/34) of patients had mild ocular discomfort, 47.06% (16/34) of patients had moderate ocular discomfort, and 20.59% (7/34) of patients had severe ocular discomfort. The above demographic description is shown in Table 2 and Fig. 2 . Table 2 Demographic description. Age (mean ± SD) All patients n = 34 56.62 ± 11.98 Gender (F/M) 32/2 Coping style (artificial tears/none) 23/11 Dry eye symptoms (asymptomatic/mild/severe) 1/23/10 Ocular surface disorder (asymptomatic/mild/severe) 12/14/8 Depression (normal/mild/moderate/severe) 22/7/4/1 Anxiety (normal/mild/moderate/severe/very severe) 18/3/6/2/5 Pressure (normal/mild/moderate) 27/6/1 All subjects were treated with CCM for 24 weeks of dry eye management, and questionnaires were collected at enrollment, 4 weeks ± 1 week, 12 weeks ± 1 week, and 24 weeks ± 1 week, a total of 4 times. The retention rate of this study was high, with 91.19% (31/34) of subjects completing the entire dry eye management. Compliance After CCM dry eye management, all subjects collected compliance questionnaires at 4 weeks ± 1 week, 12 weeks ± 1 week, and 24 weeks ± 1 week, respectively. The compliance questionnaires included four aspects: artificial tears, cyclosporine eye drops, blinking exercises, and wet hot compress, and adopted a four-grade score method, namely, 1 was complete non-compliance, 2 was partial non-compliance (compliance ≤ 75%), 3 was partial compliance (compliance ≥ 75%), and 4 was complete. It can be intuitively seen from Fig. 3 that after undergoing CCM dry eye management, patients' compliance with cyclosporine eye drops, blinking exercises, and wet and hot compresses ranged from 4 weeks to 24 weeks. The sex was significantly improved compared with that at the time of enrollment; After 24 weeks of CCM dry eye management, patients' compliance with artificial tears, cyclosporine eye drops, blinking exercises and wet hot compresses was in a relatively stable state from 4 weeks to 24 weeks (p > 0.05), among which the compliance of artificial tears and cyclosporine eye drops was significantly higher than that of blinking exercises and wet hot compresses. Analysis of clinical symptoms Symptoms of dry eye In this study, the SPEED scale was used to assess the severity of dry eye symptoms in subjects. Both eyes of the subjects were assessed separately at enrollment, 12 weeks, and 24 weeks. The severity of specific symptoms is shown in Fig. 3 . According to the scale score, 0 is asymptomatic, 1–9 is mild dry eye symptoms, and 10 and above is severe dry eye symptoms. It can be seen from the Fig. 4 that during the 24-week CCM dry eye management, the subject's ocular symptoms in both eyes are mild dry eye degree, and there is no significant change within 24 weeks. Ocular surface disease index In this study, the OSDI scale was used to evaluate the ocular surface disease index of subjects, and the subjects were evaluated at enrollment, 12 weeks, and 24 weeks, respectively. The specific ocular surface diseases are shown in Fig. 4 . According to the scale score, 0–20 was classified as mild symptoms, 21–45 as moderate symptoms, and 46 and above as severe symptoms. It can be seen from the Fig. 5 that the mean degree of ocular surface disease symptoms of subjects at the time of enrollment was moderate, after 12 weeks of CCM dry eye management, the mean degree of ocular surface disease of subjects decreased to mild symptoms, and after another 24 weeks of CCM dry eye management, the mean degree of ocular surface disease of subjects returned to moderate symptoms. Psychological assessment Knowledge-Attitude-Practice In this study, dry eye patients used eye drops, knowledge, attitude, and practice questionnaires to evaluate the changes in the three dimensions of subjects' practice, attitude, and knowledge during chronic disease management. The subjects were evaluated at enrollment and 24 weeks, respectively, as shown in Table 3 and Fig. 6 . Table 3 Knowledge-attitude-behavior. Knowledge manner Practice Average Standard deviation Average Standard deviation Average Standard deviation Enrollment 25.50 4.29 9.74 3.74 18.41 3.69 24 weeks 31.88 3.60 11.60 2.42 21.12 2.39 P <0.001 0.15 0.02 After 24 weeks of chronic disease management, compared with the time of enrollment, the subjects had significant differences in knowledge and behavior dimensions (p 0.05). Depression-anxiety-stress In this study, the self-rating depression-anxiety-stress scale was used to evaluate the changes of the three dimensions of depression, anxiety, and stress during chronic disease management. The subjects were evaluated at enrollment and at 24 weeks, respectively. The specific situation is shown in Table 4 and Fig. 7 . Table 4 Depression-Anxiety-Stress. depressed Anxiety pressure Average Standard deviation Average Standard deviation Average Standard deviation Enrollment 7.47 6.26 9.88 7.24 8.24 5.84 24 weeks 3.36 3.43 5.76 4.13 5.84 4.99 P 0.01 0.01 0.03 After 24 weeks of chronic disease management, compared with the time of enrollment, the subjects showed significant differences in the three dimensions of depression, anxiety, and stress (p < 0.05), among which the differences in the depression and anxiety dimensions were more significant. According to the scale score, the depression dimension 0–9 was classified as normal, 10–13 as mild depression, 14–20 as moderate depression, 21–27 as severe depression, and 28 and above as very severe depression. After 24 weeks of chronic disease management, 71.43% (5/7) of patients with mild depression improved to normal, 33.33% (1/3) of patients with moderate depression improved to mild depression, 33.33% (1/3) of patients with moderate depression improved to normal, and a total of 63.64% (7/11) of patients with depression problems improved to varying degrees. According to the scale score, the anxiety dimension 0–7 was classified as normal, 8–9 as mild anxiety, 10–14 as moderate anxiety, 15–19 as severe anxiety, and 20 and above as very severe anxiety. After 24 weeks of chronic disease management, 66.67% (2/3) of patients with mild anxiety improved to normal, 40% (2/5) of patients with moderate anxiety improved to normal, 40% (2/5) of patients with moderate anxiety improved to mild anxiety, 100% (1/1) of patients with severe anxiety improved to moderate anxiety, 40% (2/5) of patients with very severe anxiety improved to mild anxiety, and 20% (1/5) of patients with very severe anxiety improved to severe anxiety. According to the scale score, stress dimensions 0–14 were classified as normal, 15–18 as mild stress, 19–25 as moderate stress, 26–33 as severe stress, and 24 and above as very severe stress. After 24 weeks of chronic disease management, 83.33% (5/6) of patients with mild stress improved their stress status to normal. Discussion This study will discuss the selecion of CDM frameworks, the specific implementation strategies for dry eye management, and the extent of improvement in patients’ physical and psychological well-being. The selected CCM framework demonstrates clinical appropriateness for dry eye management in pSS patients In the paragraph about CDM in the Introduction, it was mentioned that utilizing systemactic bibliographic database screening, five chronic disease care models and chronic disease management models were found. Among these five models, we chose CCM as the theoretical framework of this study. Because ICIC and ICCC are extended on the basis of CCM, we first select among the three models of CCM, CDSMP, and TCM. First of all, CDSMP is a self-management model based on self-efficacy theory [ 42 ] . According to Bandura's research [ 43 ] , improving self-efficacy includes four ways: personal experience, other people's experience, verbal persuasion, and physiological and emotional state. This model is mainly to train qualified patients to carry out courses in the community to teach the knowledge and skills needed for self-management of patients with the same disease [ 44 ] , while pSS patients have complex conditions, poor treatment effects and heavy negative emotions, and this study is a hospital outpatient visit and home telephone follow-up, so CDSMP is not selected as the theoretical framework guide of this study. Secondly, TCM refers to a series of time-bound services provided during the onset of a patient's disease, across different settings, with improved outcomes in terms of patient experience, health status, and economic cost [ 45 ] . This model is suitable for nursing in the period of change of treatment environment, such as the transfer of critically ill patients from the intensive care unit to the general ward [ 46 ] , and the transition of postoperative patients from hospitalization to discharge home rehabilitation treatment [ 47 ] . However, the pSS patients in this study are not involved in the change of treatment environment, so TCM is not selected as the theoretical framework guide of this study. After that, the comparison was continued in the three models of CCM, ICIC, and ICCC. ICIC is based on CCM by adding five elements of patient safety, cultural competence, care coordination, community strategy, and case management [ 48 ] , aiming to integrate medical science with smaller health organizations; ICCC is expanded on the basis of CCM, including three levels: macro, meso, and micro. The macro level includes five nodes: legislative support and policy integration, financial support, staffing and development, inter-departmental cooperation and cooperation, and leadership and publicity [ 49 ] , one of the focuses is population. The population of pSS patients in this study was not numerically advantageous, and the study did not involve community primary care, so CCM was finally determined as the theoretical framework guide for this study. A 24-week dry eye management program based on the CCM was implemented for pSS patients. Longitudinal questionnaire assessments at enrollment, 4-week, 12-week, and 24-week intervals demonstrated significant improvements in medication adherence, KAP scores, and psychological outcomes, indicating CCM’s efficacy for dry eye management in pSS populations. Impact analysis of CCM on medication compliance, symptom severity, KAP, and psychological distress in dry eye management Compliance The compliance of patients in this study was in a relatively stable state, in which the compliance with artificial tears and cyclosporine eye drops was better on average at 24-week CCM dry eye management (≥ 75% compliance) and poor compliance with blinking exercises and wet hot compresses (≤ 75% compliance). In terms of improving patient compliance, it is mainly supported by two levels of delivery system design and self-management in the theoretical framework of CCM, so these two levels are further discussed and analyzed. First, at the level of delivery system design, the researcher selected the 8 steps of HC as the specific method of implementing the process. Among them, there are five steps closely related to compliance: observation, strengthening, clarification, help and encouragement. In the observation step, through communication with the patient, it is learned that the reason for the patient's low compliance with blinking exercise is mainly that the patient lacks belief and attitude towards it, and stops the practice by himself without good feedback after a few short attempts; However, the main reason for the low compliance of wet hot compress is that patients lack time to apply wet hot compress, and often reduce the number of wet hot compress or even don't apply wet hot compress because of their going out plan. In the intensive step, the researcher issued a medication guidance card to the patient, but the guidance card did not prompt the patient to perform blinking exercises and wet and hot compresses, which may weaken the patient's belief in developing a healthy lifestyle, resulting in high compliance without using eye drops. Therefore, in the early design, more emphasis should be placed on the importance of each item of the health plan to ensure the full implementation of the plan. In the clarification step, when it is found that the patient lacks correct understanding of blinking exercises and wet hot compresses, it should be explained and explained to the patient. In addition to offline face-to-face feedback and online WeChat cloud consultation of the patient, the frequency and time of online researchers actively asking about the patient's compliance should be increased. For example, patients with poor compliance (compliance ≤ 75%) should be asked and prompted through WeChat cloud consultation or telephone at least twice a week to ensure the correct and effective health plan. In the help and encouragement step, the patient's condition communication in the online group can be adjusted to an offline face-to-face meeting under the condition of obtaining the patient's wishes. For example, a lecture is held every 2 weeks, and patients are encouraged to ask questions, speak, and communicate in the lecture. Through the support and communication among peers, patients have the determination to adhere to the motivation of implementing the health plan. At the level of self-management support, when it is found that patients' compliance with blinking exercises and wet hot compresses is lower than that of eye drops, the intervention target should be adjusted from rehabilitation management, such as eye drops, to the cultivation of blinking exercises and wet hot compresses habits. By consulting the literature related to self-efficacy, we can find ways to stimulate patients' self-awareness and subjective initiative, so as to improve patients' self-management efficiency. Symptoms of dry eye In this study, the SPEED questionnaire and OSDI questionnaire were used to evaluate the severity of patients' dry eye symptoms. At the time of enrollment, the SPEED questionnaire and OSDI questionnaire suggested that 23.52%-29.41% of patients had severe dry eye, which was much higher than other types of dry eye, mainly related to the pathophysiological mechanism of their primary disease. The stimulation and infiltration of B cells in patients with pSS can lead to apoptosis of ductal epithelial cells of exocrine glands such as lacrimal glands and inhibit the synthesis of tear secretion proteins [ 50 ] ; In addition, in the state of persistent chronic inflammation of the patient's lacrimal gland, the glandular results are gradually replaced by fibrous tissue, which eventually leads to permanent loss of secretory function; Moreover, the density of corneal nerve fibers and the secretion of neurotrophic factors in such patients decreases, resulting in not only decreased tear secretion, but also abnormal ocular surface neuromodulation [ 51 ] , which will cause patients to further amplify subjective symptoms, such as burning sensation and foreign body sensation. At 12 weeks, the degree of dry eye symptoms suggested by the SPEED questionnaire did not improve significantly compared with before, while the symptoms of ocular surface diseases suggested by the OSDI questionnaire improved to some extent compared with before. It can be seen that although the dry eye symptoms of pSS patients cannot be significantly improved in a short time due to the primary disease, it is urgent to control the progression of ocular diseases. At 24 weeks, both the SPEED questionnaire and the OSDI questionnaire returned to levels similar to those at the time of enrollment. After the discussion, the investigators in the group agreed that this may be related to the large-scale infection of patients with Novel Coronavirus during the 12 to 24 weeks of CCM dry eye management. When the Novel Coronavirus triggers a systemic immune response, it will release a large number of inflammatory factors (such as IL-6, TNF-α, etc.). These inflammatory factors will cause damage to lacrimal gland function and destroy the stability of the ocular surface, resulting in decreased tear secretion and excessive tear film evaporation, thus aggravating the degree of dry eye symptoms. To verify this conjecture, it is necessary to extend the patient's management cycle to observe the change in the degree of dry eye symptoms after excluding the influence of Novel Coronavirus infection. Knowledge-Attitude-Practice Changes in patient knowledge, attitude, and behavior are inextricably linked to the delivery system design of CCM. The change in the knowledge dimension is most significant because patients realize the necessity and significance of change through access to information, learning, and reflection, and take the first step towards final behavior change. There are 10 items related to knowledge dimensions in the questionnaire on knowledge, attitude, and behavior of patients with dry eye using eye drops. After analyzing these 10 items, it is found that the subjects need to know their ingredients when buying eye drops, I know the correct method of eye drops, eye drops should be dropped in conjunctival sac, eye drops should be dropped in conjunctival sac, and I know the correct preservation method of eye drops. For the two items "eye drops can cause allergy or poisoning" and "eye drops can cause dependence", because the eye drops used by patients in this CCM dry eye management did not involve poisoning, and most patients had reduced complaints of dry eyes due to CCM dry eye management, and the number of artificial tears used was appropriately reduced at the doctor's suggestion, so the patient's scores in these two items did not improve significantly. For the item "You can't open your eyes immediately after eye drops", the average score of patients enrolled was 2.88 points (out of 4 points), so the improvement was not significant. For the two items "Eye drops cannot be stored at room temperature" and "Eye drops cannot be used for more than two months", because the eye drops used by patients in this CCM dry eye management are stored at room temperature, and the validity period of each eye drop ranges from 24 hours to 12 weeks according to the instructions, the score of patients in these two items is not significantly improved. In the attitude dimension, the overall improvement of patients was not significant, which may be related to the fact that there were fewer entries (4) in the questionnaire dealing with this dimension. The patient's two items, "I am very concerned about my knowledge of eye drops" and "I have actively sought knowledge about eye drops," have changed greatly, which is related to the knowledge related to the use and storage methods of eye drops learned by patients during CCM dry eye management. However, patients had little change in the two items "when using eye drops, it will have an impact if you don't drop them on time" and "it will have an impact when you forget to drop them once". The average score of the former patient enrollment was 2.84 points, so the improvement was not significant. The latter suggests that researchers should strengthen the frequency when the importance of eye drops. In the behavioral dimension, the subjects showed the most significant improvement in the item "need to wash their hands before and after eye drops". For the three items "when they feel uncomfortable in their eyes, they usually choose a regular hospital for treatment", "I will buy eye drops in a regular pharmacy" and "I don't buy eye drops from unknown sources (such as Internet/WeChat friends circle)", the average initial scores of patients enrolled in the group were 2.81, 2.56 and 2.97, so the improvement was not significant. Depression-anxiety-stress In terms of depression, anxiety, and stress, patients experienced significant improvements in all three dimensions. pSS is a rare disease with a prevalence rate of about 0.033‰-1.03‰. There is a lack of attention and management for this group of people at home and abroad. Because the disease cannot be cured, with the development of the course of the disease, the disease can gradually involve urinary, respiratory, nervous, digestive, and other systems from the initial dry mouth and eyes, and cause diseases of systemic organs. The long course of disease and bad prognosis make pSS patients have greater negative psychological emotions, and the design of CCM at the community level not only pays attention to the improvement of eye symptoms of this group of patients, but also pays attention to relieving the negative psychological emotions of patients. Limitations When distributing some scales, the time node is set for a long time, which leads to some difficulties in the process of scale recovery. The study recruited subjects from April 2022 to October 2023, and conducted chronic disease management for 24 weeks at the same time. This period is catching up with the high incidence period of Novel Coronavirus infection, which may cause dry eye symptoms in some patients. Recurrence and aggravation, but this part of the speculation still lacks data support. However, the recurrence and aggravation of dry eye symptoms may indirectly lead to other effects, such as patients' psychology and emotions. Conclusions The 24-week dry eye magagement intervention for patients with pSS, designed around core elements of the CCM and structured procedures of HC technology, has demonstrated both feasibility and acceptability. This integrated approach successfully maintained high levels of medication and behavioral adherence, significantly enhanced patients’ knowledge-attitude-practice regarding treatment, reduced psychological stress, and alleviated symptoms of anxiety and depression. Despite challenges in data collection due to the COVID-19 pandemic, most participants completed the trial, providing valuable clinical evidence for the potential value of CCM based interventions in this population. These findings underscore both the practicality and importance of implementing CCM for pSS and contribute to the development of tailored intervention strategies. Future studies should expand to more diverse populations, refine data collection methodologies to minimize attrition from uncontrollable factors, and extend follow-up duration to evaluate long-term outcomes and sustainability of intervention effects. Declarations Funding This study was funded by Beijing Bethune Charitable Foundation BJ-GY2021007J. Data Availability Statement The raw data supporting the conclusions of this article will be made available by the corresponding author to any qualified scientist for non-commercial purposes, without undue reservation. Access to the data will be granted in compliance with participant confidentiality agreements, and personal identifiers will not be disclosed. Ethics declarations This study was approved by the Biomedical Research Ethics Committee of Peking University First Hospital(Approval No.2021 Scientific Research 320) prior to study registration and data collection. Written informed consent was obtained from all participants. Each participant was informed that their participation was voluntary and that withdrawal from the study would not affect their access to outpatient care. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. Consent for publication Not applicable. 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09:27:25","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1323996,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9202023/v1/df7ad407-f0a2-4527-8b47-b5c3fdf6b0a0.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Managing Dry Eye Disease in Primary Sjögren's Syndrome with the Chronic Disease Care Model","fulltext":[{"header":"Introduction","content":"\u003cp\u003eSj\u0026ouml;gren's syndrome (SS) is a chronic, systemic autoimmune disease characterized by lymphocyte infiltration into exocrine organs, including salivary glands, lacrimal glands, and parotid glands, resulting in dry mouth and eye symptoms and parotid gland enlargement \u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e. It is divided into primary Sj\u0026ouml;gren's syndrome (pSS) and secondary Sj\u0026ouml;gren's syndrome. PSS is characterized by immune abnormalities of the innate immune system, leading to B cell stimulation, autoantibody production, and inflammation of salivary and lacrimal glands, mainly with other multiple organ involvement\u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e, with a prevalence of about 0.033\u0026permil;-1.03\u0026permil; \u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e. Dry eye is one of the most common symptoms in patients with pSS, and its incidence rate is as high as 92.71% \u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e. It is also one of the important criteria for diagnosing pSS\u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e. The symptoms of dry eye in patients with pSS are usually moderate to severe, and the clinical manifestations include eye discomfort and visual impairment such as foreign body sensation, dry eyes, itchy eyes, photophobia, or tear reduction. In severe cases, recurrent purulent infection of the eyelid margin, conjunctivitis, keratitis, and other infectious inflammation may occur, and visual loss may also occur in the late stage\u003csup\u003e[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e. In addition, pSS is not only a physiological disease, but also a challenge to the psychological level of patients\u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e. First, its chronic character and the persistence of symptoms significantly reduce the quality of life of patients. Long-term physical discomfort, such as persistent dry mouth, dry eyes, and other possible accompanying symptoms, such as joint pain, fatigue, etc., restricts the patient's daily activities. This condition tends to make patients feel helpless and depressed, thus increasing the risk of depression\u003csup\u003e[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e. Secondly, because pSS is a progressive disease, about 30% of patients can suffer from multiple organ dysfunction and severe systemic manifestations in the later stage of the disease, and these patients usually can only get treatment for one symptom at a time. For example, patients go to the ophthalmology department for treatment of dry eye, but if they want to improve the symptoms of dry mouth, they need to go to the stomatology department, and when they want to improve the symptoms of dry skin, they need to go to the dermatology department\u003csup\u003e[\u003cspan additionalcitationids=\"CR10 CR11 CR12\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e. In addition, due to the influence of the disease, patients may reduce their participation in social activities such as parties and travel. In the absence of social support and understanding, this sense of social isolation will further aggravate their negative emotions, such as depression, anxiety, and fatigue, and even autonomic dysfunction may occur in severe cases \u003csup\u003e[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]\u003c/sup\u003e. The course of pSS is long, the condition is repeated and changeable. Compared with other patients with dry eye, the symptoms are the most severe, the treatment is the most difficult, and some patients have severe negative emotions. Therefore, long-term medical monitoring and follow-up of people suffering from this disease are needed. A study from the National Institute of Medical and Nutritional Sciences of Mexico\u003csup\u003e[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e pointed out that only 67% of pSS patients received treatment for systemic symptoms, and 35.2% of them would stop taking drugs on their own due to adverse drug reactions, lack of efficacy, or poor compliance. No research on patients' eye treatment and compliance has been found. Therefore, it is of great significance to study and improve patients' compliance with eye treatment and standardize patients' dry eye management for improving patients' mood and long-term prognosis.\u003c/p\u003e \u003cp\u003eChronic disease management (CDM) is a scientific management model that provides comprehensive, continuous, and active management for patients with chronic non-communicable diseases to promote patient health, delay disease development, reduce disability rate, reduce medical expenses, and improve quality of life \u003csup\u003e[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/sup\u003e. Globally, there are no relevant research reports on systemic and ocular CDM of pSS patients, and the management of pSS patients in most countries is still in the exploratory stage. Extensive literature review indicates that a wide array of chronic disease nursing models and CDM paradigms currently exist in both national and global healthcare systems. Different models have different elements to consider. Therefore, it is necessary to review and evaluate the existing models and select the most suitable model for pSS patients to apply and evaluate its effect. Searching in PubMed, a total of 5 models were retrieved, including the Chronic Care Model (CCM), Improving Chronic Care (ICIC), Innovative Care for Chronic Conditions (ICCC), the Stanford Chronic Disease Self-Management Program (CDSMP), and the Transitional Care Model (TCM) \u003csup\u003e[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]\u003c/sup\u003e. CCM is a model of care developed by Wagner in 2002 that provides a proactive, patient-centered, evidence-based approach to promoting high-quality care for chronically ill patients. CCM includes six elements: healthcare organization, clinical information system, decision support, delivery system design, self-management support, and community. In foreign countries, CCM has been widely used in chronic diseases such as cardiovascular disease, cancer, chronic respiratory disease and diabetes, and has achieved good results in lifestyle improvement, clinical outcome improvement, patient satisfaction and disease knowledge awareness rate\u003csup\u003e[\u003cspan additionalcitationids=\"CR19 CR20 CR21 CR22 CR23 CR24 CR25\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]\u003c/sup\u003e, so CCM was finally selected as the theoretical framework guide of this study. CCM requires the participation of doctors, nurses, and patients. Doctors need to assess the severity of patients' diseases and formulate personalized treatment plans. As a bridge between doctors and patients, nurses play many important roles in the process of chronic disease management, such as communicating with patients and their families, implementing health education, long-term follow-up, observing patients' needs, and giving timely feedback\u003csup\u003e[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]\u003c/sup\u003e, etc.\u003c/p\u003e \u003cp\u003eAt present, there are few related studies on CDM in pSS patients worldwide. However, once it is incurable for life, chronic disease management is particularly important for such patients, and pSS involves multiple organs throughout the body. In the whole process of chronic disease management, it needs the participation of multidisciplinary teams to maximize the promotion of patients' physical and mental health and delay disease progression. Whether it is to establish a multidisciplinary cooperative team or develop a new medical treatment model of joint diagnosis, treatment, and care for pSS patients, we are all facing huge challenges. Therefore, we need to study the comprehensive and full-cycle management of chronic diseases for pSS patients, and explore the latest care models and methods suitable for this group of people. This study applies the CCM framework to explore its feasibility in managing dry eye in patients with pSS, including specific implementation methods, as well as its effects on the psychological foundation and practical nursing insights for CDM in pSS. On the other hand, it seeks to offer clinical reference evidence for multidisciplinary, lifelong disease management in a broader range of chronic conditions.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003eThe study is a self-controlled before-and-after trial. We calculated the sample size by G * Power 3.1, and the calculation showed that we needed 34 sample size. From April 2022 to Octeber 2023, pSS patients who were treated in the ophthalmology clinics of tertiary hospitals in Beijing were recruited, and the doctors in the chronic disease management team formulated personalized treatment plans for the patients. The patients who volunteered to participate in the 24-week follow-up of chronic disease management were collected as the study subjects, with a total of 34 study subjects at the time of enrollment. At enrollment, participants were invited to complete five questionnaires: the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire\u003csup\u003e[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]\u003c/sup\u003e, the Ocular Surface Disease Index (OSDI) questionnaire\u003csup\u003e[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]\u003c/sup\u003e, the Compliance questionnaire\u003csup\u003e[\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]\u003c/sup\u003e, the Depression, Anxiety and Stress Scale\u0026minus;21 (DASS\u0026minus;21) questionnaire\u003csup\u003e[\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]\u003c/sup\u003e, and the Knowledge, Attitudes, and Practices (KAP) regarding eye drop use questionnaire\u003csup\u003e[\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]\u003c/sup\u003e. These assessments were repeated at the 4\u003csup\u003eth\u003c/sup\u003e, 12\u003csup\u003eth\u003c/sup\u003e, and 24\u003csup\u003eth\u003c/sup\u003e weeks of the 24-week CDM program to evaluate changes from baseline across different dimensions. The detailed study flow is shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. This study is reported in accordance with the CONSORT statement for non-randomized trails.\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eParticipants\u003c/h3\u003e\n\u003cp\u003eFrom April 2022 to October 2023, patients with pSS were recruited from tertiary hospitals in Beijing. Upon enrollment, each participant was assigned a unique identification number based on their entry sequence to anonymize the data. This study was approved by the Biomedical Research Ethics Committee of Peking University First Hospital (Approval No.2021 Scientific Research 320), and written informed consent was obtained from all participants prior to inclusion.\u003c/p\u003e \u003cp\u003eInclusion criteria: (1) Meet the diagnostic criteria of pSS in the Classification Criteria for Primary Sjogren's Syndrome published by the American College of Rheumatology (ACR) and the European Alliance Against Rheumatism (EULAR) in 2016\u003csup\u003e[\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]\u003c/sup\u003e, which is based on the weighted sum of 5 items: anti-SSA/Ro antibody positivity and focal lymphocytic sialadenitis with a focus score of \u0026ge;\u0026thinsp;1 foci/4 mm\u003csup\u003e2\u003c/sup\u003e, each scoring 3; Individuals with abnormal ocular staining score\u0026thinsp;\u0026ge;\u0026thinsp;5, Schirmer test result\u0026thinsp;\u0026le;\u0026thinsp;5 mm/5 min, unstimulated saliva flow rate\u0026thinsp;\u0026le;\u0026thinsp;0. 1 ml/min, score 1 for each item, with signs and symptoms suggestive of SS and a total score\u0026thinsp;\u0026ge;\u0026thinsp;4 for the above items are diagnostic criteria for pSS; (2) Age 18\u0026ndash;65 years old; (3) The course of pSS\u0026thinsp;\u0026ge;\u0026thinsp;3 months; (4) Combined with different degrees of dry eye symptoms; (5) Be able to implement the treatment plan and follow-up as required; (6) Informed consent to voluntarily participate in this study.\u003c/p\u003e \u003cp\u003eExclusion criteria: (1) Women preparing for pregnancy, pregnant and breastfeeding; (2) Combined with fundus disease or active ocular surface disease; (3) Severe hearing and visual impairment; (4) Severe heart, brain, lung, liver, kidney and other organ damage or dysfunction; (5) Malignant tumor; (6) Unable to take care of yourself; (7) Participating in other interventional studies.\u003c/p\u003e \u003cp\u003eSubjects who meet the inclusion criteria of the experimental group are invited to participate in the study, and with their consent, the chronic disease management team will conduct an intervention for 24 weeks.\u003c/p\u003e\n\u003ch3\u003eInterventions\u003c/h3\u003e\n\u003cp\u003e Under the guidance of the CCM theoretical framework, the six elements included in it are further designed: medical care organization, clinical information system, decision support, delivery system design, self-management support, and community.\u003c/p\u003e \u003cp\u003eAt the level of the healthcare organization, a pSS management team composed of ophthalmologists and nurses from Peking University First Hospital was established. Because the symptoms of pSS in the eye are caused by lacrimal gland involvement, an attending physician from the subspecialty group of corneal and ocular surface diseases was invited to join the team and provide clinical decision-making support. Because it is necessary to carry out ophthalmic diagnosis and treatment for patients, a nurse who has obtained the certificate of ophthalmic specialist nurse of the Chinese Nursing Association is invited to join the team. Because it is necessary to implement health education, follow-up, and feedback for patients through literature research and clinical actual situation, a nurse with evidence-based medicine learning experience and more than 5 years of clinical work experience in ophthalmology was invited to join the team. Because it is necessary to supervise and control the quality of the management team, a head nurse with more than 25 years of clinical experience in ophthalmology is invited to join the team.\u003c/p\u003e \u003cp\u003eAt the level of the clinical information system, a personal file is established for each enrolled study subject. The file is discussed and designed by the management team, including the number, name, gender, age, medical history, medication, and contact telephone number. The results of each eye examination and changes in condition are also recorded in the file, and the file will prompt the patient's time of each telephone follow-up and outpatient visit to avoid loss of follow-up caused by forgetting. Personal files are kept by the management team in a unified way, and two-person verification is completed each time to avoid data loss.\u003c/p\u003e \u003cp\u003eAt the level of decision support, we can learn the latest theoretical knowledge by consulting the literature and combine the experience of clinical diagnosis and treatment to construct a feasible personalized treatment plan. Before the start of the study, the management team conducted individual studies and group discussions, and the attending physician conducted unified training and assessment of nurses. Throughout the study, the attending physician formulated the treatment plan of the study subjects and made corresponding adjustments according to the results of each examination.\u003c/p\u003e \u003cp\u003eAt the level of delivery system design, Health coaching (HC) technology is adopted as a medical process to improve the lifestyle of pSS patients. HC is the practice of health education and health promotion under the background of coaching, including eight steps: contact, observation, strengthening, clarification, help, encouragement, education, and guidance, to promote the realization of patients' goals related to personal health\u003csup\u003e[\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]\u003c/sup\u003e. At present, it has been widely used in the health education of patients with diabetes, chronic obstructive pulmonary disease, cancer, stroke, and depression, and some studies have confirmed that it has achieved positive results in patients' self-management of diseases\u003csup\u003e[\u003cspan additionalcitationids=\"CR36 CR37 CR38\" citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e]\u003c/sup\u003e. Intervene with patients through face-to-face, distribution of health education sheets and medication guidance cards, WeChat cloud consultation, and telephone communication. Follow the eight steps of HC, work out personalized and feasible plan goals with patients, make patients master the plan content by means of model demonstration and video push, and follow up with the patients for 24 weeks. The specific implementation process is shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. This study involved non-invasive CDM interventions without pre-specified safety monitoring indicators. Participation was voluntary, and participants could withdraw at any time.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eHC-specific implementation process\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eprocedure\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003etarget\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eContents\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eForm\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eTime\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Contact\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGain patient trust, establish good communication, and master patient diagnosis and treatment plan\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntroduce themselves with patients, establish their personal files, use SPEED questionnaire, OSDI questionnaire, compliance questionnaire and DASS scale to evaluate the disease degree, medication status and psychological situation of patients, provide disease guidance for patients, and make health plans together with patients\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFace-to-face\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;30 min/ time\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2. observe\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUnderstand patient awareness and health needs\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eUse the knowledge-attitude-behavior questionnaire to evaluate the cognition of patients, understand the part and reasons that patients think it is difficult to implement the health plan through verbal communication, push relevant videos, and get contact information for later observation of patients' implementation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFace-to-face\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;30 min/ time\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3. intensify\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEmphasize the importance of compliance and facilitate patient implementation of health plans\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eReduce the psychological pressure of patients who think it is difficult to implement health education through communication skills such as listening, empathy, and feedback; Help patients establish self-management and develop a healthy lifestyle by issuing medication guidance cards, telephone, or WeChat follow-up at least once a week\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFace-to-face/ WeChat cloud consultation/ telephone\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;10 min/ time\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4. Clarification\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEnsure the correctness and effectiveness of health plan implementation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eWhen it is found that patients lack a correct understanding of disease knowledge, the use of eye drops and the development of healthy habits, they should be explained and explained to patients; If patients have other related questions and needs, they should thoroughly understand the causes of their confusion and give correct and feasible health guidance in time; If the patient has a problem that cannot be solved online, the patient should be informed that he must see a doctor offline in time\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFace-to-face/ WeChat cloud consultation /telephone\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eResolving patient issues and needs\u0026thinsp;\u0026lt;\u0026thinsp;16h\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5. help\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMobilize and coordinate available medical resources to improve the feasibility of health plans\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eUse video push to implement health education for patients; Make a mind map to facilitate patients' understanding; Issue medication guidance cards to patients to improve compliance; Establish a patient health education group to allow patients to communicate their illness in the group and increase their confidence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFace-to-face/ WeChat cloud consultation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eUnlimited\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6. Encourage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePraise patients to be engaged and motivated to persevere\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGive positive feedback to patients' confusion and feelings, and increase their self-management motivation; Inform the patient of the improvement of each eye examination compared with the previous one, and give the patient the confidence to adhere to the health plan; Regular online follow-up and follow-up to give patients humanistic care\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFace-to-face/ WeChat cloud consultation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;10 min/ time\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7. education\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eProvide patients with health support in knowledge and skills\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAccording to the different needs of patients online, push different videos and articles for patients, including eye drops, storage of eye drops, blinking exercises, wet and hot compresses, disease-related knowledge, etc.; Set up a WeChat group online to collect patients' related questions and answer them in time; Directly impart relevant skills and knowledge to patients through offline model demonstrations; Establish a green channel for diagnosis and treatment of ophthalmology-rheumatology and immunology department to provide patients with multidisciplinary health support\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFace-to-face/ WeChat cloud consultation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;20 min/ time\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e8. Bootstrap\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eStimulate patients' internal awareness and integrate health goals into their lives\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eThrough the above intervention content, the patient's information reserve and internal awareness can be increased, so that patients can develop healthy habits in daily life, complete the change of self-management behavior, and achieve the whole cycle management of patients' diseases\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFace-to-face/ WeChat cloud consultation/ telephone\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eUnlimited\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAt the level of self-management support, timely evaluation of patients' knowledge of disease self-management, and carry out comprehensive and systematic knowledge education for patients with a lack of knowledge. The emphasis should be on the practice of self-management, taking the cultivation of healthy living habits and rehabilitation management, such as eye drops, blinking exercises, and wet and hot compresses, as the intervention targets of self-management. On the basis of sufficient knowledge, patients are encouraged to take self-care, stimulate their subjective initiative, improve their self-management efficiency, and urge patients to insist on integrating healthy living habits into long-term daily life \u003csup\u003e[\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAt the community level, good social support can alleviate the suffering of patients facing the disease independently, so as to adopt a positive coping style\u003csup\u003e[\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]\u003c/sup\u003e. Through face-to-face visits at least once a month and the whole WeChat cloud consultation or telephone follow-up, patients can feel that there is social support in the process of treating diseases; Through face-to-face visits of about 3\u0026ndash;5 patients each time and the establishment of WeChat patient health education group, patients with pSS who adhere to the management of this study can share knowledge, concepts and behavioral skills, so that patients can get peer support; With the help of the platform of joint diagnosis and treatment with the Department of Rheumatology and Immunology of our hospital, the difficulty and treatment cost of patients are reduced, and the disease adaptability and quality of life of patients are improved.\u003c/p\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eThe collected questionnaires were checked by two people and entered into SPSS 27.0 statistical software for data analysis. The measurement data that conformed to the normal distribution were expressed as (x ̄ \u0026plusmn; s). The paired t-test was used to analyze the differences in dry eye symptoms, drug tolerance, compliance, knowledge, belief, and behavior, and psychology of pSS patients in the experimental group before and after 24 weeks of CDM intervention. The difference was statistically significant with P\u0026thinsp;\u0026lt;\u0026thinsp;0.05. No important changes were made to the trail design, outcomes, or analyses after the study commenced.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eBaseline characteristics\u003c/h2\u003e \u003cp\u003eThe study collected 34 patients diagnosed with pSS. The mean age of patients was 56.62\u0026thinsp;\u0026plusmn;\u0026thinsp;11. 98 years, of which 94.12% (32/34) of patients were female and the remaining 5.88% (2/34) of patients were male. 67.65% (23/34) of patients only used artificial tears to relieve discomfort caused by dry eyes, but 32.35% (11/34) of patients did not take any measures to deal with eye problems caused by pSS before participating in this study. According to the data recovered by the SPEED scale, 70.59% (24/34) of patients had mild dry eye symptoms, 26.47% (9/34) of patients had severe dry eye symptoms, and only 2.94% (1/34) of patients had no dry eye symptoms. According to the recovery data of the OSDI scale, 41.18% (14/34) of patients had mild ocular surface disease, 35.29% (12/34) of patients had no ocular surface disease, and 23.53% (8/34) of patients had severe ocular surface disease. According to the recovery data of the DASS-21 scale, 52.94% (18/34) of patients' psychological and emotional levels are at a normal level, and the remaining 47.06% (16/34) of patients have different degrees and aspects of psychological and emotional disorders. According to the data recovered by the visual analog scale, 32.35% (11/34) of patients had mild ocular discomfort, 47.06% (16/34) of patients had moderate ocular discomfort, and 20.59% (7/34) of patients had severe ocular discomfort. The above demographic description is shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e and Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographic description.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eAge (mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll patients n\u0026thinsp;=\u0026thinsp;34\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e56.62\u0026thinsp;\u0026plusmn;\u0026thinsp;11.98\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGender (F/M)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e32/2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCoping style (artificial tears/none)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23/11\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDry eye symptoms (asymptomatic/mild/severe)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1/23/10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOcular surface disorder (asymptomatic/mild/severe)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12/14/8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDepression (normal/mild/moderate/severe)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22/7/4/1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnxiety (normal/mild/moderate/severe/very severe)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18/3/6/2/5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePressure (normal/mild/moderate)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e27/6/1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eAll subjects were treated with CCM for 24 weeks of dry eye management, and questionnaires were collected at enrollment, 4 weeks\u0026thinsp;\u0026plusmn;\u0026thinsp;1 week, 12 weeks\u0026thinsp;\u0026plusmn;\u0026thinsp;1 week, and 24 weeks\u0026thinsp;\u0026plusmn;\u0026thinsp;1 week, a total of 4 times. The retention rate of this study was high, with 91.19% (31/34) of subjects completing the entire dry eye management.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eCompliance\u003c/h3\u003e\n\u003cp\u003eAfter CCM dry eye management, all subjects collected compliance questionnaires at 4 weeks\u0026thinsp;\u0026plusmn;\u0026thinsp;1 week, 12 weeks\u0026thinsp;\u0026plusmn;\u0026thinsp;1 week, and 24 weeks\u0026thinsp;\u0026plusmn;\u0026thinsp;1 week, respectively. The compliance questionnaires included four aspects: artificial tears, cyclosporine eye drops, blinking exercises, and wet hot compress, and adopted a four-grade score method, namely, 1 was complete non-compliance, 2 was partial non-compliance (compliance\u0026thinsp;\u0026le;\u0026thinsp;75%), 3 was partial compliance (compliance\u0026thinsp;\u0026ge;\u0026thinsp;75%), and 4 was complete.