A Nurse-Led Program to Improve Patient Health Promotion Behaviors Among Elderly Patients After PCI
2. Juli 2026 aktualisiert von: 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
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
78
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Henan
-
Kaifeng, Henan, China, 475000
- Huaihe Hospital of Henan University
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Kontrollgruppe
|
|
|
Experimental: Interventionsgruppe
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Health Promotion Lifestyle Profile II
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cardiac Self-Efficacy Scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From enrollment to 3 months post-intervention
|
From enrollment to 3 months post-intervention
|
|
|
Fasting Blood Glucose
Zeitfenster: From enrollment to 3 months post-intervention
|
From enrollment to 3 months post-intervention
|
|
|
Six-Minute Walk Test
Zeitfenster: From enrollment to 3 months post-intervention
|
From enrollment to 3 months post-intervention
|
|
|
Body Mass Index
Zeitfenster: From enrollment to 3 months post-intervention
|
From enrollment to 3 months post-intervention
|
|
|
Left Ventricular Ejection Fraction
Zeitfenster: From enrollment to 3 months post-intervention
|
From enrollment to 3 months post-intervention
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
2. Mai 2025
Primärer Abschluss (Tatsächlich)
20. November 2025
Studienabschluss (Tatsächlich)
20. November 2025
Studienanmeldedaten
Zuerst eingereicht
24. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Juli 2026
Zuerst gepostet (Tatsächlich)
6. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. Juli 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- HUSOM2025-518
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .