A WeChat platform program (WCPP) for full-process management of patients with cardiac valve interventional surgery based on psycho-cardiology: Protocol of a mixed-method study | 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 A WeChat platform program (WCPP) for full-process management of patients with cardiac valve interventional surgery based on psycho-cardiology: Protocol of a mixed-method study chen kehan, Ying Xu This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4023884/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 18 Oct, 2024 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background Valvular heart disease (VHD) is the third most common cardiovascular disease (CVD), which reduced patients’ quality of life, placing a burden on patients, families and health systems, even life-threatening. Psycho-cardiology was a hot topic in recent years, revealed the relationship between mental illness and heart disease. This mixed-method study aimed to evaluate the effectiveness of WCPP, which including hospital-to-home transitional care, remote intelligent monitoring and decision AIDS, to promote the physical and mental health of patients. Methods/Design: A mixed-method study was conducted in a cardiac valve interventional surgery (CVIS) center in southwest China. A total of 154 patients will receive the intervention. Patients in the intervention group will receive the WCPP, while patients in the control group will using the traditional surgical management model, both of them will be followed up at the1, 3, 6, 12 months after discharge. The primary outcome is the Chinese version of the short-form General Health Questionnaire (SF-36). Secondary outcome measures including the 6-minute Walk Test (6MWT), Modified Barthel Index (MBI), Major Adverse Cardiovascular Events (MACE), Patient satisfaction (%), Length of Hospital Stay (LOS). In addition, qualitative research was used to evaluate the psychological state and experience of patients. Discussion Our study is one of the few involving patients with CVIS and the first to use psycho-cardiology in those patients with a full-process management. The study population is mostly from southwest China with a wide range of demographic and socioeconomic characteristics. Once completed, this study will be a rich resource of information on how to use the remote full-process management platform in CVIS patients. Trial registration: ChiCTR2400081052, Registered on 21 February 2024. The trial complies with SPIRIT and CONSORT guidelines. cardiac valve interventional surgery WeChat full-process management psycho-cardiology Figures Figure 1 Figure 2 Background Valvular heart disease (VHD) is an increasing health problem, which affects about 2.5% of the population worldwide [ 1 , 2 ] . At present, there are about 209 million patients with VHD worldwide, and approximately 25 million in China [ 3 ] . It is the leading cause of cardiovascular mortality worldwide, and the resultant disease burden is expected to increase in the coming decades [ 4 ] . Cardiac valve interventional surgery (CVIS) is the transcatheter cardiac surgery to repair or replace, including transcatheter aortic valve replacement (TAVR), transcatheter aortic valve implantation (TAVI), transcatheter edge-to-edge repair (TEER), etc. Previous studies have shown that interventional treatment confirmed favorable outcomes [ 5 ] , the shorter length of stay, reduce hospital costs, achieve a better mid-term result in survival [ 6 ] . Patients after CVIS, lie on bed is usually preferred and general last for a long time, which leads to many complications such as pressure sores, hypostatic pneumonia, deep vein thrombosis, urinary tract infection, abdominal constipation and muscle atrophy [ 7 ] , introduced adverse effects on cardiopulmonary function and heavy economic burden. Both the American College of Cardiology (ACC) and the European Society of Cardiology (ESC) strongly recommend early cardiac rehabilitation to reduce mortality, readmission rate and improve the quality of life [ 1 , 8 ] . However, at present, most hospitals in China are conservative about the start time of exercise. Furthermore, many studies designed 7-days early exercise program [ 9 ] , but the length of hospital stay (LOS) of patients has been substantially shortened under the management of Enhanced Recovery after Surgery (ERAS) in recent years, the traditional program is not applicable. In addition, recent studies show that CVD are closely related to the occurrence of psychological diseases such as anxiety and depression [ 10 , 11 ] , 15–20% of the patients display severe depressive disorders [ 12 ] . In Intensive Care Unit (ICU), the prevalence rate of anxiety, depression and post-traumatic stress disorder (PTSD) is 46%, 40% and 22% [ 13 ] . Therefore, nurses should pay more attention to the psychological state of patients. "Psycho-cardiology" was first proposed by Professor Hu Dayi in 1995 [ 14 ] . It is an emerging inter-discipline which mainly explore the interaction and outcome between psychological disorders and cardiovascular diseases, which has become a growing trend for the prevention and treatment of heart diseases [ 15 ] . And mind-body interventions (MBIs) had encouraging results for patients on physiological and behavioral outcomes [ 16 ] . However, among traditional surgical management mode, it was difficult to monitor and manage patient’s condition after discharge from hospital. By using the telehealth platform of WCPP, it can make up the shortcomings, can broaden the duration and content of interventions, break the limits of time and space, maintaining close contact, and providing patients with MBIs in a full range. It improves the subjective initiative of patients to manage the disease by themself, which is crucial to the prognosis of VHD. The full-process management is a patient-centered care model that covers the whole course of care for the patient, promotes the transition from hospital to home. The whole process management enhances the continuity of care, reduces postoperative complications, and promotes the early recovery of patients. Therefore, the aim of our study is to construct and use the WCPP to provide full-process management based on the psycho-cardiology. Through actively carrying out early cardiac rehabilitation and MBTs, promote the physiological and psychological state of patients maintaining at a basically satisfactory level, that is of great significance in the secondary prevention of VHD patients. Methods The study is a mixed-method study, which used the SPIRIT reporting guidelines [ 17 ] . The design is chosen to test the feasibility of the WCPP in a Third class A hospital. The project is organized in three phases: A development phase (2025.01-2025.12), a multidisciplinary team combining doctors, nurses, rehabilitation therapist and engineering has participated in a partnership and co-creation process that resulted in development of WeChat program and collaboration procedures. Then, the test and adjustment of the WCPP will carried out. A feasibility phase (2026.01-2027.12) with randomized controlled trial (RCT) and qualitative research, where we will examine whether the WCPP intervention are feasible, acceptable and may have positive effects for patients with CVIS. Ethics The study was approved by the Ethics Committee of West China Hospital, Sichuan University, identifier: 2023–2317. Design Stage 1: construct of the We-chat program platform (WCPP) A full-process management platform for patients undergoing CVIS will be designed based on the theory of psycho-cardiology, which emphasizes the synergy of psychosomatic interventions. The platform will run on Wechat program, which is widely used in China. It can be used by loging wechat account without registration, makes the use of the platform more convenient. The WCPP is primarily constructed to promote CVIS’s full management, from preoperation, postoperation to discharge. The WCPP is being designed in collaboration with multidisciplinary team (including doctors, nurses, rehabilitation therapists, technologists with medical backgrounds). According to the theory of psycho-cardiology, intervention will including physiological and psychological. The design of the platform was based on the best evidence in the literature, then combined with the clinical work experience of the research team, and finally formed by the discussion of multidisciplinary team. The platform including 3 module (Table 1 ). Table 1 Description of the WCPP module. Preoperative module Elements Implementor Content Virtual Reality (VR) for education Nurse In order to help patients adapt to the surgical procedure, reduce anxiety and nervousness, we recorded real-simulation video that patients could experience the surgical process advanced by using VR glasses. Music mindfulness meditation Nurse Make music videos instruct patients to mediate with soothing music, beautiful natural scenery, and a gentle voice. Remote intelligent monitoring Team cooperation: Nurse Doctor IT Staff Exercise with smart bracelet, remote monitor patients’ heart rate, heart rhythm, oxygen saturation and uploaded to the platform for analysis by ChatGPT. It can also alert medical staff when patient's condition deteriorates or emergency and open a fast channel. Pre-rehabilitation Nurse therapist A video was taken to guide patients exercise before surgery. Respiratory training Nurse A video instructs patients with deep and abdominal breathing training. Advance Care Planning (ACP) Nurse A flash video called “Xing Lin Wan Yu” [ 18 ] was used to introduce ACP and guide patients to complete ACP. Postoperative Module Music mindfulness meditation Nurse Similar to preoperative. Respiratory training Nurse Similar to preoperative. ‘THLST’ exercise: Nurse The Five-step exercise is carried out in order and adjusted according to patients’ personal condition, including Turn Over (T), Hand Movement (H), Limb Movement (L), Sit by the Bed (S), Take a walk (T) and exercise Tai Chi or Yoga (including warm-up, exercise, cooling down). The plan of training was developed by patients, multi-disciplinary team based on shared decision-making. Discharge module Remote intelligent monitoring Team cooperation: Nurse Doctor IT Staff Similar to the preoperative. Early rehabilitation Nurse Building a simulated online ward, nurses ‘one to one’ guide patients to ‘THLST’ exercise. Respiratory training Nurse Similar to preoperative. Online education Doctor Nurse Send in various forms such as text, pictures, and videos in the platform. Peer support Patient Establish peer groups in WeChat to facilitate communication and sharing of experiences among patients. Decision aids Team cooperation: Nurse Therapist Doctor IT Staff a. Artificial decision aid, patients can ask questions to medical staff and get answers within 24 hours; b. ChatGPT decision aid, provide decision-making guidance for patients by using ChatGPT; c. Intelligent decision aid: collect scientific evidence and train the machine-learning model. Stage 2: implementation of the randomised controlled trial of the WCPP Setting and sample The study is being conducted at a large hospital located at Cheng Du, which is a medical center in west China, ensured the samples adequate in the study. The recruitment runs from January to December 2025. All eligible patients will be identified by a clinical coordinator in collaboration with nursing staff. Sample size calculation: G*power software was used to calculate the sample size, based on an estimated 50% effect size (moderate benefits are expected) [ 19 ] , 80% power, and a type 1error of 5%, showed that 64 participants in each group could complete the study. As we expect a 20% dropout (13 participants), 77 participants must be included in intervention and control group. If needed, the enrolment time will be extended to reach the calculated numbers of participants. Dropouts are defined as deaths, withdrawal of consent, and patients’ discontinuing questionnaire completion during the intervention period. Inclusion criteria: 1) patients undergoing CVIS in the cardiology department of our hospital; 2) patients were conscious and in stable condition; 3) Elective surgery; 4) Informed consent and voluntary participation the study. Exclusion criteria: 1) complicated with serious organic lesions and extremely unstable vital signs; 2) death or withdrawal from the study. All eligible patients will be identified by a clinical coordinator. Randomization procedure Patients are randomized automatically by use SPSS 19.0 software. The clinical coordinator ensures that patients are allocated accordingly to the group and participants are blinded with groups. Intervention Patients in the control group have access to the traditional management mode of CVIS. After admission, patients were transferred in cardiology department, CCU, operating room, and were receive the usual treatment and care (including examination, instruction, education, and communication for surgery, the preparation of skin, blood and medicine, monitor, intravenous antibiotics). The patient was fasted for 4–6 hours before/after surgery, stay in bed for 24 hours or more. After discharge, follow-up at 1, 3, 6, 12 months (Fig. 2). After research, they will also receive training on the use of the platform. Patients in the intervention group will, in addition to usual treatment and care, have access to the full-process management by using the WCPP (for an overview see Fig. 1). The use of the WCPP was guided and supervised by nurse or a research assistant to ensure quality. The full-process is initiated in outpatient clinic or emergency, covered the entire length of the hospital stay and continued up to one year after the patient was discharged, follow-up at 1, 3, 6, 12 months (Fig. 2). Data collection Quantitative data were collected through the ‘Wenjuan Xing’ Questionnaire platform and Test, kept in the ResMan Research manager, which only members of the research group have access. Demographic and clinical characteristics Demographic characteristics collected at enrolment include age, gender, education, marital status, occupational state, family income, medical insurance, ways of living, residence were collected from a self-designed questionnaire. Patients also self-report the presence of multiple cardiovascular and non-cardiovascular comorbidities through a digital questionnaire at enrolment. Primary outcome The Chinese version of the short-form General Health Questionnaire (SF-36): is an international universal scale that is suitable for measuring the quality of life of patients. It has the advantages of brevity, flexibility, high reliability, validity and sensitivity. It has 36 items and 8 dimensions (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health), each dimension contains 2–10 items, each item had 3–5 different levels of options, and was given a corresponding score. According to the scoring rules of the scale, the total score was summed up, so as to comprehensively evaluate the physical and mental health. In addition, these eight dimensions formed two different comprehensive measures, the Physical Composite Measure (PCS) and the Mental Composite Measure (MCS). The Cronbach’α of the scale was 0.863, and the Cronbach’α of each dimension was greater than 0.75 [ 20 ] Secondary outcomes 6-minute Walk Test (6MWT): was used to compare the change of 6-minute walk distance between the two groups within 4 hours before the patients were discharged. Modified Barthel Index (MBI): was used to evaluate the (Activities of Daily Living, ADL) at admission, discharge and 1,3, 6, 12 months after discharge. Major Adverse Cardiovascular Events (MACE): including myocardial infarction, severe chest pain, stroke, heart failure, etc. Patient Satisfaction (%): A self-designed scale was used to measure the satisfaction of patients and their caregivers. Length of Hospital Stay (LOS): The length of stay (days) of the patient. Qualitative data on patient experiences Qualitative data were obtained through one-on-one interviews in a quiet office.The research team conducts qualitative semi-structured interviews with patients to uncover their psychological states, experience of the overall process, contact with health care professionals, patient’s satisfaction with WCPP, and intersectoral coordination. Patients will be selected based on criteria for maximum variation. Both patients with high and low levels of participation will be selected for interviews, recorded and transcribed in a WCPP storage database accessible only to members of the research group. Statistical analysis SPSS 19.0 software was used to analyze the data. Descriptive data will be analyzed as means with standard deviations, medians with interquartile ranges, or frequencies with percentages, depending on the distribution of variables. Differences in outcomes between the intervention and control groups will be analyzed (test level α = 0.05). All data from interviews will be audio-recorded and trascribe verbatim within 24h. Data analysis and data collection were conducted simultaneously. Traditional content analysis method was used and carried out by 2 researchers. Researchers repeatedly read the interview materials and immersed themselves in the materials to generate a sense of integrity. After that, the important ideas and concepts in the data were marked and began open coding. Similar and related codes were then grouped into categories and subcategories. Discussion With the development of ERAS, the LOS of patients after CVIS has been greatly shortened, contribute to the reform of intervention, meaning that the traditional 7 days-rehabilitation program after surgery is no longer suitable for clinical [ 9 ] , patients are more likely to faster recover and discharged. The progress of the traditional project was limited by time and place, lack of continuity, the intervention based on WCPP can carry out continuous intervention from hospital to home, complete the whole process management of patients. Interventions to improve the care transition progress (Transitional Care Program and Transitional Care Program) have been shown to prevent readmissions of CVD [ 21 ] , however, face-to-face interaction is costly and difficult to sustain in the current hospital.The remote online intervention based on WeChat can enable nurses to serve more patients at the same time, improve the efficiency, will be a cost-effective substitute for in-person transition coaches. It is a transitional-care program exist to ease the transition from the hospital to the home and to provide needed education and support for people living with CVD, to avoid rehospitalizations and other adverse outcomes [ 22 ] . Previous studies have found that psychiatric disorders are associated with the occurrence of CVD, and may be the cause of some CVDs, positive psychological factors play a pivotal role in improving cardiovascular outcomes [ 23 , 24 ] . Therefore, our research based on the idea of psycho-cardiology, implementing mind-body interventions, which actively guides patients to carry out early rehabilitation activities, combined with music mindfulness meditation, respiratory training, ACP to help patients promotes mental health and adherence to healthy behaviors, improves cardiovascular outcomes. Patients undergoing elective CVIS often have anxiety and stress symptoms caused by surgery, may lead to the increase of preoperative blood pressure, which is detrimental to surgical procedures and increase the risk of complications [ 25 ] . Therefore, we recorded real-simulation video through scenario simulation, to let patients simulation experience the surgical procedure advanced, so as to reduce preoperative and intraoperative tension and will be more adaption to the surgical process. ChatGPT has become a hot research topic of at present. In our platform, we will connect the ChatGPT interface to monitor and analysis patient’s condition collected by using wearable devices and sensors in real time before admission and after discharge, which is important to ensure the safety of patients in exercise [ 26 ] . At the same time, by using ChatGPT can provide decision-making guidance, interaction for patients, this will greatly reduce medical cost and improve clinical outcomes. In previous studies, the early exercise program starts on the 1–2 days for patients after Percutaneous Coronary Intervention (PCI) surgery [ 9 ] . Our study emphasizes the importance of pre-rehabilitation, that is a comprehensive adjuvant treatment that optimizes the patient's physiological and psychological state before surgery, optimizes the process of their physiological reserve to make them adapt to and withstand surgical stress, and achieve the best preoperative functional state, so that patients can return to their daily work and life faster after surgery. Studies found that 63% of hospitalized patients preferred not be subjected to CPR unless there was an opportunity for a complete functional recovery and 70.37% of medical staff are often involved in CPR attempts in which the efforts made are disproportionate compared to the patients’ expected prognosis, in terms of survival or quality of life [ 27 ] . In the end of life, ineffective cardiopulmonary resuscitation (CPR), defibrillation and other resuscitation waste a large amount of medical resources. Therefore, in this study, we can ues the platform to help patients establish ACP before surgery and in the stable stage of disease, so as to avoid the waste of medical resources [ 28 ] . The study has other strengths. As the largest CVIS center in Southwest China, our hospital is able to enroll a larger number of patients. The intervention length of this study were longer than most studies for full-process management of surgery, and the patients were followed up to one year after discharge. Such a large-scale and continuous study is of great significance. At the same time, this study faces several challenges. Despite our best efforts to recruit a sample of sample after CVIS, our study may still have limited generalitabilities. Our study was a single-center study, and may be that more than 95% of our enrolled patients were Chinese (may be a small number of foreigners admission in our hospital). This study is a randomized controlled trial to improve the prognosis of patients undergoing CVIS, and to achieve the full-process management of patients undergoing CVIS surgery. Combining psychological intervention with early exercise, remote monitoring with artificial intelligence can improve the prognosis of patients undergoing CVIS. Once completed, it will become an important research resource for understanding how psycho-cardiology can be used to improve outcomes of patients. Trial status At the time of manuscirpt submission, the study is in preparation. Version number: V1.0. Recruitment date: from January 1, 2026 to June 30, 2026. Declarations Competing interests The authors declare that they have no competing interests. Author contributions Kehan Chen: Conceptualization, Methodology, Software, Formal analysis, Data Curation, Writing - Original Draft. Ying Xu: Conceptualization, Writing - Review & Editing, Supervision, Project administration. 