EligibleTrials

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

Recruiting · NCT06747689 · Observational (researchers observe without assigning treatment) · Lead sponsor: Dokuz Eylul University

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Heart Failure

What this trial is about

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.

Who can take part

Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)

Eligibility criteria (as published)

The study will include patients who: * Are diagnosed with heart failure according to international guidelines, * Are aged 18 years or older, * Can communicate via phone, and * Are willing to participate in the study. Exclusion Criteria: The study will exclude patients who: * Have been hospitalized within one month prior to inclusion, * Have experienced major psychological trauma or stress in the last three months, * Have serious comorbidities or malignant cancers, * Have advanced hearing impairment, * Are using prescription drugs for insomnia or psychiatric conditions, * Work night shifts, or * Reside in nursing homes.

Where it is running

1 location listed.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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