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

NCT ID: NCT06747689

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-20

Study Completion Date

2026-01-20

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure Sleep Quality Self Care Cognitive Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Arzu AKBABA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dokuz Eylul University Hospital

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Arzu AKBABA

Role: CONTACT

05373925654

Facility Contacts

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Arzu AKBABA

Role: primary

+902324124797

Other Identifiers

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2024/41-11

Identifier Type: -

Identifier Source: org_study_id

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