Clinical Trial

The Effect of Education on Symptom Burden, Medication Adherence, and Nutritional Behaviour

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Record status
This record was last updated June 13, 2025 (before its estimated September 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study aims to determine the effect of online education structured according to Pender's Health Promotion Model on symptom burden, medication adherence, and nutritional behaviour in patients with heart failure. The sample size was calculated using the 'G. Power-3.1.9.2' programme at a 95% confidence level prior to data collection. Accordingly, the minimum sample size required for the independent sample t-test for the study was determined to be 44 (22 for each group) based on an alpha value of 0.05, an effect size of 1.128, and a theoretical power of 95%. Taking data losses into account, a total of 60 patients (30 for each group) were planned to be included in the sample. Data will be collected using the Heart Failure Symptom Status Scale, Medication Adherence and Prescription Printing Scale (İURYÖ-7), Heart Failure Nutrition Behaviour Scale. 1: Prior to providing education to patients, they will be informed about the purpose of the study, the data collection method, and the topics to be covered in the education. Patients who agree to participate in the study will be asked to sign an informed consent form. All patients in the experimental and control groups will be asked to complete the Heart Failure Nutrition Behaviour Scale (HFNBS), Heart Failure Symptom Status Scale (HFSSS), and Medication Adherence and Prescription Writing Scale (MAPWS-79) before receiving education. 2: The contact information of all patients in the experimental group will be collected. Training will be provided online at a time and date convenient for the patients. 3: Patients in the control group will receive a digital training booklet prepared by the researcher at the contact address they provide. 4: Participants will be contacted 2 weeks, 1 month, and 2 months after the initial education session to obtain feedback on post-education dietary behaviours, medication adherence, and symptoms. 5: Four to six weeks after the training is completed, the 'Nutritional Behaviour Scale in Heart Failure,' 'Heart Failure Symptom Status Scale,' and 'Medication Adherence and Prescription Writing Scale (İURYÖ-7)' will be completed online again. The same forms will also be completed online by patients in the control group 4-6 weeks later.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-04.
Trial Details
NCT Number NCT07017751
Lead Sponsor Naile ALANKAYA
Conditions Heart Diseases, Heart Failure
Enrollment 60 participants
Start Date 2025-07-15
Primary Completion 2025-09-15 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-13