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

Last updated: February 5, 2025
Sponsor: Dokuz Eylul University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

N/A

Clinical Study ID

NCT06747689
2024/41-11
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 207
Study Start date:
December 20, 2024
Estimated Completion Date:
January 20, 2026

Connect with a study center

  • Dokuz Eylul University Hospital

    Izmir,
    Turkey

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.