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Clinical Trial Summary

Heart failure (HF) is a chronic and progressive disease in which typical symptoms and accompanying findings are observed as a result of low cardiac output and increased intracardiac pressures at rest or during exercise, caused by filling of the ventricles or excretion of blood. According to a study by the Turkish Society of Cardiology, the prevalence of the disease is 10% in people over 65 years of age and 2.9% in people over 35 years of age. At the same time, the prevalence of HF is significantly higher compared to similar population studies from Western countries, although the population in our country is younger on average than in these countries. The quality of life of HF patients is affected by lifelong treatment and symptoms of the disease. As a result, HF patients cannot continue their daily lives on their own and are unable to meet their own daily needs, so they rely on the care of others. For the treatment of HF and prevention of cardiovascular disease, the European Society of Cardiology guidelines (ESC) recommend training and rehabilitation at a high level of evidence (Class IIA). Cardiac rehabilitation (CR) programs aim to reduce cardiovascular risks, support healthy lifestyles, and improve quality of life. Transtheoretical Model (TTM), which is among the behavior change models, offers a promising approach to integrate the stages and processes of change into the CR process at home. When we look at the studies conducted with TTM, no studies have been found that implemented TTM-based interventions and CR interventions in HF patients. In this study, the effect of TTM-based cardiac rehabilitation training on self-care, quality of life and self-efficacy levels in heart failure patients will be examined. This research was planned as a pre-test, post-test, parallel group, randomized controlled study. The population of the research consists of HF patients who are being treated in the units of Adana City Hospital Cardiology Department. The sample size was calculated as 35 experiments and 35 controls, using the effect size of similar research in the literature. As data collection tools, socio-demographic characteristics information form, behavior change diagnosis form, Minnesota Life with Heart Failure Scale, European Heart Failure Self-Care Behavior Scale, General Self-Efficacy Scale, Home Visits Follow-up chart and Patient Follow-up Form, Telephone Counseling Follow-up chart and general situation evaluation form will be used. Participants who meet the inclusion criteria will be randomly assigned to groups and followed at home for 12 weeks. During the follow-up period, there will be 7 home visits and 5 telephone follow-ups for the experimental group participants, and 3 home visits for the control group participants. TTM-based CR home care program will be applied to the experimental group through home visits and telephone follow-up, no application will be made to the control group and the necessary data will be collected. SPSS 22.0 program will be used to perform descriptive and advanced analysis of the data. Scale use, ethics committee and institutional permission were obtained for this research.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT06074887
Study type Interventional
Source Cukurova University
Contact Hakan ÇELIK
Phone +905395042976
Email clkhakann@gmail.com
Status Not yet recruiting
Phase N/A
Start date October 2023
Completion date February 2024

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