Clinical Trial

Association Between Sleep Quality and Self-Care in Heart Failure Patients

Recruiting
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Record status
This record was last updated February 6, 2025 (before its estimated June 20, 2025 completion). Its status may not reflect the trial's current state.
Summary
The research will be conducted as a prospective and relational study to longitudinally investigate the effect of sleep quality on self-care in patients with heart failure (HF) and to evaluate the relationship between self-care, sleep quality, and cognitive functions. The sample size was calculated using the multiple linear regression model with the G\*Power Version 3.1 program. Based on a medium effect size of 0.15, an alpha of 0.05, a power of 0.95, and 18 predictors, the sample size was determined to be 188. Considering a potential dropout rate of 10%, it was decided to complete the study with a minimum of 207 participants. Data will be collected from patients who apply to the Dokuz Eylül University Cardiology Outpatient Clinic and meet the inclusion criteria. After signing the informed consent form, participants will be followed up at baseline, the 1st month, the 3rd month, and the 6th month by telephone. The Statistical Package for Social Sciences (SPSS) 24.0 will be used to analyze the numerical data of the research. Descriptive statistics, including number, percentage, mean, and standard deviation, as well as inferential statistics such as the χ2 test, t-test for independent groups, and multiple linear regression, will be employed in the data analysis.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-12-18; most recent amendment 2025-02-05.
Status change: Not Yet Recruiting → Recruiting 2025-02-05
Trial Details
NCT Number NCT06747689
Lead Sponsor Dokuz Eylul University
Conditions Heart Failure, Sleep Quality, Self Care, Cognitive Function
Enrollment 207 participants
Start Date 2024-12-20
Primary Completion 2025-06-20 (estimated)
Study Completion 2026-01-20 (estimated)
Updated on ClinicalTrials.gov 2025-02-06