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Clinical Trials/NCT05418478
NCT05418478
Active, Not Recruiting
N/A

The Effect of Training Given to Patients With Heart Failure Through Transtheoretic Model-based Telehealth Methods on Self-care, Drug Adherence and Quality of Life

Harran University1 site in 1 country80 target enrollmentJune 7, 2022
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Harran University
Enrollment
80
Locations
1
Primary Endpoint
European Heart Failure Self-Care Behaviors Scale
Status
Active, Not Recruiting
Last Updated
last year

Overview

Brief Summary

This study was planned as a randomized, controlled, experimental study to evaluate the effects of transtheoretic model-based education on self-care, drug compliance and quality of life in patients with heart failure. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses in follow-up and considering that non-parametric tests can be performed, the research group will consist of a total of 72 people, 36 in each group, with an increase of 20%. Patients with heart failure who do not have communication barriers to affect cognitive functions, can use tele-health applications (Smartphone and application), volunteers aged 18 and over and agree to participate in the study will be included in the intervention and control groups. The data of the study, "Socio-demographic Characteristic Data Form", "Question Form Regarding the Disease", "European Heart Failure Self-Care Behaviors Scale-12", "Beliefs About Medication Adherence Scale," in which socio-demographic characteristics and information about the disease were questioned. (IUHIO)'' and ''Minnesota Life with Heart Failure Questionnaire''.

Detailed Description

The patients in the intervention group will be trained through tele-health practices for at least 25-30 minutes on a transtheoretical basis, every 2 weeks in the 1st month and once a month in the following months. Tele-health applications include phone monitoring, SMS notification and application applications. Educational topics based on model-based self-care behaviors; It will include regular exercise, nutrition-weight monitoring, fluid intake-edema control, smoking cessation, regular drug use, regular rest, vaccination. Educational principles will be shared with patients by SMS from time to time during the education process. Treatment compliance levels and self-care behaviors of both groups of patients will be re-measured from the first week to the 6th month after the training, and any difference will be analyzed using statistical methods.

Registry
clinicaltrials.gov
Start Date
June 7, 2022
End Date
September 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

İbrahim Caner Di̇ki̇ci̇

Lecturer

Harran University

Eligibility Criteria

Inclusion Criteria

  • Have no communication barriers to affect cognitive functions,
  • Ejection-Fraction over 20
  • Diagnosed with Heart Failure for at least 6 months
  • Able to use tele-health applications (smartphone and application)

Exclusion Criteria

  • Patients with communication difficulties
  • Patients who cannot use tele-health applications

Outcomes

Primary Outcomes

European Heart Failure Self-Care Behaviors Scale

Time Frame: Baseline-6 months

The scale includes recognizing symptoms such as edema and weight gain, dyspnea, and fatigue associated with heart failure; It consists of 12 questions to measure self-care behaviors such as applying to a doctor and nurse for these symptoms, regular use of drugs, use of fluid and salt, treatment such as diet and exercise regimen and self-care behaviors such as weight monitoring and edema monitoring.

Secondary Outcomes

  • Medication Compliance Notification Scale(Baseline-6 months)
  • Minnesota Life with Heart Failure Survey(Baseline-6 months)
  • New York Heart Association classification (NYHA)(Baseline-6 months)

Study Sites (1)

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