- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07659951
Motivational Interviewing After Coronary Stenting
The Effect of Motivational Interviewing on Healthy Lifestyle Behaviors and Biochemical Parameters in Patients Undergoing Stent Implantation After Coronary Angiography
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Coronary artery disease is characterized by the development of atherosclerotic plaques in the epicardial coronary arteries, leading to progressive narrowing of the vessel lumen and reduced myocardial perfusion. Atherosclerosis is a chronic inflammatory process influenced by modifiable and non-modifiable risk factors. Modifiable risk factors include hypertension, diabetes mellitus, dyslipidemia, smoking, physical inactivity, and unhealthy dietary habits, while non-modifiable factors include age, sex, and genetic predisposition. Coronary artery disease is one of the leading causes of morbidity and mortality worldwide and is associated with major cardiovascular events such as myocardial infarction and stroke.
Lifestyle modification is a fundamental component of both primary and secondary prevention of coronary artery disease. However, a considerable proportion of patients continue unhealthy behaviors following coronary interventions, increasing the risk of recurrent cardiovascular events. For this reason, interventions aimed at promoting sustainable behavioral change are essential in this population. Health-promoting behaviors, including regular physical activity, balanced nutrition, stress management, medication adherence, and smoking cessation, are critical in reducing cardiovascular risk and improving clinical outcomes. Motivational interviewing is a patient-centered counseling approach designed to enhance intrinsic motivation for behavioral change. It is particularly effective in individuals who are ambivalent or resistant to change and is based on principles such as expressing empathy, developing discrepancy between current behaviors and health goals, rolling with resistance, and supporting self-efficacy. This approach is widely used in chronic disease management and nursing practice to support behavioral change.
In this study, a structured motivational interviewing-based intervention supported by educational sessions and reminder messages was developed to improve healthy lifestyle behaviors in patients with coronary artery disease who underwent coronary angiography and stent implantation and were followed in a cardiology outpatient clinic. The intervention was also designed to improve biochemical parameters, including lipid profile indicators and body mass index. This randomized controlled trial was conducted in the cardiology outpatient clinic of a tertiary training and research hospital in Istanbul, Türkiye. The study population consisted of adult patients with coronary artery disease who underwent stent implantation following coronary angiography and were under outpatient follow-up. The sample size was determined using a power analysis. Participants were allocated to the intervention and control groups using simple randomization. Inclusion criteria included age 18 years or older, ability to read and understand Turkish, at least one month post-stent implantation or balloon angioplasty, clinical stability, and access to a mobile phone. Patients with psychiatric disorders affecting participation, communication difficulties, or severe clinical instability were excluded.
The intervention group received a structured face-to-face educational session covering coronary artery disease, risk factors, nutrition, physical activity, stress management, sleep hygiene, and smoking cessation, followed by motivational interviewing sessions and twice-weekly reminder messages for three months. The control group received routine clinical follow-up without additional intervention. Health-promoting lifestyle behaviors were assessed using the Health-Promoting Lifestyle Profile II scale. Biochemical outcomes, including lipid profile parameters (HDL, LDL, total cholesterol, triglycerides) and body mass index, were used to evaluate clinical outcomes. Assessments were performed at baseline, at one month, and at three months. Body mass index was calculated as weight in kilograms divided by height in meters squared. Data were collected using standardized instruments and analyzed using appropriate statistical methods. Statistical significance was set at p < 0.05. Ethical approval was obtained from the relevant institutional ethics committee, and written informed consent was obtained from all participants before enrollment.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turquía (Türkiye), 34010
- Biruni University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged over 18 years,
- Able to understand Turkish and literate,
- Patients who had undergone stent placement after coronary angiography (at least 1 month after stent implantation or balloon angioplasty),
- Patients whose health status was appropriate for participation in the study,
- Patients who owned a mobile phone.
Exclusion Criteria:
- Patients with a diagnosed psychiatric disorder,
- Patients with whom communication could not be established,
- Patients with poor general health status.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Motivational Interviewing Program Group
Participants received a motivational interviewing program supported by education and twice-weekly reminder messages for three months in addition to routine outpatient follow-up.
|
A structured motivational interviewing program delivered by a trained researcher, supported by patient education and reminder messages aimed at improving healthy lifestyle behaviors and cardiovascular risk factor management.
|
|
Sin intervención: Routine Care Control Group
Participants received routine cardiology outpatient follow-up and standard care without motivational interviewing or reminder messages.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Health-Promoting Lifestyle Behaviors
Periodo de tiempo: Baseline, 1 month (intervention group), and 3 months after intervention.
|
Health-promoting lifestyle behaviors were assessed using the Health-Promoting Lifestyle Profile II (HPLP-II) scale.
The scale consisted of six sub-dimensions: spiritual growth, interpersonal relationships, nutrition, physical activity, health responsibility, and stress management.
|
Baseline, 1 month (intervention group), and 3 months after intervention.
|
|
Blood Lipid Profile
Periodo de tiempo: Baseline and 3 months after intervention.
|
Blood lipid parameters including HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides were measured using a biochemical monitoring form.
|
Baseline and 3 months after intervention.
|
|
Body Mass Index (BMI)
Periodo de tiempo: Baseline and 3 months after intervention.
|
Body mass index was calculated as weight in kilograms divided by height in meters squared (kg/m²).
|
Baseline and 3 months after intervention.