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Supplementary Files SPIRITchecklist.docx Cite Share Download PDF Status: Published Journal Publication published 18 Oct, 2024 Read the published version in Trials → Version 1 posted Editorial decision: Minor revision 01 Aug, 2024 Reviewers agreed at journal 26 May, 2024 Reviewers invited by journal 07 May, 2024 Editor assigned by journal 17 Apr, 2024 First submitted to journal 10 Apr, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4023884","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":299715651,"identity":"96a9beb3-c13f-4c85-8d6d-303f9056053a","order_by":0,"name":"chen kehan","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6ElEQVRIie3QMWvCQBTA8SsHNx1exxeU+BUuBDL5Ye4QblLomEFogmKGtrj6MTI6PjnIdN0dHFIK3bO5KHZXkrg53G9+f3jvEeJ5T4iN93ndXC6hEMt9rdJFdzIAaqMtwzjYVlNZu6o7CYGZIWeoS5wlwc+K9lhs+BlLzo8vJWKS6owRUXyo9mTkohrgjwY2Mwe9GxFw32V7QmaxlJKyAWJ10I4RCfPOJAGlKCeo1296TXskYAwgWnjFKSP9Em5tlGdG/j+ZgnIV77xlXOT57zmbvG/EpmlO6SIUxVd7coM/Nu55nufddQUDoE8R625MywAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0003-4874-2962","institution":"West China Hospital of Sichuan University","correspondingAuthor":true,"prefix":"","firstName":"chen","middleName":"","lastName":"kehan","suffix":""},{"id":299715652,"identity":"e9581d1e-31cf-49dc-9169-5480a469c6e9","order_by":1,"name":"Ying Xu","email":"","orcid":"","institution":"West China Hospital of Sichuan University","correspondingAuthor":false,"prefix":"","firstName":"Ying","middleName":"","lastName":"Xu","suffix":""}],"badges":[],"createdAt":"2024-03-07 09:52:34","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4023884/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4023884/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-024-08553-4","type":"published","date":"2024-10-18T15:57:29+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":56676941,"identity":"ae46e801-b6b5-4208-8910-2b1e22ac8de7","added_by":"auto","created_at":"2024-05-17 16:31:20","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":47346,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version.\u003c/p\u003e","description":"","filename":"Fig.1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4023884/v1/aad32f5d52fab3dc0ef5ba9e.jpg"},{"id":56676942,"identity":"8e0936f3-f02c-4499-97ea-c1fce5d23e43","added_by":"auto","created_at":"2024-05-17 16:31:21","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":127741,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend.\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4023884/v1/84c5ca060e5d1fa74e30bcf0.jpg"},{"id":67148965,"identity":"2943ad00-5864-4d97-9dce-1c2d16736506","added_by":"auto","created_at":"2024-10-21 16:10:25","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":607137,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4023884/v1/531ef2e8-01ee-491c-9908-d58065d8a4c8.pdf"},{"id":56676943,"identity":"6725d529-678a-4919-a4d1-a1588f36b0f1","added_by":"auto","created_at":"2024-05-17 16:31:21","extension":"docx","order_by":6,"title":"","display":"","copyAsset":false,"role":"supplement","size":37527,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITchecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-4023884/v1/f99fbaad87b312d9e9ddcb2a.docx"}],"financialInterests":"","formattedTitle":"A WeChat platform program (WCPP) for full-process management of patients with cardiac valve interventional surgery based on psycho-cardiology: Protocol of a mixed-method study","fulltext":[{"header":"Background","content":"\u003cp\u003eValvular heart disease (VHD) is an increasing health problem, which affects about 2.5% of the population worldwide\u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e. At present, there are about 209\u0026nbsp;million patients with VHD worldwide, and approximately 25\u0026nbsp;million in China\u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e. It is the leading cause of cardiovascular mortality worldwide, and the resultant disease burden is expected to increase in the coming decades\u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e. Cardiac valve interventional surgery (CVIS) is the transcatheter cardiac surgery to repair or replace, including transcatheter aortic valve replacement (TAVR), transcatheter aortic valve implantation (TAVI), transcatheter edge-to-edge repair (TEER), etc. Previous studies have shown that interventional treatment confirmed favorable outcomes\u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e, the shorter length of stay, reduce hospital costs, achieve a better mid-term result in survival\u003csup\u003e[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003ePatients after CVIS, lie on bed is usually preferred and general last for a long time, which leads to many complications such as pressure sores, hypostatic pneumonia, deep vein thrombosis, urinary tract infection, abdominal constipation and muscle atrophy\u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e, introduced adverse effects on cardiopulmonary function and heavy economic burden. Both the American College of Cardiology (ACC) and the European Society of Cardiology (ESC) strongly recommend early cardiac rehabilitation to reduce mortality, readmission rate and improve the quality of life\u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e. However, at present, most hospitals in China are conservative about the start time of exercise. Furthermore, many studies designed 7-days early exercise program\u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e, but the length of hospital stay (LOS) of patients has been substantially shortened under the management of Enhanced Recovery after Surgery (ERAS) in recent years, the traditional program is not applicable.\u003c/p\u003e \u003cp\u003eIn addition, recent studies show that CVD are closely related to the occurrence of psychological diseases such as anxiety and depression\u003csup\u003e[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e, 15\u0026ndash;20% of the patients display severe depressive disorders\u003csup\u003e[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e. In Intensive Care Unit (ICU), the prevalence rate of anxiety, depression and post-traumatic stress disorder (PTSD) is 46%, 40% and 22%\u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e. Therefore, nurses should pay more attention to the psychological state of patients. \"Psycho-cardiology\" was first proposed by Professor Hu Dayi in 1995\u003csup\u003e[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]\u003c/sup\u003e. It is an emerging inter-discipline which mainly explore the interaction and outcome between psychological disorders and cardiovascular diseases, which has become a growing trend for the prevention and treatment of heart diseases\u003csup\u003e[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e. And mind-body interventions (MBIs) had encouraging results for patients on physiological and behavioral outcomes\u003csup\u003e[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eHowever, among traditional surgical management mode, it was difficult to monitor and manage patient\u0026rsquo;s condition after discharge from hospital. By using the telehealth platform of WCPP, it can make up the shortcomings, can broaden the duration and content of interventions, break the limits of time and space, maintaining close contact, and providing patients with MBIs in a full range. It improves the subjective initiative of patients to manage the disease by themself, which is crucial to the prognosis of VHD. The full-process management is a patient-centered care model that covers the whole course of care for the patient, promotes the transition from hospital to home. The whole process management enhances the continuity of care, reduces postoperative complications, and promotes the early recovery of patients.\u003c/p\u003e \u003cp\u003eTherefore, the aim of our study is to construct and use the WCPP to provide full-process management based on the psycho-cardiology. Through actively carrying out early cardiac rehabilitation and MBTs, promote the physiological and psychological state of patients maintaining at a basically satisfactory level, that is of great significance in the secondary prevention of VHD patients.