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IRCT20250927067378N1 IRCT 2025-10-13 Esfahan University of Medical Sciences App-Based Cardiac Rehabilitation With Gamification or Peer Support in PCI Patients Evaluating the effectiveness of Community-Based Cardiac Rehabilitation via an app with Gamification or Peer Support features on self-management and disease risk factors in PCI Patients: A Randomized Clinical Trial 2026-02-20 anticipated 258 Recruiting https://irct.ir/trial/86475 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After obtaining the ethical approval code from the Ethics Committee of Isfahan University of Medical Sciences, 258 eligible patient records of individuals who had undergone PCI will be randomly selected. A list of patient file numbers will be prepared in an Excel sheet, and 258 numbers will be chosen using a randomization formula based on a list of random numbers. Subsequently, two trained members of the research team will contact the patients, explain the importance of cardiac rehabilitation and the nature of the study, and invite them to participate. If they agree, they will be scheduled for a visit at the Cardiac Rehabilitation Center of the Cardiovascular Research Institute in Isfahan to complete demographic data, medical history, and provide written informed consent. It should be noted that if any selected patient does not meet the inclusion criteria or declines to participate after being contacted, the case will be removed from the list and replaced with another eligible sample. Afterward, the patients will be randomly allocated in equal proportions (1:1:1) to one of the three study groups using block randomization with a block size of three. م. N/A Condition 1: Coronary Artery Disease, post-Percutaneous Coronary Intervention (PCI). Condition 2: Ischemic Heart Disease. Condition 3: Cardiac Rehabilitation. Intervention 1: Application-Based Intervention Group (Gamification Group): After the initial contact, patients are invited to the cardiac rehabilitation center to complete baseline information and medical history, receive further explanations about the study, and provide written informed consent. Once all participants have completed their initial visit and baseline data have been collected, the research team will randomly assign them to one of three groups according to the described method. Participants will then be contacted again and scheduled for a follow-up in-person visit. During this session, questionnaires will be completed by two trained research team members. In addition, required tests and laboratory assessments will be performed. A sports medicine specialist will determine each patient’s maximum heart rate and exercise intensity, while a nutritionist will provide a tailored dietary plan. Based on the group assignment, participants will either receive educational video clips or be guided to access the mobile application. Interventions in the Study Groups In accordance with standard components of cardiac rehabilitation, the research team will prepare short educational videos on the following topics: Understanding cardiovascular disease, warning signs, and treatment Nutritional principles for cardiac patients Smoking cessation and tobacco use management Self-management skills, including medication adherence, decision-making, and problem-solving Managing psychological issues such as stress, depression, and disease acceptance Principles of physical activity and home-based exercise for ischemic heart disease patients These videos will be the same for all three groups. Application-based groups: The same educational videos provided to the control group will be uploaded to the app. However, in these groups, physical activity training will be delivered as an interactive exercise program, including step-by-step guided movements, a stopwatch, and short instructional clips. Patients will progress through exercises interactively with the app, completing each movement with repetitions counted by the timer before moving to the next one. This contrasts with the control group, which only views exercise demonstration clips. Additionally, in all application-based intervention groups, the app includes features for recording medical information, medications, upcoming appointments, and results of home monitoring for comorbidities (such as blood pressure and blood glucose). Patients receive reminders through notifications to enter these data and regularly measure and record their blood pressure or blood sugar (if they have hypertension or diabetes). The information is stored in the form of an electronic personal health record. Furthermore, daily notifications are sent to encourage patients to perform exercises, watch educational videos, and take their medications on time. In Gamification Group, participants will use an application redesigned with gamification features in addition to the general functions described above. Gamification here does not mean designing a game, but rather using game-related elements to increase motivation and adherence. These elements include points, badges, leaderboards, and progress tracking to enhance engagement and encourage physical activity and lifestyle changes. Moreover, in the educational and exercise sections, patients can post questions as comments and receive responses from support staff. This group also includes a habit tracker, symptom tracker, and reminder notifications to reinforce progress. Habit tracking: Patients can build motivation to adopt healthy habits and break unhealthy ones. For example, they can record daily avoidance of adding salt at the table or refraining from eating sweets. Each successful day strengthens their “progress chain,” and the app sends reminders to help maintain