CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled / 63 target
Drug / intervention
transtheoretical model-based interventionbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06074887
NCT06074887N/ACompletedHigh Momentum (2.2/mo)Completion was 19mo ago

The Effect of Transtheoretical Model-based Cardiac Rehabilitation Training on Self-care, Quality of Life, and Self-efficacy in Patients With Heart Failure

Cukurova University·interventional·Posted Oct 10, 2023·Updated Jun 23, 2026

In Brief

A clinical study evaluating transtheoretical model-based intervention for Heart Failure. Completed, enrolled 63 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

The main reason why heart failure (HF) is an important public health problem is that the incidence of HF is increasing and mortality rates remain unchanged despite the decline in the incidence of coronary artery disease. The ageing population and improved medical care services are the main factors supporting this increase. In the guidelines, education and rehabilitation are recommended for symptomatic HF patients with the highest level of evidence and recommendation (Class 1A) and considered as an integral part of HF treatment. The aim of this study was to investigate the effect of Transtheoretical Model-based cardiac rehabilitation training on self-care, quality of life and self-efficacy levels of HF patients. The study was conducted with a parallel-group, randomised controlled experimental design with pre-test and post-test measurements. Thirty-two experimental and 31 control patients, randomly assigned according to inclusion and exclusion criteria, were followed up at home for 12 weeks. Transtheoretical Model (TTM)-based CR training was applied to the intervention group through home visits. Data were collected through socio-demographic information form, behaviour change stage diagnostic form, Minnesota Living with Heart Failure Scale, European Heart Failure Self-Care Behaviour Scale, General Self-Efficacy Scale, home visit follow-up chart, patient follow-up form, telephone counselling follow-up chart and general condition assessment form. Number, percentage, mean and standard deviation were used for descriptive statistics; independent and dependent sample t-test, repeated measures ANOVA test, Chi-Square test, Fisher's Exact test, Fisher-Freeman-Halton Exact test, Wilcoxon Signed Ranks test, Mann-Whitney U test and Friedman test were used for comparative analyses. The findings showed that the TTM-based KR programme had a statistically significant effect on increasing the quality of life, self-efficacy and self-care levels and improving the clinical parameters of the patients in the intervention group. Improvement was observed in the NYHA classification of the patients in the intervention group and 96.9% of them were determined to have passed to the 'movement' stage of TTM. It is recommended that home-based CR programmes should be disseminated and health professionals should be trained in TTM-based interventions to improve the general condition and clinical parameters of HF patients. It is also recommended to investigate the effectiveness of TTM-based training programmes in different patient groups and to evaluate their long-term effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesTurkey (Türkiye)

Timeline

N/ACompletedFinished
202420252026
First PostedOct 10, 2023
Enrollment StartFeb 1, 2024
Primary CompletionNov 1, 2024
Study CompletionDec 15, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.7 years ago

Arms & Interventions

İntervention groupexperimental

Transtheoretical model-based cardiac rehabilitation group

Behavioral: transtheoretical model-based intervention
Control groupno_intervention

No intervention group

Interventions

transtheoretical model-based interventionbehavioral

Pretest data are collected for patients in the intervention group in a face-to-face interview in the hospital setting. The training prepared according to the behavior change phase will be conducted one week later in the patients' home environment and the required data will be collected. In the fourth week of the research, the patient is visited at home, the training prepared according to the behavior change phase is performed at the patient's home, and the required data will be collected. In the eighth week of the research, the patient is visited at home, the training prepared according to the behavior change phase is performed at the patient's home, and the required data will be collected. In the twelfth week of the study, post-tests will be collected in the hospital.