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThe study is a mixed-method study, which used the SPIRIT reporting guidelines\u003csup\u003e[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]\u003c/sup\u003e. The design is chosen to test the feasibility of the WCPP in a Third class A hospital. The project is organized in three phases:\u003c/p\u003e \u003cp\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e A development phase (2025.01-2025.12), a multidisciplinary team combining doctors, nurses, rehabilitation therapist and engineering has participated in a partnership and co-creation process that resulted in development of WeChat program and collaboration procedures. Then, the test and adjustment of the WCPP will carried out.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eA feasibility phase (2026.01-2027.12) with randomized controlled trial (RCT) and qualitative research, where we will examine whether the WCPP intervention are feasible, acceptable and may have positive effects for patients with CVIS.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eEthics\u003c/h2\u003e \u003cp\u003e The study was approved by the Ethics Committee of West China Hospital, Sichuan University, identifier: 2023\u0026ndash;2317.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eDesign\u003c/h2\u003e \u003cdiv id=\"Sec5\" class=\"Section3\"\u003e \u003ch2\u003eStage 1: construct of the We-chat program platform (WCPP)\u003c/h2\u003e \u003cp\u003eA full-process management platform for patients undergoing CVIS will be designed based on the theory of psycho-cardiology, which emphasizes the synergy of psychosomatic interventions. The platform will run on Wechat program, which is widely used in China. It can be used by loging wechat account without registration, makes the use of the platform more convenient. The WCPP is primarily constructed to promote CVIS\u0026rsquo;s full management, from preoperation, postoperation to discharge.\u003c/p\u003e \u003cp\u003eThe WCPP is being designed in collaboration with multidisciplinary team (including doctors, nurses, rehabilitation therapists, technologists with medical backgrounds). According to the theory of psycho-cardiology, intervention will including physiological and psychological. The design of the platform was based on the best evidence in the literature, then combined with the clinical work experience of the research team, and finally formed by the discussion of multidisciplinary team. The platform including 3 module (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDescription of the WCPP module.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003ePreoperative module\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eElements\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eImplementor\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eContent\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVirtual Reality (VR) for education\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eNurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eIn order to help patients adapt to the surgical procedure, reduce anxiety and nervousness, we recorded real-simulation video that patients could experience the surgical process advanced by using VR glasses.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMusic mindfulness meditation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eNurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMake music videos instruct patients to mediate with soothing music, beautiful natural scenery, and a gentle voice.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRemote intelligent monitoring\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eTeam cooperation:\u003c/p\u003e \u003cp\u003eNurse\u003c/p\u003e \u003cp\u003eDoctor\u003c/p\u003e \u003cp\u003eIT Staff\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eExercise with smart bracelet, remote monitor patients\u0026rsquo; heart rate, heart rhythm, oxygen saturation and uploaded to the platform for analysis by ChatGPT. It can also alert medical staff when patient's condition deteriorates or emergency and open a fast channel.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePre-rehabilitation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eNurse\u003c/p\u003e \u003cp\u003etherapist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eA video was taken to guide patients exercise before surgery.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRespiratory training\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eNurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eA video instructs patients with deep and abdominal breathing training.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdvance Care Planning (ACP)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eNurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eA flash video called \u0026ldquo;Xing Lin Wan Yu\u0026rdquo; \u003csup\u003e[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e was used to introduce ACP and guide patients to complete ACP.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003ePostoperative Module\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMusic mindfulness meditation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eSimilar to preoperative.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRespiratory training\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eSimilar to preoperative.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026lsquo;THLST\u0026rsquo; exercise:\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eThe Five-step exercise is carried out in order and adjusted according to patients\u0026rsquo; personal condition, including Turn Over (T), Hand Movement (H), Limb Movement (L), Sit by the Bed (S), Take a walk (T) and exercise Tai Chi or Yoga (including warm-up, exercise, cooling down). The plan of training was developed by patients, multi-disciplinary team based on shared decision-making.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eDischarge module\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRemote intelligent monitoring\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTeam cooperation:\u003c/p\u003e \u003cp\u003eNurse\u003c/p\u003e \u003cp\u003eDoctor\u003c/p\u003e \u003cp\u003eIT Staff\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eSimilar to the preoperative.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEarly rehabilitation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eBuilding a simulated online ward, nurses \u0026lsquo;one to one\u0026rsquo; guide patients to \u0026lsquo;THLST\u0026rsquo; exercise.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRespiratory training\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eSimilar to preoperative.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOnline education\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDoctor\u003c/p\u003e \u003cp\u003eNurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eSend in various forms such as text, pictures, and videos in the platform.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePeer support\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePatient\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eEstablish peer groups in WeChat to facilitate communication and sharing of experiences among patients.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDecision aids\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTeam cooperation:\u003c/p\u003e \u003cp\u003eNurse\u003c/p\u003e \u003cp\u003eTherapist\u003c/p\u003e \u003cp\u003eDoctor\u003c/p\u003e \u003cp\u003eIT Staff\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003ea. Artificial decision aid, patients can ask questions to medical staff and get answers within 24 hours; b. ChatGPT decision aid, provide decision-making guidance for patients by using ChatGPT; c. Intelligent decision aid: collect scientific evidence and train the machine-learning model.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStage 2: implementation of the randomised controlled trial of the WCPP\u003c/h2\u003e \u003cdiv id=\"Sec7\" class=\"Section3\"\u003e \u003ch2\u003eSetting and sample\u003c/h2\u003e \u003cp\u003eThe study is being conducted at a large hospital located at Cheng Du, which is a medical center in west China, ensured the samples adequate in the study. The recruitment runs from January to December 2025. All eligible patients will be identified by a clinical coordinator in collaboration with nursing staff.