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

Harran University

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Behavioral: Intervention transtheoretical model group

Study type: Interventional

Funder types: Other

Identifiers

NCT05418478

46811200

Details and patient eligibility

About

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''.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Intervention transtheoretical model group

Control

No Intervention group

Description:

* 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).