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

NCT ID: NCT06074887

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-12-15

Brief 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.

Conditions

Self Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

İntervention group

Transtheoretical model-based cardiac rehabilitation group

Group Type: EXPERIMENTAL

transtheoretical model-based intervention

Intervention Type: BEHAVIORAL

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.

Control group

No intervention group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

transtheoretical model-based intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Having a diagnosis of HF, being in classes 1, 2 and 3 according to NYHA functional classification and having an ejection fraction >30, being over 40 years of age, living within the borders of Adana province, having a telephone, and volunteering to participate in the study.

Exclusion Criteria

• Not being able to participate in practices regularly, having CR contraindications (Hypertrophic HF, aortic stenosis, angina pectoris, oncological diagnosis, advanced COPD, having received dialysis treatment, having had an MI for less than 6 months, pregnancy and obesity), and being actively enrolled in the CR program.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: collaborator

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Hakan ÇELİK

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

HOSPİTAL

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Related Links

https://www.proquest.com/docview/2571088679?pq-origsite=gscholar&fromopenview=true

Özdemir, V. A. (2009). Kronik kalp yetmezliği olan hastalarda yaşam kalitesinin değerlendirilmesi (Doctoral dissertation, Marmara Universitesi (Turkey)).

https://dergipark.org.tr/en/pub/inuefd/issue/8702/108659

Aypay, A. 2010. "Öz yeterlik ölçeğinin Türkçe'ye uyarlama çalışması", İnönü Üniversitesi Eğitim Fakültesi Dergisi, 11(2), 113-131.

Other Identifiers

TDK-2023-12974

Identifier Type: -

Identifier Source: org_study_id