The Effect of Education Given to Patients With Heart Failure on Self-care, Drug Compliance and Quality of Life.
- Conditions
- Heart Failure
- Interventions
- Behavioral: Intervention transtheoretical model group
- Registration Number
- NCT05418478
- Lead Sponsor
- Harran University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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)
- Patients with communication difficulties
- Patients who cannot use tele-health applications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Intervention transtheoretical model 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
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Medication Compliance Notification Scale 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.
Minnesota Life with Heart Failure Survey 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.
New York Heart Association classification (NYHA) 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.
Trial Locations
- Locations (1)
Harran University
🇹🇷Şanlıurfa, Türki̇ye, Turkey