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eIt can be intuitively seen from Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e that after undergoing CCM dry eye management, patients' compliance with cyclosporine eye drops, blinking exercises, and wet and hot compresses ranged from 4 weeks to 24 weeks. The sex was significantly improved compared with that at the time of enrollment; After 24 weeks of CCM dry eye management, patients' compliance with artificial tears, cyclosporine eye drops, blinking exercises and wet hot compresses was in a relatively stable state from 4 weeks to 24 weeks (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05), among which the compliance of artificial tears and cyclosporine eye drops was significantly higher than that of blinking exercises and wet hot compresses.\u003c/p\u003e\n\u003ch3\u003eAnalysis of clinical symptoms\u003c/h3\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eSymptoms of dry eye\u003c/h2\u003e \u003cp\u003eIn this study, the SPEED scale was used to assess the severity of dry eye symptoms in subjects. Both eyes of the subjects were assessed separately at enrollment, 12 weeks, and 24 weeks. The severity of specific symptoms is shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. According to the scale score, 0 is asymptomatic, 1\u0026ndash;9 is mild dry eye symptoms, and 10 and above is severe dry eye symptoms. It can be seen from the Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e that during the 24-week CCM dry eye management, the subject's ocular symptoms in both eyes are mild dry eye degree, and there is no significant change within 24 weeks.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eOcular surface disease index\u003c/h2\u003e \u003cp\u003eIn this study, the OSDI scale was used to evaluate the ocular surface disease index of subjects, and the subjects were evaluated at enrollment, 12 weeks, and 24 weeks, respectively. The specific ocular surface diseases are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e. According to the scale score, 0\u0026ndash;20 was classified as mild symptoms, 21\u0026ndash;45 as moderate symptoms, and 46 and above as severe symptoms. It can be seen from the Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e that the mean degree of ocular surface disease symptoms of subjects at the time of enrollment was moderate, after 12 weeks of CCM dry eye management, the mean degree of ocular surface disease of subjects decreased to mild symptoms, and after another 24 weeks of CCM dry eye management, the mean degree of ocular surface disease of subjects returned to moderate symptoms.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003ePsychological assessment\u003c/h2\u003e \u003cdiv id=\"Sec14\" class=\"Section3\"\u003e \u003ch2\u003eKnowledge-Attitude-Practice\u003c/h2\u003e \u003cp\u003eIn this study, dry eye patients used eye drops, knowledge, attitude, and practice questionnaires to evaluate the changes in the three dimensions of subjects' practice, attitude, and knowledge during chronic disease management. The subjects were evaluated at enrollment and 24 weeks, respectively, as shown in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e and Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eKnowledge-attitude-behavior.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eKnowledge\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003emanner\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003ePractice\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAverage\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eStandard deviation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAverage\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eStandard deviation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eAverage\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eStandard deviation\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEnrollment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9.74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3.74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e18.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3.69\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e24 weeks\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e31.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11.60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e21.12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2.39\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e\u0026lt;0.001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e0.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eAfter 24 weeks of chronic disease management, compared with the time of enrollment, the subjects had significant differences in knowledge and behavior dimensions (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05), among which the differences in the knowledge dimension were more significant, and the differences in the attitude dimension were not significant (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eDepression-anxiety-stress\u003c/h2\u003e \u003cp\u003eIn this study, the self-rating depression-anxiety-stress scale was used to evaluate the changes of the three dimensions of depression, anxiety, and stress during chronic disease management. The subjects were evaluated at enrollment and at 24 weeks, respectively. The specific situation is shown in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e and Fig.\u0026nbsp;\u003cspan refid=\"Fig7\" class=\"InternalRef\"\u003e7\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDepression-Anxiety-Stress.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003edepressed\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eAnxiety\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003epressure\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAverage\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eStandard deviation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAverage\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eStandard deviation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eAverage\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eStandard deviation\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEnrollment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7.47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6.26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e8.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e5.84\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e24 weeks\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5.76\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.99\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003e0.03\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eAfter 24 weeks of chronic disease management, compared with the time of enrollment, the subjects showed significant differences in the three dimensions of depression, anxiety, and stress (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05), among which the differences in the depression and anxiety dimensions were more significant.\u003c/p\u003e \u003cp\u003eAccording to the scale score, the depression dimension 0\u0026ndash;9 was classified as normal, 10\u0026ndash;13 as mild depression, 14\u0026ndash;20 as moderate depression, 21\u0026ndash;27 as severe depression, and 28 and above as very severe depression. After 24 weeks of chronic disease management, 71.43% (5/7) of patients with mild depression improved to normal, 33.33% (1/3) of patients with moderate depression improved to mild depression, 33.33% (1/3) of patients with moderate depression improved to normal, and a total of 63.64% (7/11) of patients with depression problems improved to varying degrees.\u003c/p\u003e \u003cp\u003eAccording to the scale score, the anxiety dimension 0\u0026ndash;7 was classified as normal, 8\u0026ndash;9 as mild anxiety, 10\u0026ndash;14 as moderate anxiety, 15\u0026ndash;19 as severe anxiety, and 20 and above as very severe anxiety. After 24 weeks of chronic disease management, 66.67% (2/3) of patients with mild anxiety improved to normal, 40% (2/5) of patients with moderate anxiety improved to normal, 40% (2/5) of patients with moderate anxiety improved to mild anxiety, 100% (1/1) of patients with severe anxiety improved to moderate anxiety, 40% (2/5) of patients with very severe anxiety improved to mild anxiety, and 20% (1/5) of patients with very severe anxiety improved to severe anxiety.\u003c/p\u003e \u003cp\u003eAccording to the scale score, stress dimensions 0\u0026ndash;14 were classified as normal, 15\u0026ndash;18 as mild stress, 19\u0026ndash;25 as moderate stress, 26\u0026ndash;33 as severe stress, and 24 and above as very severe stress. After 24 weeks of chronic disease management, 83.33% (5/6) of patients with mild stress improved their stress status to normal.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study will discuss the selecion of CDM frameworks, the specific implementation strategies for dry eye management, and the extent of improvement in patients\u0026rsquo; physical and psychological well-being.\u003c/p\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eThe selected CCM framework demonstrates clinical appropriateness for dry eye management in pSS patients\u003c/h2\u003e \u003cp\u003eIn the paragraph about CDM in the Introduction, it was mentioned that utilizing systemactic bibliographic database screening, five chronic disease care models and chronic disease management models were found. Among these five models, we chose CCM as the theoretical framework of this study. Because ICIC and ICCC are extended on the basis of CCM, we first select among the three models of CCM, CDSMP, and TCM.\u003c/p\u003e \u003cp\u003eFirst of all, CDSMP is a self-management model based on self-efficacy theory \u003csup\u003e[\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e]\u003c/sup\u003e. According to Bandura's research\u003csup\u003e[\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e]\u003c/sup\u003e, improving self-efficacy includes four ways: personal experience, other people's experience, verbal persuasion, and physiological and emotional state. This model is mainly to train qualified patients to carry out courses in the community to teach the knowledge and skills needed for self-management of patients with the same disease\u003csup\u003e[\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e]\u003c/sup\u003e, while pSS patients have complex conditions, poor treatment effects and heavy negative emotions, and this study is a hospital outpatient visit and home telephone follow-up, so CDSMP is not selected as the theoretical framework guide of this study.