- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07346664
Medication Adherence and Lipid Management in Patients With Coronary Heart Disease After Percutaneous Coronary Intervention: Application of the Transitional Care Model
January 8, 2026 updated by: Qing Wang
Northern Jiangsu People's Hospital Affiliated to Yangzhou University
Patients with coronary heart disease (CHD) require long-term medication and lifestyle modification following percutaneous coronary intervention (PCI).
However, they often face challenges such as poor medication adherence and inadequate self-management.
This study aims to evaluate the effects of the transitional care model (TCM) on CHD patients after PCI, regarding medication adherence, self-efficacy, and lipid levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
TCM improved medication adherence, self-efficacy, and lipid profiles in CHD patients after PCI, while enhancing overall patient satisfaction.
Compared with routine nursing care, TCM yielded superior clinical benefits and is recommended for broader application in the post-PCI management of CHD patients.
Study Type
Interventional
Enrollment (Actual)
108
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 Locations
-
-
Jiangsu
-
Yangzhou, Jiangsu, China, 225001
- Northern Jiangsu People's Hospital Affiliated to Yangzhou University
-
-
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 clinically diagnosed with CHD according to established diagnostic criteria
- patients who met the World Health Organization (WHO) indications for PCI
- complete clinical data available
Exclusion Criteria:
- Patients with cognitive impairment
- Patients with incomplete follow-up data.
- Patients with comorbid malignancy
- Patients with severe hepatic
- Patients with renal insufficiency
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: routine nursing care group
Patients assigned to the control group underwent routine nursing care based on the standardized medical treatment, including admission health education (PCI postoperative risk management and medication instructions), psychological counseling, dietary and exercise guidance, individualized rehabilitation planning, and discharge instructions.
After discharge, patients attended routine outpatient follow-up visits, including laboratory testing of blood lipids, blood pressure, and blood glucose, without structured follow-up or WeChat-based education.
Routine outpatient education and guidance were provided only.
|
Patients assigned to the control group underwent routine nursing care based on the standardized medical treatment, including admission health education (PCI postoperative risk management and medication instructions), psychological counseling, dietary and exercise guidance, individualized rehabilitation planning, and discharge instructions.
After discharge, patients attended routine outpatient follow-up visits, including laboratory testing of blood lipids, blood pressure, and blood glucose, without structured follow-up or WeChat-based education.
Routine outpatient education and guidance were provided only.
|
|
Other: TCM intervention group
Patients in the observation group received a 3-month TCM intervention delivered by specially trained nurses, in addition to routine nursing care.
|
Patients in the observation group received a 3-month TCM intervention delivered by specially trained nurses, in addition to routine nursing care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Adherence
Time Frame: Baseline (before discharge) and 3 months after discharge
|
Medication adherence will be assessed using the Medication Adherence Report Scale-5 (MARS-5).
The scale consists of 5 items that evaluate nonadherent behaviors (e.g., forgetting to take medications, altering dosages).
Each item is scored on a 5-point Likert scale (1="always" to 5="never"), with total scores ranging from 5 to 25.
A higher total score indicates better medication adherence.
|
Baseline (before discharge) and 3 months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy
Time Frame: Baseline (before discharge) and 3 months after discharge
|
Self-efficacy will be assessed using the General Self-Efficacy Scale (GSS).
The GSS is a validated 16-item instrument, with each item scored from 0 to 4. Higher total scores reflect greater self-efficacy in managing health and adhering to treatment recommendations.
|
Baseline (before discharge) and 3 months after discharge
|
|
Lipid Profile
Time Frame: Baseline (before discharge) and 3 months after discharge.
|
Fasting serum levels of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be measured using an automated biochemical analyzer.
All measurements will be performed in mmol/L.
|
Baseline (before discharge) and 3 months after discharge.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
July 11, 2022
Primary Completion (Actual)
May 9, 2024
Study Completion (Actual)
May 26, 2024
Study Registration Dates
First Submitted
January 8, 2026
First Submitted That Met QC Criteria
January 8, 2026
First Posted (Estimated)
January 16, 2026
Study Record Updates
Last Update Posted (Estimated)
January 16, 2026
Last Update Submitted That Met QC Criteria
January 8, 2026
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No. 20240410
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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