Clinical trial NCT05632198: Uncertainty in HFrEF Patients
Official title: UNCERTAINTY AS a BARRIER to SELF-CARE and QUALITY of LIFE in PATIENTS with HEART FAILURE with REDUCED EJECTION FRACTION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure with Reduced Ejection Fraction
Keywords: self care
quality of life
uncertainty
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population identifies heart failure patients with reduced ejection fraction (\< %40) as evidenced by an echocardiogram.

Brief summary: This study was planned as a descriptive and correlational type study to reveal the effect of perceived uncertainty by heart failure (HF) patients with reduced ejection fraction on quality of life and self-care behaviors. In this study, which aimed to reach 122 inpatients with HF, the dependent variables were quality of life and self-care behaviors, the independent variable will be perceived uncertainty. Data will be collected by Mishel Uncertainty in Illness Scale-Community Form (MUIS-C), Left Ventricular Disfunction Scale (LVD-36) and European Heart Failure Self-Care Behavior Scale (EHFSeBS). Data analysis will basically be done with Multivariate Analysis of Variance (MANOVA).

Detailed description: This study aims to reveal the effect of perceived uncertainty on quality of life and self-care behaviors in HF patients with reduced ejection fraction. This descriptive and correlational study will include 122 HF patients hospitalized in the cardiology department of a university hospital in northern Turkey. The sample size was calculated according to parameters based on the power of 90%, 95% confidence interval, error level of 0.05, effect size of 0.59. Data will be collected by Mishel Uncertainty in Illness Scale-Community Form (MUIS-C), Left Ventricular Disfunction Scale (LVD-36) and European Heart Failure Self-Care Behavior Scale (EHFSeBS). Data analysis will basically be done with Multivariate Analysis of Variance (MANOVA).

Eligibility criteria: Inclusion Criteria:

* 18 years or older,
* Having been diagnosed with heart failure by a physician for more than 6 months,
* Left ventricular ejection fraction \<40% as measured by echocardiography,
* Volunteering in participating in the study

Exclusion Criteria:

* Being under antidepressant treatment,
* Presence of a pre-existing psychiatric illness or cognitive impairment,
* Diagnosed with cancer and being under treatment related to cancer,
* Presence of chronic obstructive pulmonary disease.

Primary outcomes:
measure: Uncertainty (questionnaire)
timeFrame: Baseline
measure: Quality of life (questionnaire)
timeFrame: Baseline
measure: Self-care behavior (questionnaire)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University
Study officials:
affiliation: Bolu Abant Izzet Baysal University, Faculty of Health Sciences
name: Şeyma Demir Erbaş, PhD
role: PRINCIPAL_INVESTIGATOR
References: