The Effect of Education Given to Patients With Heart Failure on Self-care, Drug Compliance and Quality of Life.

March 17, 2025 updated by: İbrahim Caner Di̇ki̇ci̇, Harran University

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

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''.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Türki̇ye
      • Şanlıurfa, Türki̇ye, Turkey, 63000
        • Harran University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

Study group intervention: 7 sessions of transtheoretical model-based interview (2 in the first month, a total of 7 times, once a month), a structured disease education through transtheoretical model-based telehealth practices, and 6-month follow-up.

  • After the participants are included in the study, a health education structured according to the Transtheoretical model will be given to the patients in the study group through tele-health applications.
  • 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 first month and once a month in the following months. Tele-health applications include phone monitoring, SMS notification and application applications.
  • In the 6-month follow-up, there will be 2 follow-ups as pre-test (1st month) and post-test (6th month).
  • Behavioral: 7 sessions of behavior change training based on the transtoerytic model
Behavioral: Intervention transtheoretical model group

The Transtheoretical Model is a conscious behavior modification model that focuses on individual decision making and planning processes. It is the only model that examines behavior change as a dynamic process rather than an outcome, and considers behavioral strategies that include the individual's cognitive and behavioral processes in this process.

In the model, it is stated that behavior change is a process and develops gradually. It is reported that the change in the behavior of individuals consists of six stages: 1) not thinking, 2) thinking, 3) preparation, 4) taking action, 5) maintaining and 6) terminating. This model consists of four main constructs called change stages (time-related dimension), change processes/behavior modification methods (independent variable dimension), self-efficacy (levels of change) and decision-making balance (perceptions of harm and benefit of change).
No Intervention: Control
  • No notification will be made to the relatives of the patients in the control group. Control group patients will be called for routine control in line with their usual plans. After a total of 6 months from the beginning, the self-care and treatment compliance levels of the patients in the control group will be examined.
  • There will be 2 follow-ups as pre-test (1st month) and post-test (6th month).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Compliance Notification Scale
Time Frame: Baseline-6 months
The total test score is obtained by summing the scores obtained from the scale items evaluating drug compliance. Scores from the scale range from 5 to 25. An increase in the obtained scores indicates compatibility, and a decrease in scores indicates inconsistency.
Baseline-6 months
Minnesota Life with Heart Failure Survey
Time Frame: Baseline-6 months
The scale measures the effect of physical and social functionality on heart failure, as well as assessing the effect of common physical symptoms such as shortness of breath, fatigue, peripheral edema, anxiety and depression symptoms. The 21-item scale is in a six-point Likert type (never=0, very little=1, little=2, a little=3, a lot=4, a lot=5). The lowest score that can be obtained from the scale is 0, and the highest score is 105.
Baseline-6 months
New York Heart Association classification (NYHA)
Time Frame: Baseline-6 months
Classification of the clinical picture according to the functional status of the patients, from 1 to 4, patients are classified according to their physical activities.
Baseline-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harran University

Investigators

  • Study Director: İbrahim C Di̇ki̇ci̇, MSc, Harran Üniversitesi
  • Study Chair: Medet Korkmaz, PhD, Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Actual)

January 10, 2023

Study Completion (Estimated)

September 10, 2025

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

June 11, 2022

First Posted (Actual)

June 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46811200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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