\u003c/p\u003e \u003cp\u003eSample size calculation: G*power software was used to calculate the sample size, based on an estimated 50% effect size (moderate benefits are expected)\u003csup\u003e[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/sup\u003e, 80% power, and a type 1error of 5%, showed that 64 participants in each group could complete the study. As we expect a 20% dropout (13 participants), 77 participants must be included in intervention and control group.\u003c/p\u003e \u003cp\u003eIf needed, the enrolment time will be extended to reach the calculated numbers of participants. Dropouts are defined as deaths, withdrawal of consent, and patients\u0026rsquo; discontinuing questionnaire completion during the intervention period.\u003c/p\u003e \u003cp\u003eInclusion criteria: 1) patients undergoing CVIS in the cardiology department of our hospital; 2) patients were conscious and in stable condition; 3) Elective surgery; 4) Informed consent and voluntary participation the study.\u003c/p\u003e \u003cp\u003eExclusion criteria: 1) complicated with serious organic lesions and extremely unstable vital signs; 2) death or withdrawal from the study. All eligible patients will be identified by a clinical coordinator.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eRandomization procedure\u003c/h2\u003e \u003cp\u003ePatients are randomized automatically by use SPSS 19.0 software. The clinical coordinator ensures that patients are allocated accordingly to the group and participants are blinded with groups.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eIntervention\u003c/h2\u003e \u003cp\u003e \u003cb\u003ePatients in the control group\u003c/b\u003e have access to the traditional management mode of CVIS. After admission, patients were transferred in cardiology department, CCU, operating room, and were receive the usual treatment and care (including examination, instruction, education, and communication for surgery, the preparation of skin, blood and medicine, monitor, intravenous antibiotics). The patient was fasted for 4\u0026ndash;6 hours before/after surgery, stay in bed for 24 hours or more. After discharge, follow-up at 1, 3, 6, 12 months (Fig.\u0026nbsp;2). After research, they will also receive training on the use of the platform.\u003c/p\u003e \u003cp\u003e \u003cb\u003ePatients in the intervention group\u003c/b\u003e will, in addition to usual treatment and care, have access to the full-process management by using the WCPP (for an overview see Fig.\u0026nbsp;1). The use of the WCPP was guided and supervised by nurse or a research assistant to ensure quality. The full-process is initiated in outpatient clinic or emergency, covered the entire length of the hospital stay and continued up to one year after the patient was discharged, follow-up at 1, 3, 6, 12 months (Fig.\u0026nbsp;2).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eQuantitative data were collected through the \u0026lsquo;Wenjuan Xing\u0026rsquo; Questionnaire platform and Test, kept in the ResMan Research manager, which only members of the research group have access.\u003c/p\u003e \u003cp\u003eDemographic and clinical characteristics\u003c/p\u003e \u003cp\u003eDemographic characteristics collected at enrolment include age, gender, education, marital status, occupational state, family income, medical insurance, ways of living, residence were collected from a self-designed questionnaire. Patients also self-report the presence of multiple cardiovascular and non-cardiovascular comorbidities through a digital questionnaire at enrolment.\u003c/p\u003e \u003cp\u003ePrimary outcome\u003c/p\u003e \u003cp\u003eThe Chinese version of the short-form General Health Questionnaire (SF-36): is an international universal scale that is suitable for measuring the quality of life of patients. It has the advantages of brevity, flexibility, high reliability, validity and sensitivity. It has 36 items and 8 dimensions (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health), each dimension contains 2\u0026ndash;10 items, each item had 3\u0026ndash;5 different levels of options, and was given a corresponding score. According to the scoring rules of the scale, the total score was summed up, so as to comprehensively evaluate the physical and mental health. In addition, these eight dimensions formed two different comprehensive measures, the Physical Composite Measure (PCS) and the Mental Composite Measure (MCS). The Cronbach\u0026rsquo;α of the scale was 0.863, and the Cronbach\u0026rsquo;α of each dimension was greater than 0.75\u003csup\u003e[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eSecondary outcomes\u003c/p\u003e \u003cp\u003e6-minute Walk Test (6MWT): was used to compare the change of 6-minute walk distance between the two groups within 4 hours before the patients were discharged.\u003c/p\u003e \u003cp\u003eModified Barthel Index (MBI): was used to evaluate the (Activities of Daily Living, ADL) at admission, discharge and 1,3, 6, 12 months after discharge.\u003c/p\u003e \u003cp\u003eMajor Adverse Cardiovascular Events (MACE): including myocardial infarction, severe chest pain, stroke, heart failure, etc.\u003c/p\u003e \u003cp\u003e Patient Satisfaction (%): A self-designed scale was used to measure the satisfaction of patients and their caregivers.\u003c/p\u003e \u003cp\u003eLength of Hospital Stay (LOS): The length of stay (days) of the patient.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eQualitative data on patient experiences\u003c/h2\u003e \u003cp\u003e Qualitative data were obtained through one-on-one interviews in a quiet office.The research team conducts qualitative semi-structured interviews with patients to uncover their psychological states, experience of the overall process, contact with health care professionals, patient\u0026rsquo;s satisfaction with WCPP, and intersectoral coordination. Patients will be selected based on criteria for maximum variation. Both patients with high and low levels of participation will be selected for interviews, recorded and transcribed in a WCPP storage database accessible only to members of the research group.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eSPSS 19.0 software was used to analyze the data. Descriptive data will be analyzed as means with standard deviations, medians with interquartile ranges, or frequencies with percentages, depending on the distribution of variables. Differences in outcomes between the intervention and control groups will be analyzed (test level α\u0026thinsp;=\u0026thinsp;0.05).\u003c/p\u003e \u003cp\u003eAll data from interviews will be audio-recorded and trascribe verbatim within 24h. Data analysis and data collection were conducted simultaneously. Traditional content analysis method was used and carried out by 2 researchers. Researchers repeatedly read the interview materials and immersed themselves in the materials to generate a sense of integrity. After that, the important ideas and concepts in the data were marked and began open coding. Similar and related codes were then grouped into categories and subcategories.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eWith the development of ERAS, the LOS of patients after CVIS has been greatly shortened, contribute to the reform of intervention, meaning that the traditional 7 days-rehabilitation program after surgery is no longer suitable for clinical\u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e, patients are more likely to faster recover and discharged. The progress of the traditional project was limited by time and place, lack of continuity, the intervention based on WCPP can carry out continuous intervention from hospital to home, complete the whole process management of patients.