consistency. This chain motivates patients to preserve their progress and avoid breaking it. Symptom tracking: Patients can record symptoms (e.g., the timing and duration of angina). This allows monitoring of disease progression and worsening, and patients can share their records with their physician. Points and league features: Patients earn points (in the form of stars) for daily completion of exercises, viewing educational videos, recording and monitoring symptoms, or using the habit tracker. These points are visible to other participants, and patients are ranked in different leagues based on their scores. This feature creates a sense of competition that further motivates patients to adhere to self-management behaviors. Intervention 2: Application-Based Intervention Group (Peer Support Group): After the initial contact, patients are invited to the cardiac rehabilitation center to complete baseline information and medical history, receive further explanations about the study, and provide written informed consent. Once all participants have completed their initial visit and baseline data have been collected, the research team will randomly assign them to one of three groups according to the described method. Participants will then be contacted again and scheduled for a follow-up in-person visit. During this session, questionnaires will be completed by two trained research team members. In addition, required tests and laboratory assessments will be performed. A sports medicine specialist will determine each patient’s maximum heart rate and exercise intensity, while a nutritionist will provide a tailored dietary plan. Based on the group assignment, participants will either receive educational video clips or be guided to access the mobile application. Interventions in the Study Groups In accordance with standard components of cardiac rehabilitation, the research team will prepare short educational videos on the following topics: Understanding cardiovascular disease, warning signs, and treatment Nutritional principles for cardiac patients Smoking cessation and tobacco use management Self-management skills, including medication adherence, decision-making, and problem-solving Managing psychological issues such as stress, depression, and disease acceptance Principles of physical activity and home-based exercise for ischemic heart disease patients These videos will be the same for all three groups. Application-based groups: The same educational videos provided to the control group will be uploaded to the app. However, in these groups, physical activity training will be delivered as an interactive exercise program, including step-by-step guided movements, a stopwatch, and short instructional clips. Patients will progress through exercises interactively with the app, completing each movement with repetitions counted by the timer before moving to the next one. This contrasts with the control group, which only views exercise demonstration clips. Additionally, in all application-based intervention groups, the app includes features for recording medical information, medications, upcoming appointments, and results of home monitoring for comorbidities (such as blood pressure and blood glucose). Patients receive reminders through notifications to enter these data and regularly measure and record their blood pressure or blood sugar (if they have hypertension or diabetes). The information is stored in the form of an electronic personal health record. Furthermore, daily notifications are sent to encourage patients to perform exercises, watch educational videos, and take their medications on time. Participants in this group use an application that, in addition to the general features of an app-based intervention, has been redesigned with a peer support component. Peer support means the opportunity to interact and exchange ideas with patients who have had similar experiences.Participants in this group will have access to the in-app social network feature, which enables interaction, experience sharing, and receiving encouragement from peers who have undergone similar situations. Within this social network, each user can add other users as new friends (self-management companions). Users can view their companions’ self-management status and activities, as well as send reminder messages to them.In addition, activities that friends perform in the context of self-management (such as completing exercise sessions, engaging in educational tasks, etc.) are shared as posts, allowing peers to encourage and support one another through comments and likes. Moreover, a virtual group (chat room) tailored to the participants’ age and medical condition, and supervised by the medical support team, is created to facilitate conversations among peers.This connection with peers and observing their companionship in self-management helps foster motivation, while preventing feelings of loneliness or rejection in patients. Based on previous studies, such features are expected to contribute to the improvement of self-management.It is worth noting that in the app-based rehabilitation groups, data on patients’ activity within the app are extracted during the first week and then every two weeks, in order to monitor patient status and adherence to app usage. If any issues or lack of adherence are identified, the patient will be contacted. The purpose of this is to retain participants in the study; no new information is collected during these contacts, and these procedures are not considered study variables. Intervention 3: Control group:Participants in this group will receive only the standard cardiac rehabilitation educational videos. These videos, developed by the research team based on the standard components