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
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).
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abant Izzet Baysal University |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Completed |
NCT03614169 -
Direct HIS-pacing as an Alternative to BiV-pacing in Symptomatic HFrEF Patients With True LBBB
|
N/A | |
Recruiting |
NCT05278962 -
HF Patients With LVADs Being Treated With SGLT2i
|
Phase 4 | |
Completed |
NCT04210375 -
Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
|
Phase 1 | |
Not yet recruiting |
NCT06433687 -
Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients
|
||
Completed |
NCT05001165 -
Dashboard Activated Services and Tele-Health for Heart Failure
|
N/A | |
Active, not recruiting |
NCT03701880 -
Early Use of Ivabradine in Heart Failure
|
N/A | |
Recruiting |
NCT05650658 -
Left vs Left Randomized Clinical Trial
|
N/A | |
Not yet recruiting |
NCT06299436 -
Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
|
||
Recruiting |
NCT05992116 -
Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
|
||
Recruiting |
NCT05365568 -
Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: A Randomized Study
|
N/A | |
Active, not recruiting |
NCT05204238 -
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
|
||
Not yet recruiting |
NCT04420065 -
Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure
|
N/A | |
Terminated |
NCT03479424 -
Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
|
||
Completed |
NCT02113033 -
VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
|
Phase 2 | |
Recruiting |
NCT03209180 -
Immediate Release Versus Slow Release Carvedilol in Heart Failure
|
Phase 4 | |
Recruiting |
NCT05299879 -
Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study
|
||
Recruiting |
NCT05637853 -
Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
|
||
Completed |
NCT03870074 -
CPET Predicts Long-term Survival and Positive Response to CRT
|
||
Recruiting |
NCT04590001 -
Effect of the MobiusHD® in Patients With Heart Failure
|
N/A |