A Nurse-Led Program to Improve Patient Health Promotion Behaviors Among Elderly Patients After PCI

July 2, 2026 updated by: Zhi-fen Feng, Henan University

Construction And Application Of An IMB Model-Based Health-Promoting Behavior Intervention Program For Elderly Patients With Coronary Heart Disease After PCI

The goal of this study is to develop and evaluate a nurse-led intervention program based on the Information-Motivation-Behavioral Skills (IMB) model to improve health-promoting behaviors and quality of life in elderly patients after percutaneous coronary intervention (PCI). It will also learn about the program's effects on self-efficacy and relevant objective clinical indicators. The main questions it aims to answer are:

Does the IMB-based nurse-led intervention improve health-promoting behaviors in elderly PCI patients? What effects does the intervention have on patients' self-efficacy, quality of life, and objective clinical indicators? Researchers will compare the nurse-led IMB-based intervention to usual care to see if the program effectively enhances health-promoting behaviors and quality of life.

Participants will:

Receive the IMB-based nurse-led intervention or usual care Be followed up for a specified period with regular assessments Complete questionnaires on health-promoting behaviors, self-efficacy, and quality of life at baseline and at designated time points post-intervention Have objective clinical indicators measured and recorded

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

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

    • Henan
      • Kaifeng, Henan, China, 475000
        • Huaihe Hospital of Henan 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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. a confirmed diagnosis of coronary heart disease with a stable condition following PCI
  2. age ≥60 years
  3. normal cognitive and communication abilities
  4. provision of written informed consent and voluntary participation in the study

Exclusion criteria:

  1. severe concomitant diseases affecting vital organs (e.g., liver, brain, or kidneys)
  2. current participation in other similar studies

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group

The intervention group received a nurse-led IMB-based program plus standard care, delivered by an eight-member team from surgery to 4 weeks post-discharge.

Information: In-hospital sessions (10-15 min) with teach-back, group peer support, a discharge handbook, and weekly phone/video follow-ups.

Motivation: Three in-hospital motivational interviewing sessions (15-20 min) plus weekly post-discharge calls to enhance intrinsic motivation and family involvement.

Behavioral Skills: Hands-on training via demos, simulations, and role-playing (15-20 min) with real-time feedback, discharge review, and post-discharge dynamic adjustments.

Core Content: Six domains-health responsibility, nutrition, physical activity, stress management, interpersonal relations, and spiritual growth-each integrating IMB components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Promotion Lifestyle Profile II
Time Frame: From enrollment to 3 months post-intervention
The Health Promotion Lifestyle Profile II cocomprises six dimensions with a total of 52 items. Each item is rated on a 4-point Likert scale, yielding a total score ranging from 52 to 208, with higher scores indicating better health-promoting behaviors. Total scores of 52-91 indicate a poor level of health-promoting lifestyle, 92-131 indicate a moderate level, 132-171 indicate a good level, and 172-208 indicate an excellent level.
From enrollment to 3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Self-Efficacy Scale
Time Frame: From enrollment to 3 months post-intervention
The cardiac self-efficacy scale consists of two dimensions and includes a total of 16 items. Each item is rated using a 5-point Likert scale, with total scores ranging from 0 to 64. Higher scores indicate greater self-efficacy in managing disease-related problems.
From enrollment to 3 months post-intervention
Seattle Angina Questionnaire
Time Frame: From enrollment to 3 months post-intervention
The Seattle Angina Questionnaire (SAQ) is a 19-item instrument comprising five domains that assess disease-specific functional status and quality of life in patients with coronary heart disease. Each domain score is standardized to a range of 0 to 100, with higher scores indicating better health status and quality of life.
From enrollment to 3 months post-intervention
Blood Pressure
Time Frame: From enrollment to 3 months post-intervention
From enrollment to 3 months post-intervention
Fasting Blood Glucose
Time Frame: From enrollment to 3 months post-intervention
From enrollment to 3 months post-intervention
Six-Minute Walk Test
Time Frame: From enrollment to 3 months post-intervention
From enrollment to 3 months post-intervention
Body Mass Index
Time Frame: From enrollment to 3 months post-intervention
From enrollment to 3 months post-intervention
Left Ventricular Ejection Fraction
Time Frame: From enrollment to 3 months post-intervention
From enrollment to 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 2, 2025

Primary Completion (Actual)

November 20, 2025

Study Completion (Actual)

November 20, 2025

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • HUSOM2025-518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD from this study will not be shared due to ethical, legal, and practical reasons. Patient privacy is paramount; even de-identified data pose re-identification risks. Informed consent does not cover external data sharing. The behavioral intervention data are context-specific and may be misinterpreted outside this setting. Institutional policies and intellectual property rights restrict access to intervention materials. Secondary analyses without oversight risk erroneous conclusions. Resource constraints also limit data preparation. For these reasons, IPD will not be shared.

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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