of cardiac rehabilitation, cover topics such as understanding heart disease, warning signs and treatment, dietary recommendations for cardiac patients, smoking cessation and management, self-management skills (including medication adherence, decision-making, and problem-solving), psychological aspects such as stress and depression management, and safe home-based physical activity and exercise.The same educational videos will be provided to all study groups; however, participants in the control group will receive them via CD or a one-time file transfer through social media, based on their preference. They will not have access to the cardiac rehabilitation mobile application or its features (gamification or peer-support).During the first week and subsequently every two weeks, a brief follow-up phone call will be made to check the participants’ status and encourage them to continue watching and practicing the educational materials. These calls are solely intended to maintain motivation and adherence and do not involve data collection. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Individual participant data (IPD) will not be shared publicly due to ethical and legal concerns regarding patient privacy and confidentiality. The dataset contains sensitive health information that could potentially lead to re-identification of participants even after de-identification procedures. Moreover, current national regulations and institutional ethical policies restrict the transfer of patient-level data to external parties without explicit consent and ethics approval. However, aggregated data and summarized results of the study will be available upon reasonable request and may be shared with qualified researchers after approval by the corresponding ethics committee and the principal investigator.
public Dr. Ehsan Shirvani
Interventional Cardiology Research Center, Isfahan Cardiovascular Research Institute, Shahid Rahmani Alley, Moshtagh Sevom St., Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8158388994 +98 31 3611 5213 shirvani_xs100@yahoo.com Esfahan University of Medical Sciences scientific Dr. Masoumeh Sadeghi
Isfahan Cardiovascular Research Center, Cardiac Rehabilitation Research Center, Shaheed Chamran Educational and Treatment Complex, Rahmani Alley, after Pol-e Shahrestan, Moshtagh 3rd Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8158388994 +98 31 3611 5209 sadeghimasoumeh@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 40 and 65 years Patients diagnosed with coronary artery disease who have undergone PCI and have been discharged from Chamran Hospital within two weeks prior to enrollment. Patients identified as low-risk by a cardiologist, eligible for home-based rehabilitation, and unwilling to participate in center-based programs. Possession of and ability to use a smartphone and the study application. Willingness to provide written informed consent and comply with the study protocol. 40 years 65 years Both Patients with contraindications for exercise (such as untreated ventricular tachycardia, severe heart failure, left ventricular ejection fraction >45%, uncontrolled hypertension, or cognitive impairments preventing exercise). Inability to use the application due to physical or technological limitations. Concurrent participation in other clinical trials. I25.10 I25.9 Z51.89 Atherosclerotic heart disease of native coronary artery without angina pectoris Chronic ischemic heart disease, unspecified Encounter for other specified aftercare Lifestyle Lifestyle Lifestyle Application-Based Intervention Group (Gamification Group): After the initial contact, patients are invited to the cardiac rehabilitation center to complete baseline information and medical history, receive further explanations about the study, and provide written informed consent. Once all participants have completed their initial visit and baseline data have been collected, the research team will randomly assign them to one of three groups according to the described method. Participants will then be contacted again and scheduled for a follow-up in-person visit. During this session, questionnaires will be completed by two trained research team members. In addition, required tests and laboratory assessments will be performed. A sports medicine specialist will determine each patient’s maximum heart rate and exercise intensity, while a nutritionist will provide a tailored dietary plan. Based on the group assignment, participants will either receive educational video clips or be guided to access the mobile application. Interventions in the Study Groups In accordance with standard components of cardiac rehabilitation, the research team will prepare short educational videos on the following topics: Understanding cardiovascular disease, warning signs, and treatment Nutritional principles for cardiac patients Smoking cessation and tobacco use management Self-management skills, including medication adherence, decision-making, and problem-solving Managing psychological issues such as stress, depression, and disease acceptance Principles of physical activity and home-based exercise for ischemic heart disease patients These videos will be the same for all three groups. Application-based groups: The same educational videos provided to the control group will be uploaded to the app. However, in these groups, physical activity training will be delivered as an interactive exercise program, including step-by-step guided movements, a stopwatch, and short instructional clips. Patients will progress through exercises interactively with the app, completing each movement with repetitions counted by the timer before moving to the next one. This contrasts with the control group, which only views