\u003c/p\u003e \u003cp\u003eInterventions to improve the care transition progress (Transitional Care Program and Transitional Care Program) have been shown to prevent readmissions of CVD\u003csup\u003e[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]\u003c/sup\u003e, however, face-to-face interaction is costly and difficult to sustain in the current hospital.The remote online intervention based on WeChat can enable nurses to serve more patients at the same time, improve the efficiency, will be a cost-effective substitute for in-person transition coaches. It is a transitional-care program exist to ease the transition from the hospital to the home and to provide needed education and support for people living with CVD, to avoid rehospitalizations and other adverse outcomes\u003csup\u003e[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003ePrevious studies have found that psychiatric disorders are associated with the occurrence of CVD, and may be the cause of some CVDs, positive psychological factors play a pivotal role in improving cardiovascular outcomes\u003csup\u003e[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/sup\u003e. Therefore, our research based on the idea of psycho-cardiology, implementing mind-body interventions, which actively guides patients to carry out early rehabilitation activities, combined with music mindfulness meditation, respiratory training, ACP to help patients promotes mental health and adherence to healthy behaviors, improves cardiovascular outcomes.\u003c/p\u003e \u003cp\u003ePatients undergoing elective CVIS often have anxiety and stress symptoms caused by surgery, may lead to the increase of preoperative blood pressure, which is detrimental to surgical procedures and increase the risk of complications\u003csup\u003e[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]\u003c/sup\u003e. Therefore, we recorded real-simulation video through scenario simulation, to let patients simulation experience the surgical procedure advanced, so as to reduce preoperative and intraoperative tension and will be more adaption to the surgical process.\u003c/p\u003e \u003cp\u003eChatGPT has become a hot research topic of at present. In our platform, we will connect the ChatGPT interface to monitor and analysis patient\u0026rsquo;s condition collected by using wearable devices and sensors in real time before admission and after discharge, which is important to ensure the safety of patients in exercise\u003csup\u003e[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]\u003c/sup\u003e. At the same time, by using ChatGPT can provide decision-making guidance, interaction for patients, this will greatly reduce medical cost and improve clinical outcomes.\u003c/p\u003e \u003cp\u003eIn previous studies, the early exercise program starts on the 1\u0026ndash;2 days for patients after Percutaneous Coronary Intervention (PCI) surgery\u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e. Our study emphasizes the importance of pre-rehabilitation, that is a comprehensive adjuvant treatment that optimizes the patient's physiological and psychological state before surgery, optimizes the process of their physiological reserve to make them adapt to and withstand surgical stress, and achieve the best preoperative functional state, so that patients can return to their daily work and life faster after surgery.\u003c/p\u003e \u003cp\u003eStudies found that 63% of hospitalized patients preferred not be subjected to CPR unless there was an opportunity for a complete functional recovery and 70.37% of medical staff are often involved in CPR attempts in which the efforts made are disproportionate compared to the patients\u0026rsquo; expected prognosis, in terms of survival or quality of life\u003csup\u003e[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]\u003c/sup\u003e. In the end of life, ineffective cardiopulmonary resuscitation (CPR), defibrillation and other resuscitation waste a large amount of medical resources. Therefore, in this study, we can ues the platform to help patients establish ACP before surgery and in the stable stage of disease, so as to avoid the waste of medical resources\u003csup\u003e[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe study has other strengths. As the largest CVIS center in Southwest China, our hospital is able to enroll a larger number of patients. The intervention length of this study were longer than most studies for full-process management of surgery, and the patients were followed up to one year after discharge. Such a large-scale and continuous study is of great significance.\u003c/p\u003e \u003cp\u003eAt the same time, this study faces several challenges. Despite our best efforts to recruit a sample of sample after CVIS, our study may still have limited generalitabilities. Our study was a single-center study, and may be that more than 95% of our enrolled patients were Chinese (may be a small number of foreigners admission in our hospital).\u003c/p\u003e \u003cp\u003eThis study is a randomized controlled trial to improve the prognosis of patients undergoing CVIS, and to achieve the full-process management of patients undergoing CVIS surgery. Combining psychological intervention with early exercise, remote monitoring with artificial intelligence can improve the prognosis of patients undergoing CVIS. Once completed, it will become an important research resource for understanding how psycho-cardiology can be used to improve outcomes of patients.\u003c/p\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eTrial status\u003c/h2\u003e \u003cp\u003eAt the time of manuscirpt submission, the study is in preparation. Version number: V1.0. Recruitment date: from January 1, 2026 to June 30, 2026.\u003c/p\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eKehan Chen: Conceptualization, Methodology, Software, Formal analysis, Data Curation, Writing - Original Draft.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eYing Xu: Conceptualization, Writing - Review \u0026amp; Editing, Supervision, Project administration.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFounding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWest China Hospital, Sichuan University, Clinical New Technology Project Consent, \u0026nbsp;2024-017.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eOtto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines[J]. Circulation. 2021;143(5):e35\u0026ndash;71.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAccorsi T, a D, Paix\u0026atilde;o MR, Souza J\u0026uacute;nior JL, et al. Valvular Heart Disease Emergencies: A Comprehensive Review Focusing on the Initial Approach in the Emergency Department[J]. Arq Bras Cardiol. 2023;120(5):e20220707.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAluru JS, Barsouk A, Saginala K, et al. Valvular Heart Disease Epidemiology[J] Med Sci (Basel). 2022;10(2):32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAluru JS, Barsouk A, Saginala K et al. Valvular Heart Disease Epidemiology[J] Med Sci (Basel), 2022, 10(2).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAvvedimento M, Tang GHL. Transcatheter aortic valve replacement (TAVR): Recent updates[J]. Prog Cardiovasc Dis. 2021;69:73\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePu JZ, Wu WH, Ke YT, et al. [Comparison of interventional and surgical treatment of paravalvular leak after cardiac valve replacement][J]. Zhonghua Yi Xue Za Zhi. 2021;101(16):1160\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBrower RG. Consequences of bed rest[J]. Crit Care Med. 2009;37(10 Suppl):S422\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePiepoli MF, Hoes AW, Agewall S et al. [2016 European guidelines on cardiovascular disease prevention in clinical practice. The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts. Developed with the special contribution of the European Association for Cardiovascular Prevention \u0026amp; Rehabilitation][J]. G Ital Cardiol (Rome), 2017, 18(7):547\u0026ndash;612.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGu Yuqing LQ, Wu J. To systematically review the effect of early ambulation in patients with acute myocardial infarction after percutaneous coronary intervention.[J]. Chin J Nurs. 2020;55(10):1571\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXue Y, Liu G, Geng Q. Associations of cardiovascular disease and depression with memory related disease: A Chinese national prospective cohort study[J]. J Affect Disord. 2020;260:11\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchmitz C, Wedeg\u0026auml;rtner SM, Langheim E, et al. Heart-Focused Anxiety Affects Behavioral Cardiac Risk Factors and Quality of Life: A Follow-Up Study Using a Psycho-Cardiological Rehabilitation Concept[J]. Front Psychiatry. 2022;13:836750.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTigges-Limmer K, Sitzer M, Gummert J. Perioperative Psychological Interventions in Heart Surgery\u0026ndash;Opportunities and Clinical Benefit[J]. Dtsch Arztebl Int. 2021;118(19):339\u0026ndash;45.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHatch R, Young D, Barber V, et al. Anxiety, Depression and Post Traumatic Stress Disorder after critical illness: a UK-wide prospective cohort study[J]. Crit Care. 2018;22(1):310.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDayi Hu. Y X. Psycho-Cardiology[M]. Psycho-Cardiology, 2008.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLevine GN. Psychological Stress and Heart Disease: Fact or Folklore?[J]. Am J Med. 2022;135(6):688\u0026ndash;96.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSuksatan W, Tankumpuan T. Mind-Body Interventions in Patients With Heart Failure: State of the Science[J]. J Appl Gerontol. 2022;41(4):1232\u0026ndash;43.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChan AW, Tetzlaff JM, G\u0026oslash;tzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials[J]. BMJ. 2013;346:e7586.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeng R, Zhang J, Chen L, et al. The effectiveness of a modified advance care planning programme[J]. Nurs Ethics. 2020;27(7):1569\u0026ndash;86.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChen Yajuan ZJ, Han F. Line double heart medical mode of nursing intervention on the impact of PCI in elderly patients with coronary heart disease.[J]. Qilu J Nurs. 2023;29(15):123\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWu Jing-Shen YX-Y, Wang Y, Gui-Yi J. He Jian-Qing. To compare the application of the short form health survey and the World Health Organization Quality of Life instrument short form in evaluating the quality of life of patients with pulmonary tuberculosis.[J]. West China Med. 2016;31(03):463\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLu YZ, Huang CW, Koyama S, et al. Dementia and readmission risk in patients with heart failure participating in a transitional care program[J]. Arch Gerontol Geriatr. 2023;110:104973.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eButler J, Petrie MC, Bains M, et al. Challenges and opportunities for increasing patient involvement in heart failure self-care programs and self-care in the post-hospital discharge period[J]. Res Involv Engagem. 2023;9(1):23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSui X, Liu T, Liang Y, et al. Psychiatric disorders and cardiovascular diseases: A mendelian randomization study[J]. Heliyon. 2023;9(10):e20754.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang X, Song C. The impact of gratitude interventions on patients with cardiovascular disease: a systematic review[J]. Front Psychol. 2023;14:1243598.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eQi H, Wen FY, Xie YY, et al. Associations between depressive, anxiety, stress symptoms and elevated blood pressure: Findings from the CHCN-BTH cohort study and a two-sample Mendelian randomization analysis[J]. J Affect Disord. 2023;341:176\u0026ndash;84.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eW\u0026oacute;jcik S, Rulkiewicz A, Pruszczyk P et al. Beyond ChatGPT: What does GPT-4 add to healthcare? The dawn of a new era[J]. Cardiol J, 2023.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNedelea PL, Corlade-Andrei M, Kantor C et al. Impact of Cardiopulmonary Resuscitation on Emergency Medical Staff-Romanian Perspective (IRESUS-EMS)[J]. J Clin Med, 2022, 11(19).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSuresh S, Au A, Mohan S, et al. Advance care and resuscitation plans in a tertiary hospital: a multimodal approach[J]. BMJ Support Palliat Care; 2023.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"cardiac valve, interventional surgery, WeChat, full-process management, psycho-cardiology","lastPublishedDoi":"10.21203/rs.3.rs-4023884/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4023884/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground\u003c/b\u003e\u003c/p\u003e \u003cp\u003eValvular heart disease (VHD) is the third most common cardiovascular disease (CVD), which reduced patients\u0026rsquo; quality of life, placing a burden on patients, families and health systems, even life-threatening. Psycho-cardiology was a hot topic in recent years, revealed the relationship between mental illness and heart disease. This mixed-method study aimed to evaluate the effectiveness of WCPP, which including hospital-to-home transitional care, remote intelligent monitoring and decision AIDS, to promote the physical and mental health of patients.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods/Design:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eA mixed-method study was conducted in a cardiac valve interventional surgery (CVIS) center in southwest China. A total of 154 patients will receive the intervention. Patients in the intervention group will receive the WCPP, while patients in the control group will using the traditional surgical management model, both of them will be followed up at the1, 3, 6, 12 months after discharge. The primary outcome is the Chinese version of the short-form General Health Questionnaire (SF-36). Secondary outcome measures including the 6-minute Walk Test (6MWT), Modified Barthel Index (MBI), Major Adverse Cardiovascular Events (MACE), Patient satisfaction (%), Length of Hospital Stay (LOS). In addition, qualitative research was used to evaluate the psychological state and experience of patients.\u003c/p\u003e\u003cp\u003e\u003cb\u003eDiscussion\u003c/b\u003e\u003c/p\u003e \u003cp\u003eOur study is one of the few involving patients with CVIS and the first to use psycho-cardiology in those patients with a full-process management. The study population is mostly from southwest China with a wide range of demographic and socioeconomic characteristics. Once completed, this study will be a rich resource of information on how to use the remote full-process management platform in CVIS patients.\u003c/p\u003e\u003cp\u003e\u003cb\u003eTrial registration:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eChiCTR2400081052, Registered on 21 February 2024. The trial complies with SPIRIT and CONSORT guidelines.\u003c/p\u003e","manuscriptTitle":"A WeChat platform program (WCPP) for full-process management of patients with cardiac valve interventional surgery based on psycho-cardiology: Protocol of a mixed-method study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-05-17 16:31:16","doi":"10.21203/rs.3.rs-4023884/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Minor revision","date":"2024-08-01T15:47:57+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2024-05-26T05:14:36+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-05-07T12:30:49+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-04-17T10:37:30+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2024-04-10T04:22:30+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
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