\u003c/p\u003e \u003cp\u003eSecondly, TCM refers to a series of time-bound services provided during the onset of a patient's disease, across different settings, with improved outcomes in terms of patient experience, health status, and economic cost\u003csup\u003e[\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e]\u003c/sup\u003e. This model is suitable for nursing in the period of change of treatment environment, such as the transfer of critically ill patients from the intensive care unit to the general ward\u003csup\u003e[\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e]\u003c/sup\u003e, and the transition of postoperative patients from hospitalization to discharge home rehabilitation treatment\u003csup\u003e[\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e]\u003c/sup\u003e. However, the pSS patients in this study are not involved in the change of treatment environment, so TCM is not selected as the theoretical framework guide of this study.\u003c/p\u003e \u003cp\u003eAfter that, the comparison was continued in the three models of CCM, ICIC, and ICCC. ICIC is based on CCM by adding five elements of patient safety, cultural competence, care coordination, community strategy, and case management\u003csup\u003e[\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e]\u003c/sup\u003e, aiming to integrate medical science with smaller health organizations; ICCC is expanded on the basis of CCM, including three levels: macro, meso, and micro. The macro level includes five nodes: legislative support and policy integration, financial support, staffing and development, inter-departmental cooperation and cooperation, and leadership and publicity\u003csup\u003e[\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e]\u003c/sup\u003e, one of the focuses is population. The population of pSS patients in this study was not numerically advantageous, and the study did not involve community primary care, so CCM was finally determined as the theoretical framework guide for this study.\u003c/p\u003e \u003cp\u003eA 24-week dry eye management program based on the CCM was implemented for pSS patients. Longitudinal questionnaire assessments at enrollment, 4-week, 12-week, and 24-week intervals demonstrated significant improvements in medication adherence, KAP scores, and psychological outcomes, indicating CCM\u0026rsquo;s efficacy for dry eye management in pSS populations.\u003c/p\u003e \u003cp\u003e \u003cb\u003eImpact analysis of CCM on medication compliance, symptom severity, KAP, and psychological distress in dry eye management\u003c/b\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eCompliance\u003c/h2\u003e \u003cp\u003eThe compliance of patients in this study was in a relatively stable state, in which the compliance with artificial tears and cyclosporine eye drops was better on average at 24-week CCM dry eye management (\u0026ge;\u0026thinsp;75% compliance) and poor compliance with blinking exercises and wet hot compresses (\u0026le;\u0026thinsp;75% compliance). In terms of improving patient compliance, it is mainly supported by two levels of delivery system design and self-management in the theoretical framework of CCM, so these two levels are further discussed and analyzed.\u003c/p\u003e \u003cp\u003eFirst, at the level of delivery system design, the researcher selected the 8 steps of HC as the specific method of implementing the process. Among them, there are five steps closely related to compliance: observation, strengthening, clarification, help and encouragement. In the observation step, through communication with the patient, it is learned that the reason for the patient's low compliance with blinking exercise is mainly that the patient lacks belief and attitude towards it, and stops the practice by himself without good feedback after a few short attempts; However, the main reason for the low compliance of wet hot compress is that patients lack time to apply wet hot compress, and often reduce the number of wet hot compress or even don't apply wet hot compress because of their going out plan. In the intensive step, the researcher issued a medication guidance card to the patient, but the guidance card did not prompt the patient to perform blinking exercises and wet and hot compresses, which may weaken the patient's belief in developing a healthy lifestyle, resulting in high compliance without using eye drops. Therefore, in the early design, more emphasis should be placed on the importance of each item of the health plan to ensure the full implementation of the plan. In the clarification step, when it is found that the patient lacks correct understanding of blinking exercises and wet hot compresses, it should be explained and explained to the patient. In addition to offline face-to-face feedback and online WeChat cloud consultation of the patient, the frequency and time of online researchers actively asking about the patient's compliance should be increased. For example, patients with poor compliance (compliance\u0026thinsp;\u0026le;\u0026thinsp;75%) should be asked and prompted through WeChat cloud consultation or telephone at least twice a week to ensure the correct and effective health plan. In the help and encouragement step, the patient's condition communication in the online group can be adjusted to an offline face-to-face meeting under the condition of obtaining the patient's wishes. For example, a lecture is held every 2 weeks, and patients are encouraged to ask questions, speak, and communicate in the lecture. Through the support and communication among peers, patients have the determination to adhere to the motivation of implementing the health plan.\u003c/p\u003e \u003cp\u003eAt the level of self-management support, when it is found that patients' compliance with blinking exercises and wet hot compresses is lower than that of eye drops, the intervention target should be adjusted from rehabilitation management, such as eye drops, to the cultivation of blinking exercises and wet hot compresses habits. By consulting the literature related to self-efficacy, we can find ways to stimulate patients' self-awareness and subjective initiative, so as to improve patients' self-management efficiency.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eSymptoms of dry eye\u003c/h2\u003e \u003cp\u003eIn this study, the SPEED questionnaire and OSDI questionnaire were used to evaluate the severity of patients' dry eye symptoms.\u003c/p\u003e \u003cp\u003eAt the time of enrollment, the SPEED questionnaire and OSDI questionnaire suggested that 23.52%-29.41% of patients had severe dry eye, which was much higher than other types of dry eye, mainly related to the pathophysiological mechanism of their primary disease. The stimulation and infiltration of B cells in patients with pSS can lead to apoptosis of ductal epithelial cells of exocrine glands such as lacrimal glands and inhibit the synthesis of tear secretion proteins\u003csup\u003e[\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e]\u003c/sup\u003e; In addition, in the state of persistent chronic inflammation of the patient's lacrimal gland, the glandular results are gradually replaced by fibrous tissue, which eventually leads to permanent loss of secretory function; Moreover, the density of corneal nerve fibers and the secretion of neurotrophic factors in such patients decreases, resulting in not only decreased tear secretion, but also abnormal ocular surface neuromodulation\u003csup\u003e[\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e]\u003c/sup\u003e, which will cause patients to further amplify subjective symptoms, such as burning sensation and foreign body sensation.\u003c/p\u003e \u003cp\u003eAt 12 weeks, the degree of dry eye symptoms suggested by the SPEED questionnaire did not improve significantly compared with before, while the symptoms of ocular surface diseases suggested by the OSDI questionnaire improved to some extent compared with before. It can be seen that although the dry eye symptoms of pSS patients cannot be significantly improved in a short time due to the primary disease, it is urgent to control the progression of ocular diseases.\u003c/p\u003e \u003cp\u003eAt 24 weeks, both the SPEED questionnaire and the OSDI questionnaire returned to levels similar to those at the time of enrollment. After the discussion, the investigators in the group agreed that this may be related to the large-scale infection of patients with Novel Coronavirus during the 12 to 24 weeks of CCM dry eye management. When the Novel Coronavirus triggers a systemic immune response, it will release a large number of inflammatory factors (such as IL-6, TNF-α, etc.). These inflammatory factors will cause damage to lacrimal gland function and destroy the stability of the ocular surface, resulting in decreased tear secretion and excessive tear film evaporation, thus aggravating the degree of dry eye symptoms. To verify this conjecture, it is necessary to extend the patient's management cycle to observe the change in the degree of dry eye symptoms after excluding the influence of Novel Coronavirus infection.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eKnowledge-Attitude-Practice\u003c/h2\u003e \u003cp\u003eChanges in patient knowledge, attitude, and behavior are inextricably linked to the delivery system design of CCM.\u003c/p\u003e \u003cp\u003eThe change in the knowledge dimension is most significant because patients realize the necessity and significance of change through access to information, learning, and reflection, and take the first step towards final behavior change. There are 10 items related to knowledge dimensions in the questionnaire on knowledge, attitude, and behavior of patients with dry eye using eye drops. After analyzing these 10 items, it is found that the subjects need to know their ingredients when buying eye drops, I know the correct method of eye drops, eye drops should be dropped in conjunctival sac, eye drops should be dropped in conjunctival sac, and I know the correct preservation method of eye drops. For the two items \"eye drops can cause allergy or poisoning\" and \"eye drops can cause dependence\", because the eye drops used by patients in this CCM dry eye management did not involve poisoning, and most patients had reduced complaints of dry eyes due to CCM dry eye management, and the number of artificial tears used was appropriately reduced at the doctor's suggestion, so the patient's scores in these two items did not improve significantly. For the item \"You can't open your eyes immediately after eye drops\", the average score of patients enrolled was 2.88 points (out of 4 points), so the improvement was not significant. For the two items \"Eye drops cannot be stored at room temperature\" and \"Eye drops cannot be used for more than two months\", because the eye drops used by patients in this CCM dry eye management are stored at room temperature, and the validity period of each eye drop ranges from 24 hours to 12 weeks according to the instructions, the score of patients in these two items is not significantly improved.\u003c/p\u003e \u003cp\u003eIn the attitude dimension, the overall improvement of patients was not significant, which may be related to the fact that there were fewer entries (4) in the questionnaire dealing with this dimension. The patient's two items, \"I am very concerned about my knowledge of eye drops\" and \"I have actively sought knowledge about eye drops,\" have changed greatly, which is related to the knowledge related to the use and storage methods of eye drops learned by patients during CCM dry eye management. However, patients had little change in the two items \"when using eye drops, it will have an impact if you don't drop them on time\" and \"it will have an impact when you forget to drop them once\". The average score of the former patient enrollment was 2.84 points, so the improvement was not significant. The latter suggests that researchers should strengthen the frequency when the importance of eye drops.\u003c/p\u003e \u003cp\u003eIn the behavioral dimension, the subjects showed the most significant improvement in the item \"need to wash their hands before and after eye drops\". For the three items \"when they feel uncomfortable in their eyes, they usually choose a regular hospital for treatment\", \"I will buy eye drops in a regular pharmacy\" and \"I don't buy eye drops from unknown sources (such as Internet/WeChat friends circle)\", the average initial scores of patients enrolled in the group were 2.81, 2.56 and 2.97, so the improvement was not significant.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eDepression-anxiety-stress\u003c/h2\u003e \u003cp\u003eIn terms of depression, anxiety, and stress, patients experienced significant improvements in all three dimensions. pSS is a rare disease with a prevalence rate of about 0.033\u0026permil;-1.03\u0026permil;. There is a lack of attention and management for this group of people at home and abroad. Because the disease cannot be cured, with the development of the course of the disease, the disease can gradually involve urinary, respiratory, nervous, digestive, and other systems from the initial dry mouth and eyes, and cause diseases of systemic organs. The long course of disease and bad prognosis make pSS patients have greater negative psychological emotions, and the design of CCM at the community level not only pays attention to the improvement of eye symptoms of this group of patients, but also pays attention to relieving the negative psychological emotions of patients.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eLimitations\u003c/h2\u003e \u003cp\u003eWhen distributing some scales, the time node is set for a long time, which leads to some difficulties in the process of scale recovery.\u003c/p\u003e \u003cp\u003eThe study recruited subjects from April 2022 to October 2023, and conducted chronic disease management for 24 weeks at the same time. This period is catching up with the high incidence period of Novel Coronavirus infection, which may cause dry eye symptoms in some patients. Recurrence and aggravation, but this part of the speculation still lacks data support. However, the recurrence and aggravation of dry eye symptoms may indirectly lead to other effects, such as patients' psychology and emotions.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThe 24-week dry eye magagement intervention for patients with pSS, designed around core elements of the CCM and structured procedures of HC technology, has demonstrated both feasibility and acceptability. This integrated approach successfully maintained high levels of medication and behavioral adherence, significantly enhanced patients\u0026rsquo; knowledge-attitude-practice regarding treatment, reduced psychological stress, and alleviated symptoms of anxiety and depression.\u003c/p\u003e \u003cp\u003eDespite challenges in data collection due to the COVID-19 pandemic, most participants completed the trial, providing valuable clinical evidence for the potential value of CCM based interventions in this population. These findings underscore both the practicality and importance of implementing CCM for pSS and contribute to the development of tailored intervention strategies.\u003c/p\u003e \u003cp\u003eFuture studies should expand to more diverse populations, refine data collection methodologies to minimize attrition from uncontrollable factors, and extend follow-up duration to evaluate long-term outcomes and sustainability of intervention effects.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was funded by Beijing Bethune Charitable Foundation\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBJ-GY2021007J.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe raw data supporting the conclusions of this article will be made available by the corresponding author to any qualified scientist for non-commercial purposes, without undue reservation. Access to the data will be granted in compliance with participant confidentiality agreements, and personal identifiers will not be disclosed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics declarations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Biomedical Research Ethics Committee of Peking University First Hospital(Approval No.2021 Scientific Research 320) prior to study registration and data collection. Written informed consent was obtained from all participants. Each participant was informed that their participation was voluntary and that withdrawal from the study would not affect their access to outpatient care. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable. This manuscript does not contain any identifying images or personal or clinical details of participants that would compromise anonymity. Written informed consent was obtained from all participants for participation in the study, but consent for publication of identifiable data is not applicable as no such data are presented.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eMavragani CP, Moutsopoulos HM. Sj\u0026ouml;gren's syndrome. Annu Rev Pathol. 2014;9:273\u0026ndash;85.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNocturne G, Mariette X. Advances in understanding the pathogenesis of primary Sj\u0026ouml;gren's syndrome. Nat Rev Rheumatol. 2013;9(9):544\u0026ndash;56.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIzmirly PM, Buyon JP, Wan I, Belmont HM, Sahl S, Salmon JE, Askanase A, Bathon JM, Geraldino-Pardilla L, Ali Y, Ginzler EM, Putterman C, Gordon C, Helmick CG, Parton H. 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BrJ Ophthalmol. 2021;105(3):345\u0026ndash;251.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-ophthalmology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"boph","sideBox":"Learn more about [BMC Ophthalmology](http://bmcophthalmol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/boph","title":"BMC Ophthalmology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Primary Sjögren's syndrome, dry eye, chronic disease management, chronic disease care model, health coaching techniques","lastPublishedDoi":"10.21203/rs.3.rs-9202023/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9202023/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurposes:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo study the changes in lifestyle, disease control, and psychological mood of patients with primary Sjögren's syndrome when the chronic disease nursing model is implemented for dry eye management.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA self-controlled pre-post trial. Tertiary hospitals in Beijing served as the chronic disease management units for this study. All study subjects were given chronic care dry eye management and completed 24 weeks of follow-up. The scores of SPEED questionnaire, OSDI questionnaire, VAS scale, Knowledge-Attitude-Practice questionnaire of dry eye patients using eye drops, and DASS scale were used to evaluate the changes of subjects' medication compliance, ocular symptoms, knowledge, belief and behavior of eye drops and psychology during the 24-week follow-up, and analyze the important influence of chronic disease nursing model on eye symptoms of patients with primary Sjogren's syndrome.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA total of 34 study subjects were collected in this trial, with a high retention rate. 91.19% (n = 31) of study subjects completed the 24-week follow-up. The 24-week intervention and follow-up resulted in high and stable adherence to home-based medication and self-care among participants. Significant improvements were also observed in their knowledge, and practices related to eye drop use, along with the resolution of adverse psychological emotions.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe findings indicate that dry eye management based on a chronic care model empowers patients to adopt healthy lifestyles and alleviates negative emotions, thereby contributing to improved health outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrail registration: \u003c/strong\u003eIts registration center is Chinese Clinical Trial Registry, the trial registration number is ChiCTR2500099615, and the registration date is 2025-03-26 00:00:00.\u003c/p\u003e","manuscriptTitle":"Managing Dry Eye Disease in Primary Sjögren's Syndrome with the Chronic Disease Care Model","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-04-07 09:16:50","doi":"10.21203/rs.3.rs-9202023/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2026-05-05T16:08:17+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"166159279818121954669241412536616535669","date":"2026-04-23T15:55:38+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-22T17:34:31+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"236354473264209250581556596440537620633","date":"2026-04-22T16:19:51+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-04-01T01:09:22+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-01T01:05:21+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-03-27T10:24:50+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-03-27T07:06:31+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Ophthalmology","date":"2026-03-27T06:59:13+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-ophthalmology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"boph","sideBox":"Learn more about [BMC Ophthalmology](http://bmcophthalmol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/boph","title":"BMC Ophthalmology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"88dbe105-c3dc-4dfd-a4de-2d98586ec364","owner":[],"postedDate":"April 7th, 2026","published":true,"recentEditorialEvents":[{"type":"editorInvitedReview","content":"","date":"2026-05-05T16:08:17+00:00","index":50,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-04-07T09:16:50+00:00","versionOfRecord":[],"versionCreatedAt":"2026-04-07 09:16:50","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9202023","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9202023","identity":"rs-9202023","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}