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

NCT06747689 | Recruiting

• 1 other identifier: 2024/41-11
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Sleep Quality; Self Care; Cognitive Function

Outcome Measures

Primary Outcomes (2)

• Sleep quality

  The Pittsburgh Sleep Quality Index (PSQI) was developed by Buysse and colleagues in 1989. It is a scale that provides a quantitative measurement of sleep quality, distinguishing between good and poor sleep. Its validity and reliability study was conducted in Turkey in 1996 by Agargün and colleagues, with a Cronbach's alpha value of.80. The scale is a four-point Likert type and contains a total of 24 questions, comprising seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction. Each component is scored between 0 and 3 based on the frequency of symptoms. The sum of the seven component scores yields the total PSQI score, which ranges from 0 to 21. A total score of 5 or above indicates poor sleep quality and a high level of sleep disturbance.

  From December 2024 to January 2026

• Self Care

  Self-care will be assessed using the nine-item version of the European Heart Failure Self-Care Behavior Scale (Jaarsma et al., 2003). The validity and reliability of the scale in our country were established by Yıldız and Erci (Yıldız \& Erci, 2018). This Likert-type scale measures self-care behaviors such as recognizing symptoms like edema, dyspnea, and fatigue related to HF, adhering to regular medication use, monitoring weight, and restricting fluid and salt intake. Participants are asked to choose one of the following options for each item: completely agree (1), agree (2), undecided (3), disagree (4), or completely disagree (5). A higher total score indicates lower self-care, while a lower score indicates higher self-care. Fit measures for the Structural Equation Model of the scale include RMSEA = 0.047 (CI = 0.00-0.079), AGFI = 0.83, and GFI = 0.91 (Jaarsma et al., 2003). In the study by Yıldız and Erci, the Cronbach's alpha coefficient was reported as 0.82 (Yıldız \& Erci,2018)

  From December 2024 to January 2026

Secondary Outcomes (1)

• Cognitive Fuction

  From December 2024 to January 2026

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited from the cardiology clinic of Dokuz Eylül University Hospital.

You may not qualify if:

• The study will exclude patients who:
• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University Hospital

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Failure; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Arzu AKBABA

CONTACT

05373925654; arzu.akbaba@deu.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: December 20, 2024
• Primary Completion: June 20, 2025
• Study Completion: January 20, 2026
• Last Updated: February 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)