A Nurse-Led Program to Improve Patient Health Promotion Behaviors Among Elderly Patients After PCI
2 de julio de 2026 actualizado por: 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
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
78
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Henan
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Kaifeng, Henan, Porcelana, 475000
- Huaihe Hospital of Henan University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Grupo de control
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Experimental: Grupo de intervención
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Health Promotion Lifestyle Profile II
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cardiac Self-Efficacy Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From enrollment to 3 months post-intervention
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From enrollment to 3 months post-intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de mayo de 2025
Finalización primaria (Actual)
20 de noviembre de 2025
Finalización del estudio (Actual)
20 de noviembre de 2025
Fechas de registro del estudio
Enviado por primera vez
24 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de julio de 2026
Publicado por primera vez (Actual)
6 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HUSOM2025-518
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .