Uncertainty in HFrEF Patients

NCT05632198 | Completed

• 1 other identifier: AIBU-HSF-SDEMIR-02
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure with Reduced Ejection Fraction

Keywords

self care; quality of life; uncertainty

Outcome Measures

Primary Outcomes (3)

• Uncertainty (questionnaire)

  Mishel Uncertainty in Illness Scale-Community Form (MUIS-C) will be used to measure perceived uncertainty. The 20-item Turkish version of the scale has three sub-dimensions: Perception of the current situation (Cronbach's alpha = 0.86), perception of understanding (Cronbach's alpha = 0.78), ambiguity (Cronbach's alpha = 0.79). The total score is obtained by adding the scores given to each item of the five-point Likert scale. Thus, the score that can be obtained from the scale varies between 20 and 100, with an average of 60. An increase in the score obtained from the scale is interpreted as an increase in perceived uncertainty. Cronbach's alpha coefficients calculated in different HF populations using the scale ranged from 0.79 to 0.92, including the Turkish version.

  Baseline

• Quality of life (questionnaire)

  Left Ventricule Disfunction Scale (LVD-36) will be used to measure quality of life. The 36-item Turkish version of the scale consists of 36 items and the questions are presented to the patients with two options as true or false. The correct answers given are added together and the total number of correct answers found is expressed as a percentage. Scores between 0 and 100 are taken from the scale, and as the score increases, the quality of life decreases.Cronbach's alpha coefficient of the Turkish version of the scale was calculated as 0.87.

  Baseline

• Self-care behavior (questionnaire)

  European Heart Failure Self-Care Behavior Scale (EHFSeBS) will be used to measure self-care behavior. The scale is a 5-point Likert scale consisting of 12 questions that measures the definition of symptoms such as edema, respiratory distress, and fatigue related to HF, regular use of medications for these symptoms, fluid and salt restriction, communication with health personnel, and self-care assessment actions such as weight monitoring. The total score that can be obtained from the scale varies between 12-60. A high total score indicates low self-care, and a low score indicates high self-care. Cronbach's alpha coefficient of the Turkish version of the scale was calculated as 0.69.

  Baseline

Interventions

Survey OTHER

Valid and reliable questionnaires covering perceived uncertainty, self-care behaviors and quality of life will be administered.

Eligibility Criteria

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

Study Population

The study population identifies heart failure patients with reduced ejection fraction (\< %40) as evidenced by an echocardiogram.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Bolu, 14280, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Şeyma Demir Erbaş, PhD

  Bolu Abant Izzet Baysal University, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: November 30, 2022
• Study Start: June 15, 2023
• Primary Completion: June 11, 2024
• Study Completion: June 15, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-07

Locations

TU (1)