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

June 19, 2026 updated by: Hakan ÇELİK, Cukurova University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria Having a diagnosis of heart failure NYHA class I-III Ejection fraction >30% Age 40-75 years Living within the borders of Adana province Having a telephone Volunteering to participate in the study At least primary school graduate

Exclusion Criteria:

Unable to participate regularly in the intervention/follow-up Currently enrolled in an active cardiac rehabilitation program Contraindications for cardiac rehabilitation Hypertrophic heart failure Advanced aortic stenosis Angina pectoris Oncological diagnosis Advanced COPD Dialysis treatment Myocardial infarction within the last 6 months Pregnancy Morbid obesity Cognitive dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention group
Experimental: İntervention group
Transtheoretical model-based cardiac rehabilitation group
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Heart Failure Self-Care Behavior Scale
Time Frame: 12 weeks
Turkish validity and reliability study of this measurement tool, which measures the self-care behaviors of HF patients, by Baydemir et al. (2013). This scale consists of 12 items, 4 sub-dimensions and a 5-point Likert structure. A low score obtained from the scale indicates high self-care behavior
12 weeks
Minnesota Living with Heart Failure Questionnaire
Time Frame: 12 weeks
The Turkish validity and reliability study of this scale, which measures the quality of life of HF patients, was conducted by Özdemir (2009). This scale consists of 21 items, 2 sub-dimensions and a 6-point structure. A low score obtained from the scale indicates a high quality of life.
12 weeks
General Self-Efficacy Scale
Time Frame: 12 weeks
The Turkish validity and reliability study of this measurement tool, which measures the self-efficacy level of individuals, was conducted by Aypay (2010). This scale consists of 10 items, 1 sub-dimension and a 4-point Likert structure. A low score obtained from the scale indicates that the general self-efficacy level is low.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test
Time Frame: 12 week
The 6-minute walk test is used as a simple measure of aerobic exercise capacity for patients with heart failure. During this test, the patient walks on a 30-meter-long track with a solid surface at a normal pace for six minutes. The patient's vital signs are checked before and during the test. Conditions such as chest pain and severe shortness of breath require the test to be terminated. Patients with mild heart failure usually walk 300-450 metres and advanced patients walk 150-300 metres
12 week
Body Composition
Time Frame: 12 week
It is a device that analyzes parameters such as body fluid distribution, and muscle and fat mass. The Tanita RD 545 Smart Digital Scale is manufactured by Tanita Corporation, Tokyo, Japan. Thanks to mobile application compatibility, data can be stored and analyzed digitally. It was used in the study to evaluate body mass index, intracellular fluid, and extracellular fluid distribution.
12 week
Ejection fraction
Time Frame: 12 week
Ejection fraction was assessed by a physician in the hospital setting using echocardiographic evaluation. The measurement was recorded as a percentage and used to evaluate changes in left ventricular systolic function from baseline to the end of the 12-week follow-up period.
12 week
HbA1c
Time Frame: 12 week
HbA1c level was assessed in the hospital setting using a blood test requested/evaluated by a physician. The measurement was recorded as a percentage and used to evaluate changes in glycemic control from baseline to the end of the 12-week follow-up period.
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Collaborators

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

December 15, 2024

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDK-2023-12974

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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