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.
- Uysal, H., & Enç, N. (2012). Motivational interview for compliance in patients with chronic heart failure. Turkish Journal of Cardiovascular Nursing, 3(3), 33-38. https://doi.org/10.5543/khd.2012.004
- Savucu, Y. (2020). Healthy life style behaviors. Journal of Sport and Recreation Researches, 2(1), 34-43.
- Özdemir, H., & Taşcı, S. (2013). Motivational interviewing technique and use of nursing. Journal of the Faculty of Health Sciences of Erciyes University, 1(1), 41-47.
- Ögel, K. (2009). Motivational interviewing. Türkiye Klinikleri Journal of Psychiatry-Special Topics, 2(2), 41-44.
- Koplay, M., & Erol, C. (2013). Coronary artery disease. Turkish Journal of Radiology Seminars, 1(1), 57-69. https://doi.org/10.5152/trs.2013.007
- Kızılırmak, M., & Demir, S. (2018). The motivational interview and using in nursing. Gümüşhane University Journal of Health Sciences, 7(4), 103-109.
- Gür, G., & Sunal, N. (2019). Determination of health perception and healthy lifestyle behaviors in patients with coronary artery disease. Journal of Health Sciences and Professions, 6(2), 210-219. https://doi.org/10.17681/hsp.420313
- Bilgin, S., & Evcimen, H. (2020). The use of motivational interview technique in overweight and obese adolescents. Journal of Duzce University Health Sciences Institute, 10(2), 258-262. https://dx.doi.org/10.33631/duzcesbed.553805
- Bahar, Z., Beşer, A., Gördes, N., Ersin, F., & Kıssal, A. (2008). Healthy Life Style Behavior Scale II: A reliability and validity study. Journal of Cumhuriyet University School of Nursing, 12(1), 1-13.
- Alpay, S. & Şahin, E. (2024). Use of motivational interviewing technique in obstetrics and gynecology nursing and midwifery postgraduate theses in Turkey. Journal of Women's Health Nursing, 10(2), 104-118.
- Akdemir, N., & Özer, Z. C. (2021). Coronary artery diseases and nursing care. In: Internal Medicine and Nursing Care. Akdemir N (ed.). Akademisyen Publishing, pp. 553-568.
- Açıkgöz, D., & Taşkın Yılmaz, F. (2025). The relationship of cardiovascular disease risk factors knowledge level and health perception with adherence to medication in coronary artery. University of Health Sciences Journal of Nursing, 7(2), 105112. https://doi.org/10.48071/sbuhemsirelik.1636048
- Savaşan, A., Ayten, M., & Ergene, O. (2013). Hopelessness and healthy life style behaviors in patients with coronary artery disorder. Journal of Psychiatric Nursing, 4(1). https://doi.org/10.5505/phd.2013.07279
- Rubak S, Sandbaek A, Lauritzen T, Christensen B. Motivational interviewing: a systematic review and meta-analysis. Br J Gen Pract. 2005 Apr;55(513):305-12.
- Methapatara W, Srisurapanont M. Pedometer walking plus motivational interviewing program for Thai schizophrenic patients with obesity or overweight: a 12-week, randomized, controlled trial. Psychiatry Clin Neurosci. 2011 Jun;65(4):374-80. doi: 10.1111/j.1440-1819.2011.02225.x.
- Kwiecinski J, Tzolos E, Williams MC, Dey D, Berman D, Slomka P, Newby DE, Dweck MR. Noninvasive Coronary Atherosclerotic Plaque Imaging. JACC Cardiovasc Imaging. 2023 Dec;16(12):1608-1622. doi: 10.1016/j.jcmg.2023.08.021.
- Jebari-Benslaiman S, Galicia-Garcia U, Larrea-Sebal A, Olaetxea JR, Alloza I, Vandenbroeck K, Benito-Vicente A, Martin C. Pathophysiology of Atherosclerosis. Int J Mol Sci. 2022 Mar 20;23(6):3346. doi: 10.3390/ijms23063346.
- Dobber J, Latour C, Snaterse M, van Meijel B, Ter Riet G, Scholte Op Reimer W, Peters R. Developing nurses' skills in motivational interviewing to promote a healthy lifestyle in patients with coronary artery disease. Eur J Cardiovasc Nurs. 2019 Jan;18(1):28-37. doi: 10.1177/1474515118784102. Epub 2018 Jun 15.
- Bjorkegren JLM, Lusis AJ. Atherosclerosis: Recent developments. Cell. 2022 May 12;185(10):1630-1645. doi: 10.1016/j.cell.2022.04.004. Epub 2022 May 2.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades cardíacas
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Isquemia miocardica
- Enfermedad de la arteria coronaria
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Disciplinas y actividades de comportamiento
- Asesoramiento directivo
- Asesoramiento
- Servicios de salud mental
- Entrevistas motivacionales
Otros números de identificación del estudio
- 2024-BİAEK/08-04
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .