- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07753915
A Study on the Development and Application of a Cardiac Rehabilitation Nursing Intervention Protocol for Patients With First-Episode Acute Myocardial Infarction Following PCI, Based on a Socio-Ecological Theory Model
The purpose of this [Study Type: Clinical Trial] is to investigate whether a cardiac rehabilitation nursing intervention based on the socio-ecological model can improve rehabilitation-related outcomes in patients. The study population consists of [adult patients with acute myocardial infarction who have undergone percutaneous coronary intervention (PCI)]. The primary research questions addressed in this study are:
- Can a social-ecological model-based cardiac rehabilitation intervention improve adherence to cardiac rehabilitation among patients with myocardial infarction following PCI?]
- Can a social-ecological model-based cardiac rehabilitation intervention improve cardiac function and quality of life among patients with myocardial infarction following PCI?] The researchers will compare the [intervention group and the control group] to observe whether there are [group differences in cardiac rehabilitation adherence, cardiac function, and quality of life levels].
Intervention group: Receives routine cardiology care combined with a social-ecological model-based cardiac rehabilitation intervention (1. In-hospital guidance; 2. Multidimensional, continuous rehabilitation support at home and in the community; 3. Regular follow-up assessments, etc.); Control Group: Received routine care from the cardiology department and standard discharge cardiac rehabilitation education; All participants completed questionnaire surveys and had cardiac function-related indicators collected at baseline, 3 months into the intervention, and 6 months into the intervention.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Liaoning
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Jinzhou, Liaoning, China, 121001
- The First Affiliated Hospital of Jinzhou Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with a first-time diagnosis of acute myocardial infarction who underwent PCI for the first time;
- Age ≥ 18 years;
- Alert and able to communicate effectively; ④ Willing to participate and sign an informed consent form.
Exclusion Criteria:
- Presence of absolute contraindications to exercise (e.g., unstable angina, severe heart failure, malignant arrhythmias, etc.);
- Concurrent severe comorbidities (e.g., end-stage renal disease, malignant tumors, severe cognitive impairment);
- Participation in other rehabilitation clinical trials.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
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Building on routine cardiac nursing care, implement a cardiac rehabilitation nursing intervention based on the socio-ecological model, with an intervention period of 1 month.
Interventions were carried out at the individual, interpersonal, organizational, community, and policy levels: at the individual level, guidance was provided on exercise, diet, medication, and emotional management; at the organizational level, a multidisciplinary rehabilitation team was established; at the interpersonal level, family members were mobilized to participate in collaborative care; at the community level, a system of continuous follow-up management was established, with monthly online and in-person rehabilitation guidance and assessments; and at the policy level, policy interpretation and guidance were provided to different population groups.
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No Intervention: Control Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Left Ventricular Ejection Fraction
Time Frame: From enrollment through the end of the three-month follow-up
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From enrollment through the end of the three-month follow-up
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- JZMULL2025435
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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