- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289815
Construction and Application of an Intelligent Collaborative Cardiac Rehabilitation App for Middle-aged and Young Patients With Myocardial Infarction
December 4, 2025 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Construction and Application of an Intelligent Collaborative Cardiac Rehabilitation Management Model for Young and Middle-aged Patients With Myocardial Infarction Based on Intervention Mapping
This study is guided by the intervention mapping theory, combined with Fogg's behavior model and digital health technologies, focusing on the key rehabilitation obstacles and behavioral characteristics of young and middle-aged MI patients.
It constructs a "smart + collaborative" out-of-hospital rehabilitation management model.
This model, through systematic needs assessment and problem logical modeling [11], develops individualized rehabilitation paths covering multiple dimensions of intervention such as exercise, diet, medication, and psychological regulation.
It relies on digital means such as mobile terminals, online education, behavior check-ins, real-time feedback, and remote follow-ups to achieve intelligent rehabilitation management.
At the same time, it emphasizes the multi-disciplinary collaboration mechanism, integrating team members from cardiology, nursing, nutrition, rehabilitation, and psychology, forming a collaborative work system with information sharing, task complementarity, and consistent goals.
Together, they promote the activation of patient motivation, improvement of behavioral ability, and improvement of rehabilitation compliance.
The study will also verify its feasibility and initial effects in a real clinical environment, and evaluate its practical value in improving rehabilitation behaviors, promoting functional recovery, and enhancing quality of life.
This study not only innovatively integrates intervention mapping and behavioral science models into the rehabilitation management of young and middle-aged MI patients in theory, filling the gap in existing rehabilitation models for this group, but also explores the path of digital rehabilitation intervention that can be promoted and replicated in grassroots clinical practice.
The research results can provide practical basis for the construction of the smart rehabilitation service system under the background of "Healthy China 2030", and have important practical significance and social value.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
232
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jingjing Cao
- Phone Number: 86-13858061081
- Email: 13858061081@zju.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients in Ward 1 were assigned to the intervention group, and patients in Ward 2 served as the control group. The inclusion criteria were as follows: ① aged 18-60 years; ② diagnosed by cardiologists as meeting the clinical diagnostic criteria for myocardial infarction (MI) established by the Cardiology Branch of the Chinese Medical Association; ③ having basic smartphone operation skills to use the App normally; ④ providing informed consent and signing the research consent form.
Exclusion Criteria:
- ① Complicated with severe hepatic or renal insufficiency, malignant tumors, cognitive impairment, or mental illnesses; ② Patients with NYHA class Ⅳ or definite exercise contraindications (e.g., those assessed as high-risk in exercise risk evaluation) who are unable to participate in exercise prescription intervention; ③ Patients who have difficulty completing follow-up or withdraw midway.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group, On the basis of conventional rehabilitation guidance, the "Cardiac Rehabilitatio
|
Develop a targeted and actionable health management APP focusing on five major health issues (diet, medication, exercise, psychology, and smoking cessation).
The experimental group will use it for check-in, while the APP will be equipped with a management mechanism, and the intervention will last for 6 months.
|
|
Active Comparator: normal group, conventional rehabilitation guidance
|
① Before discharge, cardiologists will provide face-to-face health education to patients, covering the rehabilitation goals of myocardial infarction (MI), risk factor control, dietary recommendations, exercise precautions, medication adherence, and prevention of common complications.②
Patients will be given a uniformly compiled printed Cardiac Rehabilitation Guidance Manual for self-directed reading and learning.③
After discharge, the responsible nurse will conduct health follow-ups via phone call or WeChat at the 1st week, 1st month, 3rd month, and 6th month to monitor rehabilitation progress and medication compliance, and provide targeted guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Condition of Cardiac Function Recovery
Time Frame: Assessments will be conducted at four time points: before the intervention (T0), 1 month after the intervention (T1), 3 months after the intervention (T2), and 6 months after the intervention (T3).
|
It is evaluated by the 6-minute walk distance (6MWD, six minutes walk test).
|
Assessments will be conducted at four time points: before the intervention (T0), 1 month after the intervention (T1), 3 months after the intervention (T2), and 6 months after the intervention (T3).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life (QoL)
Time Frame: Assessments will be conducted at four time points: before the intervention (T0), 1 month after the intervention (T1), 3 months after the intervention (T2), and 6 months after the intervention (T3).
|
The Chinese version of the Seattle Angina Questionnaire (SAQ) [37] was used to assess patients' health-related quality of life over the past 4 weeks.
|
Assessments will be conducted at four time points: before the intervention (T0), 1 month after the intervention (T1), 3 months after the intervention (T2), and 6 months after the intervention (T3).
|
|
Patient Satisfaction
Time Frame: It will be distributed at three time points: 1 month after the intervention (T1), 3 months after the intervention (T2), and 6 months after the intervention (T3).
|
A self-designed questionnaire on App usage satisfaction will be used, covering 6 dimensions: interface friendliness, function practicality, personalization level, interactive experience, overall satisfaction, and recommendation willingness.
|
It will be distributed at three time points: 1 month after the intervention (T1), 3 months after the intervention (T2), and 6 months after the intervention (T3).
|
|
Self-Management Ability Score
Time Frame: Assessments will be conducted at four time points: before the intervention (T0), 1 month after the intervention (T1), 3 months after the intervention (T2), and 6 months after the intervention (T3).
|
The Chinese Self-Management Scale (CSMS) was used for assessment, which includes 3 dimensions (daily life management, disease medical management, and emotional cognitive management) with a total of 27 items.
|
Assessments will be conducted at four time points: before the intervention (T0), 1 month after the intervention (T1), 3 months after the intervention (T2), and 6 months after the intervention (T3).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
December 4, 2025
First Submitted That Met QC Criteria
December 4, 2025
First Posted (Actual)
December 17, 2025
Study Record Updates
Last Update Posted (Actual)
December 17, 2025
Last Update Submitted That Met QC Criteria
December 4, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY-2025-302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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