NCT07289815

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Jan 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

December 4, 2025

Last Update Submit

December 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Condition of Cardiac Function Recovery

    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 Outcomes (3)

  • Quality of Life (QoL)

    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

    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

    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).

Study Arms (2)

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

Interventions

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.

experimental group, On the basis of conventional rehabilitation guidance, the "Cardiac Rehabilitatio

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.

normal group, conventional rehabilitation guidance

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share