The Effect of Uncertainty in Heart Failure

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

The Effect of Uncertainty on Self-care Behaviors and Quality of Life in Heart Failure Patients With Reduced Ejection Fraction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05632198
• Other study ID #: AIBU-HSF-SDEMIR-02
• Status: Not yet recruiting
• Start date: November 28, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2022
• Source: Abant Izzet Baysal University
• Contact: Muhammed Nur Ögün, Chief
• Phone: 0374 253 46 26
• Email: bolueah1[@]saglik.gov.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 122
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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