Myocardial InfarctionNCT07289815
Construction and Application of an Intelligent Collaborative Cardiac Rehabilitation App for Middle-aged and Young Patients With Myocardial Infarction
A study testing Cardiac Rehabilitation Management App and Conventional Rehabilitation Guidance in people with Myocardial Infarction and Cardiac Rehabilitation, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myocardial Infarction, Cardiac Rehabilitation, APP
- What is being tested?
- Cardiac Rehabilitation Management App and Conventional Rehabilitation Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Myocardial Infarction, Cardiac Rehabilitation, APP
- Being tested
- Cardiac Rehabilitation Management App, Conventional Rehabilitation Guidance
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation Management AppBehavioural
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.
Conventional Rehabilitation GuidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group, On the basis of conventional rehabilitation guidance, the "Cardiac Rehabilitatio | Experimental | Not described Receives: Behavioral: Cardiac Rehabilitation Management App |
| normal group, conventional rehabilitation guidance | Active comparator | Not described Receives: Behavioral: Conventional Rehabilitation Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condition of Cardiac Function Recovery
It is evaluated by the 6-minute walk distance (6MWD, six minutes walk test).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289815
- Sponsor's protocol ID
- KY-2025-302
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of an Intelligent Collaborative Cardiac Rehabilitation Management Model for Young and Middle-aged Patients With Myocardial Infarction Based on Intervention Mapping
- ClinicalTrials.gov ID
- NCT07289815
- Acronym / sponsor ID
- KY-2025-302
- Conditions
- Myocardial Infarction, Cardiac Rehabilitation, APP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group, On the basis of conventional rehabilitation guidance, the "Cardiac Rehabilitatio | Experimental | Behavioral: Cardiac Rehabilitation Management App |
| normal group, conventional rehabilitation guidance | Active comparator | Behavioral: Conventional Rehabilitation Guidance |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Rehabilitation Management AppDevelop 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. | Behavioural | experimental group, On the basis of conventional rehabilitation guidance, the "Cardiac Rehabilitatio |
| Conventional Rehabilitation Guidance① 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. | Behavioural | normal group, conventional rehabilitation guidance |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation Management App and Conventional Rehabilitation Guidance in people with Myocardial Infarction and Cardiac Rehabilitation, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingjing Cao (86-13858061081, 13858061081@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.