Ireland
--:--IST
Active, not recruiting Not applicable

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

NCT05418478 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2022-06-07
Last updated
2025-03-19

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Intervention transtheoretical model group

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).

Study 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''.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • European Heart Failure Self-Care Behaviors Scale — 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.

Trial sites (1)

FacilityCityRegionStatus
Harran University Sanliurfa Türki̇ye
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05418478 on ClinicalTrials.gov ↗ ← All trials in Turkey