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

Primary Purpose

Self Care

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transtheoretical model-based intervention
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Self Care focused on measuring Transtheoretical Model, Cardiac Rehabilitation, Heart Failure, Self Care, Quality of Life, Self Efficacy

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    İntervention group

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    October 4, 2023
    Last Updated
    October 4, 2023
    Sponsor
    Cukurova University
    Collaborators
    TC Erciyes University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06074887
    Brief Title
    The Effect of Model-based Cardiac Rehabilitation on Self-care, Quality of Life, and Self-efficacy in Patients With Heart Failure
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cukurova University
    Collaborators
    TC Erciyes University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Self Care
    Keywords
    Transtheoretical Model, Cardiac Rehabilitation, Heart Failure, Self Care, Quality of Life, Self Efficacy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    İntervention group
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    transtheoretical model-based intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    European Heart Failure Self-Care Behavior Scale
    Description
    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
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Minnesota Living with Heart Failure Questionnaire
    Description
    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.
    Time Frame
    12 weeks
    Title
    General Self-Efficacy Scale
    Description
    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.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 >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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hakan ÇELİK
    Phone
    +905395042976
    Email
    clkhakann@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Betül ÖZEN
    Phone
    +905319239295
    Email
    betulkocaturk@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    35379503
    Citation
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    PubMed Identifier
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    Citation
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    Description
    Aypay, A. 2010. "Öz yeterlik ölçeğinin Türkçe'ye uyarlama çalışması", İnönü Üniversitesi Eğitim Fakültesi Dergisi, 11(2), 113-131.

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