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

NCT ID: NCT05418478

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-07
• Study Completion Date: 2025-09-10

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Intervention transtheoretical model group

Intervention Type: 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).

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harran University

OTHER

Sponsor Role: lead

Responsible Party

İbrahim Caner Di̇ki̇ci̇

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İbrahim C Di̇ki̇ci̇, MSc

Role: STUDY_DIRECTOR

Harran Üniversitesi

Medet Korkmaz, PhD

Role: STUDY_CHAIR

Inonu University

Locations

Harran University

Sanliurfa, Türki̇ye, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Other Identifiers

46811200

Identifier Type: -

Identifier Source: org_study_id