Percutaneous Coronary InterventionNCT07683143
A Nurse-Led Program to Improve Patient Health Promotion Behaviors Among Elderly Patients After PCI
A study testing Nurse-led intervention in people with Percutaneous Coronary Intervention, run by Henan University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Nurse-led intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 2 May 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe concomitant diseases affecting vital organs (e.g., liver, brain, or kidneys)
- current participation in other similar studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- Nurse-led intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Nurse-led intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Promotion Lifestyle Profile II
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.
Measured: From enrollment to 3 months post-intervention
Secondary outcomes (7)
Cardiac Self-Efficacy Scale
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.
Measured: From enrollment to 3 months post-intervention
Seattle Angina Questionnaire
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.
Measured: From enrollment to 3 months post-intervention
Blood Pressure
Measured: From enrollment to 3 months post-intervention
Fasting Blood Glucose
Measured: From enrollment to 3 months post-intervention
Six-Minute Walk Test
Measured: From enrollment to 3 months post-intervention
Body Mass Index
Measured: From enrollment to 3 months post-intervention
Left Ventricular Ejection Fraction
Measured: From enrollment to 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start2 May 2025
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-fen Feng, Henan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683143
- Sponsor's protocol ID
- HUSOM2025-518
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39849430Davis 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.
PubMed 34242979Karam 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.
PubMed 33776605Xiao 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.
PubMed 29856145Wu 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.
PubMed 38650004Liu 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.
PubMed 31217062Du 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.
PubMed 32552846Yun 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.
PubMed 36964273Alonso 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.
PubMed 38610656Tao 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.
PubMed 38292383Sverre 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.
PubMed 32024471Wu 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.
PubMed 40598759
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction And Application Of An IMB Model-Based Health-Promoting Behavior Intervention Program For Elderly Patients With Coronary Heart Disease After PCI
- ClinicalTrials.gov ID
- NCT07683143
- Acronym / sponsor ID
- HUSOM2025-518
- Conditions
- Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Henan UniversityUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Nurse-led intervention |
| Control group | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- severe concomitant diseases affecting vital organs (e.g., liver, brain, or kidneys)
- current participation in other similar studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led interventionThe 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. | Behavioural | Intervention group |
Primary outcome
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.
7 secondary outcomes
Cardiac Self-Efficacy Scale
Time frame: From enrollment to 3 months post-intervention
Seattle Angina Questionnaire
Time frame: From enrollment to 3 months post-intervention
Blood Pressure
Time frame: From enrollment to 3 months post-intervention
Fasting Blood Glucose
Time frame: From enrollment to 3 months post-intervention
Six-Minute Walk Test
Time frame: From enrollment to 3 months post-intervention
Body Mass Index
Time frame: From enrollment to 3 months post-intervention
Left Ventricular Ejection Fraction
Time frame: From enrollment to 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- BackgroundPender NJ. Health promotion in nursing practice[M]. Stamford: Appleton and Lange, 1996.
- Results publication: PubMed 39849430Huang 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.
- Results publication: PubMed 34242979Davis 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.
- Results publication: PubMed 33776605Karam 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.
- Results publication: PubMed 29856145Xiao 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.
- Results publication: PubMed 38650004Wu 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.
- Results publicationLiu 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.
- Results publicationFan 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.
- Results publication: PubMed 31217062Wang 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.
- Results publication: PubMed 32552846Du 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.
- Results publication: PubMed 36964273Yun 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.
- Results publication: PubMed 38610656Alonso 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led intervention in people with Percutaneous Coronary Intervention, run by Henan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Promotion Lifestyle Profile II (time frame: From enrollment to 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07683143, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.