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NCT Number: NCT07289815

Construction and Application of an Intelligent Collaborative Cardiac Rehabilitation App for Middle-aged and Young Patients With Myocardial Infarction

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac Rehabilitation Management App

Behavioral

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 Guidance

Behavioral

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.

Primary outcomes

  1. 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).

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jingjing Cao

CONTACT

[email protected]

86-13858061081

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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