NCT07346664

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 11, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
Last Updated

January 16, 2026

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

January 8, 2026

Last Update Submit

January 8, 2026

Conditions

Transitional Care ModelCoronary Heart DiseaseMedication AdherenceSelf-efficacyLipid Profile

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence

    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 Outcomes (2)

  • Self-efficacy

    Baseline (before discharge) and 3 months after discharge

  • Lipid Profile

    Baseline (before discharge) and 3 months after discharge.

Study Arms (2)

routine nursing care group

OTHER

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: routine nursing care group

TCM intervention group

OTHER

Patients in the observation group received a 3-month TCM intervention delivered by specially trained nurses, in addition to routine nursing care.

Other: TCM intervention group

Interventions

routine nursing care groupOTHER

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.

routine nursing care group
TCM intervention groupOTHER

Patients in the observation group received a 3-month TCM intervention delivered by specially trained nurses, in addition to routine nursing care.

TCM intervention group

Eligibility Criteria

Age47 Years - 58 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with cognitive impairment
  • Patients with incomplete follow-up data.
  • Patients with comorbid malignancy
  • Patients with severe hepatic
  • Patients with renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Jiangsu People's Hospital Affiliated to Yangzhou University

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Conditions

Coronary DiseaseMedication Adherence

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Northern Jiangsu People's Hospital Affiliated to Yangzhou University

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 16, 2026

Study Start

July 11, 2022

Primary Completion

May 9, 2024

Study Completion

May 26, 2024

Last Updated

January 16, 2026

Record last verified: 2022-04

Locations

CN(1)