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

Sponsor

Cukurova University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06074887

Collaborator

TC Erciyes University (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Self Care	Behavioral: transtheoretical model-based intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: İntervention 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, the patient will be visited at home and final tests will be collected.
No Intervention: Control group

Arm

Intervention/Treatment

Experimental: İntervention 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, the patient will be visited at home and final tests will be collected.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

European Heart Failure Self-Care Behavior Scale [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 Outcome Measures

Minnesota Living with Heart Failure Questionnaire [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.
General Self-Efficacy Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Having a diagnosis of HF, being in classes 1, 2 and 3 according to NYHA functional classification and having an ejection fraction >35, 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.