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Active, Not Recruiting

NCT Number: NCT05418478

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Health Behavior Heart Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harran University

Sanliurfa, Türki̇ye, 63000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention transtheoretical model group

Behavioral

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).

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Jun 14, 2022
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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