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

Self Care Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06074887
• Other study ID #: TDK-2023-12974
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: February 2024

Study information

• Verified date: October 2023
• Source: Cukurova University
• Contact: Hakan ÇELIK
• Phone: +905395042976
• Email: clkhakann[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Self Care

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cukurova University	TC Erciyes University

References & Publications (8)

Baydemir C, Ozdamar K, Unalir A. Validity of the Turkish version of the European Heart Failure Self-Care Behavior Scale. Anadolu Kardiyol Derg. 2013 Sep;13(6):573-9. doi: 10.5152/akd.2013.141. Epub 2013 May 10. — View Citation

Chouinard MC, Robichaud-Ekstrand S. Predictive value of the transtheoretical model to smoking cessation in hospitalized patients with cardiovascular disease. Eur J Cardiovasc Prev Rehabil. 2007 Feb;14(1):51-8. doi: 10.1097/HJR.0b013e328014027b. — View Citation

Degertekin M, Erol C, Ergene O, Tokgozoglu L, Aksoy M, Erol MK, Eren M, Sahin M, Eroglu E, Mutlu B, Kozan O. [Heart failure prevalence and predictors in Turkey: HAPPY study]. Turk Kardiyol Dern Ars. 2012 Jun;40(4):298-308. doi: 10.5543/tkda.2012.65031. Turkish. — View Citation

Gonzalez B, Lupon J, Herreros J, Urrutia A, Altimir S, Coll R, Prats M, Valle V. Patient's education by nurse: what we really do achieve? Eur J Cardiovasc Nurs. 2005 Jun;4(2):107-11. doi: 10.1016/j.ejcnurse.2005.03.006. — View Citation

Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1. Erratum In: J Am Coll Cardiol. 2023 Apr 18;81(15):1551. — View Citation

Li X, Yang S, Wang Y, Yang B, Zhang J. Effects of a transtheoretical model - based intervention and motivational interviewing on the management of depression in hospitalized patients with coronary heart disease: a randomized controlled trial. BMC Public Health. 2020 Mar 30;20(1):420. doi: 10.1186/s12889-020-08568-x. — View Citation

Paradis V, Cossette S, Frasure-Smith N, Heppell S, Guertin MC. The efficacy of a motivational nursing intervention based on the stages of change on self-care in heart failure patients. J Cardiovasc Nurs. 2010 Mar-Apr;25(2):130-41. doi: 10.1097/JCN.0b013e3181c52497. — View Citation

Zhu LX, Ho SC, Sit JW, He HG. The effects of a transtheoretical model-based exercise stage-matched intervention on exercise behavior in patients with coronary heart disease: a randomized controlled trial. Patient Educ Couns. 2014 Jun;95(3):384-92. doi: 10.1016/j.pec.2014.03.013. Epub 2014 Mar 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	European Heart Failure Self-Care Behavior Scale	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
Secondary	Minnesota Living with Heart Failure Questionnaire	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
Secondary	General Self-Efficacy Scale	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

External Links

•   Aypay, A. 2010. "Öz yeterlik ölçeginin Türkçe'ye uyarlama çalismasi", Inönü Üniversitesi Egitim Fakültesi Dergisi, 11(2), 113-131.
•   Özdemir, V. A. (2009). Kronik kalp yetmezligi olan hastalarda yasam kalitesinin degerlendirilmesi (Doctoral dissertation, Marmara Universitesi (Turkey)).