- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07683143
A Nurse-Led Program to Improve Patient Health Promotion Behaviors Among Elderly Patients After PCI
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Henan
-
Kaifeng, Henan, China, 475000
- Huaihe Hospital of Henan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- a confirmed diagnosis of coronary heart disease with a stable condition following PCI
- age ≥60 years
- normal cognitive and communication abilities
- provision of written informed consent and voluntary participation in the study
Exclusion criteria:
- severe concomitant diseases affecting vital organs (e.g., liver, brain, or kidneys)
- current participation in other similar studies
Study Plan
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
|
|
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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
Sponsor
Publications and helpful links
General Publications
- Davis KM, Eckert MC, Hutchinson A, Harmon J, Sharplin G, Shakib S, Caughey GE. Effectiveness of nurse-led services for people with chronic disease in achieving an outcome of continuity of care at the primary-secondary healthcare interface: A quantitative systematic review. Int J Nurs Stud. 2021 Sep;121:103986. doi: 10.1016/j.ijnurstu.2021.103986. Epub 2021 May 27.
- Pender NJ. Health promotion in nursing practice[M]. Stamford: Appleton and Lange, 1996.
- Huang Z, Chair SY. Development and pilot testing of a nurse-led common-sense model of self-regulation-based heart failure self-care program. BMC Nurs. 2025 Jan 23;24(1):85. doi: 10.1186/s12912-025-02722-9.
- Karam M, Chouinard MC, Poitras ME, Couturier Y, Vedel I, Grgurevic N, Hudon C. Nursing Care Coordination for Patients with Complex Needs in Primary Healthcare: A Scoping Review. Int J Integr Care. 2021 Mar 19;21(1):16. doi: 10.5334/ijic.5518.
- Xiao L, Wang P, Fang Q, Zhao Q. Health-promoting Lifestyle in Patients after Percutaneous Coronary Intervention. Korean Circ J. 2018 Jun;48(6):507-515. doi: 10.4070/kcj.2017.0312.
- Wu J, Feng Y, Zhao Y, Guo Z, Liu R, Zeng X, Yang F, Liu B, Gu J, Tarimo CS, Shao W, Guo X, Li Q, Zhao L, Ma M, Shen Z, Zhao Q, Miao Y. Lifestyle behaviors and risk of cardiovascular disease and prognosis among individuals with cardiovascular disease: a systematic review and meta-analysis of 71 prospective cohort studies. Int J Behav Nutr Phys Act. 2024 Apr 22;21(1):42. doi: 10.1186/s12966-024-01586-7.
- Liu M, He X, Yang X, et al. Interpretation of Report on Cardiovascular Health and Diseases in China 2023. Chin J Cardiovasc Med. 2024;29(04):305-324.
- Fan G, Liu Q, Bi J et al. Association of ideal cardiovascular health behaviors with arterial stiffness and its progression: a cross-sectional and short-term follow-up study among physical examinees. Chin J Public Health. 2024;40(03):315-319.
- Wang L, Niu JY, Zhao ZY, Li M, Xu M, Lu JL, Wang TG, Chen YH, Wang SY, Dai M, Li L, Liu SS, Wang WQ, Xu Y, Bi YF. Ideal Cardiovascular Health is Inversely Associated with Subclinical Atherosclerosis: A Prospective Analysis. Biomed Environ Sci. 2019 Apr;32(4):260-271. doi: 10.3967/bes2019.036.
- Du R, Wang P, Ma L, Larcher LM, Wang T, Chen C. Health-related quality of life and associated factors in patients with myocardial infarction after returning to work: a cross-sectional study. Health Qual Life Outcomes. 2020 Jun 17;18(1):190. doi: 10.1186/s12955-020-01447-4.
- Yun JY, Yun YH. Health-promoting behavior to enhance perceived meaning and control of life in chronic disease patients with role limitations and depressive symptoms: a network approach. Sci Rep. 2023 Mar 24;13(1):4848. doi: 10.1038/s41598-023-31867-3.
- Alonso Salinas GL, Cepas-Guillen P, Leon AM, Jimenez-Mendez C, Lozano-Vicario L, Martinez-Avial M, Diez-Villanueva P. The Impact of Geriatric Conditions in Elderly Patients with Coronary Heart Disease: A State-of-the-Art Review. J Clin Med. 2024 Mar 25;13(7):1891. doi: 10.3390/jcm13071891.
- Tao S, Sun S, Wu S, Peng T, Cao L, Yan M, Ma J, Li H. Current status and influencing factors of health literacy among older adults in combined medical and nursing care institutions: a cross-sectional study. Front Public Health. 2024 Jan 16;11:1323335. doi: 10.3389/fpubh.2023.1323335. eCollection 2023.
- Sverre E, Peersen K, Weedon-Fekjaer H, Perk J, Gjertsen E, Husebye E, Gullestad L, Dammen T, Otterstad JE, Munkhaugen J. Preventable clinical and psychosocial factors predicted two out of three recurrent cardiovascular events in a coronary population. BMC Cardiovasc Disord. 2020 Feb 5;20(1):61. doi: 10.1186/s12872-020-01368-6.
- Wu C, Zheng Y, Zhang T, Liu M, Xian L, Xu Y. Incidence and Influencing Factors of In-Stent Restenosis After Percutaneous Coronary Intervention in Patients With Coronary Artery Disease: A Systematic Review and Meta-Analysis. Catheter Cardiovasc Interv. 2025 Sep;106(3):1682-1699. doi: 10.1002/ccd.31711. Epub 2025 Jul 1.
- Zhao T, Wu Z, Wang H, et al. Analysis of risk factors and nursing for recurrent acute myocardial infarction after PCI. Nurs Res Pract. 2025;22(01):69-75.
- Global Burden of Cardiovascular Diseases and Risks 2023 Collaborators. Global, Regional, and National Burden of Cardiovascular Diseases and Risk Factors in 204 Countries and Territories, 1990-2023. J Am Coll Cardiol. 2025 Dec 2;86(22):2167-2243. doi: 10.1016/j.jacc.2025.08.015. Epub 2025 Sep 24.
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
- HUSOM2025-518
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
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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