exercise demonstration clips. Additionally, in all application-based intervention groups, the app includes features for recording medical information, medications, upcoming appointments, and results of home monitoring for comorbidities (such as blood pressure and blood glucose). Patients receive reminders through notifications to enter these data and regularly measure and record their blood pressure or blood sugar (if they have hypertension or diabetes). The information is stored in the form of an electronic personal health record. Furthermore, daily notifications are sent to encourage patients to perform exercises, watch educational videos, and take their medications on time. In Gamification Group, participants will use an application redesigned with gamification features in addition to the general functions described above. Gamification here does not mean designing a game, but rather using game-related elements to increase motivation and adherence. These elements include points, badges, leaderboards, and progress tracking to enhance engagement and encourage physical activity and lifestyle changes. Moreover, in the educational and exercise sections, patients can post questions as comments and receive responses from support staff. This group also includes a habit tracker, symptom tracker, and reminder notifications to reinforce progress. Habit tracking: Patients can build motivation to adopt healthy habits and break unhealthy ones. For example, they can record daily avoidance of adding salt at the table or refraining from eating sweets. Each successful day strengthens their “progress chain,” and the app sends reminders to help maintain consistency. This chain motivates patients to preserve their progress and avoid breaking it. Symptom tracking: Patients can record symptoms (e.g., the timing and duration of angina). This allows monitoring of disease progression and worsening, and patients can share their records with their physician. Points and league features: Patients earn points (in the form of stars) for daily completion of exercises, viewing educational videos, recording and monitoring symptoms, or using the habit tracker. These points are visible to other participants, and patients are ranked in different leagues based on their scores. This feature creates a sense of competition that further motivates patients to adhere to self-management behaviors. Application-Based Intervention Group (Peer Support Group): After the initial contact, patients are invited to the cardiac rehabilitation center to complete baseline information and medical history, receive further explanations about the study, and provide written informed consent. Once all participants have completed their initial visit and baseline data have been collected, the research team will randomly assign them to one of three groups according to the described method. Participants will then be contacted again and scheduled for a follow-up in-person visit. During this session, questionnaires will be completed by two trained research team members. In addition, required tests and laboratory assessments will be performed. A sports medicine specialist will determine each patient’s maximum heart rate and exercise intensity, while a nutritionist will provide a tailored dietary plan. Based on the group assignment, participants will either receive educational video clips or be guided to access the mobile application. Interventions in the Study Groups In accordance with standard components of cardiac rehabilitation, the research team will prepare short educational videos on the following topics: Understanding cardiovascular disease, warning signs, and treatment Nutritional principles for cardiac patients Smoking cessation and tobacco use management Self-management skills, including medication adherence, decision-making, and problem-solving Managing psychological issues such as stress, depression, and disease acceptance Principles of physical activity and home-based exercise for ischemic heart disease patients These videos will be the same for all three groups. Application-based groups: The same educational videos provided to the control group will be uploaded to the app. However, in these groups, physical activity training will be delivered as an interactive exercise program, including step-by-step guided movements, a stopwatch, and short instructional clips. Patients will progress through exercises interactively with the app, completing each movement with repetitions counted by the timer before moving to the next one. This contrasts with the control group, which only views exercise demonstration clips. Additionally, in all application-based intervention groups, the app includes features for recording medical information, medications, upcoming appointments, and results of home monitoring for comorbidities (such as blood pressure and blood glucose). Patients receive reminders through notifications to enter these data and regularly measure and record their blood pressure or blood sugar (if they have hypertension or diabetes). The information is stored in the form of an electronic personal health record. Furthermore, daily notifications are sent to encourage patients to perform exercises, watch educational videos, and take their medications on time. Participants in this group use an application that, in addition to the general features of an app-based intervention, has been redesigned with a peer support component. Peer support means the opportunity to interact and exchange ideas with patients who have had similar experiences.Participants in this group will have access to the in-app social network feature, which enables interaction, experience sharing, and receiving encouragement from peers who have undergone similar situations. Within this social network, each user can add other users as new friends (self-management companions). Users can view their companions’ self-management status and activities, as well as send reminder messages to them.In addition, activities that friends perform in the context of self-management (such as completing exercise sessions, engaging in educational tasks, etc.) are shared as posts, allowing peers to encourage and support one another through comments and likes. Moreover, a virtual group (chat room) tailored to the participants’ age and medical condition, and supervised by the medical support team, is created to facilitate conversations among peers.This connection with peers and observing their companionship in self-management helps foster motivation, while preventing feelings of loneliness or rejection in patients. Based on previous studies, such features are expected to contribute to the improvement of self-management.It is worth noting that in the app-based rehabilitation groups, data on patients’ activity within the app are extracted during the first week and then every two weeks, in order to monitor patient status and adherence to app usage. If any issues or lack of adherence are identified, the patient will be contacted. The purpose of this is to retain participants in the study; no new information is collected during these contacts, and these procedures are not considered study variables. Control group:Participants in this group will receive only the standard cardiac rehabilitation educational videos. These videos, developed by the research team based on the standard components of cardiac rehabilitation, cover topics such as understanding heart disease, warning signs and treatment, dietary recommendations for cardiac patients, smoking cessation and management, self-management skills (including medication adherence, decision-making, and problem-solving), psychological aspects such as stress and depression management, and safe home-based physical activity and exercise.The same educational videos will be provided to all study groups; however, participants in the control group will receive them via CD or a one-time file transfer through social media, based on their preference. They will not have access to the cardiac rehabilitation mobile application or its features (gamification or peer-support).During the first week and subsequently every two weeks, a brief follow-up phone call will be made to check the participants’ status and encourage them to continue watching and practicing the educational materials. These calls are solely intended to maintain motivation and adherence and do not involve data collection. Patients' knowledge, attitude, and practice towards self-management of heart disease. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: Knowledge, Attitude and Performance Questionnaire (CVD KAP 29 Checklist). Patients' quality of life score. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: SF-36 questionnaire. Physical activity score of patients. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: International Physical Activity Questionnaire-short form: IPAQ- short form. Patients' depression scores. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: Patient Health Questionnaire-4. Patients' anxiety scores. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: Patient Health Questionnaire-4. Patients' medication adherence score. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: General Medication Adherence Scale (GMAS). Total cholesterol level. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: In the laboratory using a diagnostic kit. Patients' fasting blood sugar levels. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: In the laboratory using a diagnostic kit. The HDL blood level of patients. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: In the laboratory using a diagnostic kit. The LDL blood level of patients. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: In the laboratory using a diagnostic kit. Patients' blood triglyceride levels. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: In the laboratory using a diagnostic kit. Blood pressure levels in patients. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: A standard blood pressure monitor. Patients' 6-minute walk test score (exercise and functional capacity). Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: The distance covered in 6 minutes by the patients, under the supervision of two trained nurses. Body mass index level of patients. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: The patients' height and weight are calculated and recorded by two specialist nurses using a digital scale and a standard height gauge, without shoes and wearing light clothing. Waist circumference of patients. Timepoint: Before the start of the intervention and 6 months after the start of the intervention. Method of measurement: Using a standard meter by two specialist nurses. Nutritional status of patients. Timepoint: Before the start of the intervention and six months after the start of the intervention. Method of measurement: Using the nutritional checklist used in the SIB system and primary health care centers. Number of cigarettes smoked daily by patients. Timepoint: Before the start of the intervention and six months after the start of the intervention. Method of measurement: Number of cigarettes smoked by patients in a day. Esfahan University of Medical Sciences Approved 2025-08-13 Isfahan University of Medical Sciences – Alzahra Research Centers Complex (Research Ethics Committee Hezar Jarib St., Central Headquarters, Isfahan University of Medical Sciences and Health Services, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)