A Nurse-Led Program to Improve Patient Health Promotion Behaviors Among Elderly Patients After PCI
2 luglio 2026 aggiornato da: 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
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
78
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Henan
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Kaifeng, Henan, Cina, 475000
- Huaihe Hospital of Henan University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Nessun intervento: Gruppo di controllo
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Sperimentale: Gruppo di intervento
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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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Health Promotion Lifestyle Profile II
Lasso di tempo: From enrollment to 3 months post-intervention
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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.
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From enrollment to 3 months post-intervention
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Cardiac Self-Efficacy Scale
Lasso di tempo: From enrollment to 3 months post-intervention
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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.
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From enrollment to 3 months post-intervention
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Seattle Angina Questionnaire
Lasso di tempo: From enrollment to 3 months post-intervention
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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.
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From enrollment to 3 months post-intervention
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Blood Pressure
Lasso di tempo: From enrollment to 3 months post-intervention
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From enrollment to 3 months post-intervention
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Fasting Blood Glucose
Lasso di tempo: From enrollment to 3 months post-intervention
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From enrollment to 3 months post-intervention
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Six-Minute Walk Test
Lasso di tempo: From enrollment to 3 months post-intervention
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From enrollment to 3 months post-intervention
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Body Mass Index
Lasso di tempo: From enrollment to 3 months post-intervention
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From enrollment to 3 months post-intervention
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Left Ventricular Ejection Fraction
Lasso di tempo: From enrollment to 3 months post-intervention
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From enrollment to 3 months post-intervention
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
2 maggio 2025
Completamento primario (Effettivo)
20 novembre 2025
Completamento dello studio (Effettivo)
20 novembre 2025
Date di iscrizione allo studio
Primo inviato
24 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
2 luglio 2026
Primo Inserito (Effettivo)
6 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 luglio 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- HUSOM2025-518
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .