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Completed

NCT Number: NCT06074887

The Effect of Model-based Cardiac Rehabilitation 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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HOSPİTAL

Adana, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transtheoretical model-based intervention

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Collaborators

  • TC Erciyes University
  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

The Effect of a Nurse-led, Transtheoretical Model-based Home Education and Follow-up Programme on Self-care Behaviour in Patients With Heart Failure: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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