Association Between Sleep Quality and Self-Care in Heart Failure Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure, Sleep Quality, Self Care, Cognitive Function. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Sleep Quality on Self-Care in Patients with Heart Failure: a Longitudinal Analysis
Overview
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.
Primary outcome measures
- Sleep quality [Time frame: From December 2024 to January 2026]
- Self Care [Time frame: From December 2024 to January 2026]
Secondary outcome measures (1)
- Cognitive Fuction [Time frame: From December 2024 to January 2026]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Dokuz Eylul University Hospital — Izmir
Identifiers
NCT: NCT06747689 · 2024/41-11