Heart Failure with Reduced Ejection FractionNCT05632198
Uncertainty in HFrEF Patients
An observational study of Heart Failure with Reduced Ejection Fraction, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure with Reduced Ejection Fraction
- What is being tested?
- Survey
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 15 Jun 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population identifies heart failure patients with reduced ejection fraction (< %40) as evidenced by an echocardiogram.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University
Bolu, Bolu, 14280
About this study
Official title: UNCERTAINTY AS a BARRIER to SELF-CARE and QUALITY of LIFE in PATIENTS with HEART FAILURE 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).
Read the 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).
- Being tested
- Survey
- Keywords
- self care, quality of life, uncertainty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Valid and reliable questionnaires covering perceived uncertainty, self-care behaviors and quality of life will be administered.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start15 Jun 2023
- Primary completion11 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure with Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 118 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Demir, Abant Izzet Baysal University
- Investigators
- Şeyma Demir Erbaş, PhD, Principal investigator, Bolu Abant Izzet Baysal University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632198
- Sponsor's protocol ID
- AIBU-HSF-SDEMIR-02
- Status last verified
- Jul 2024
- First submitted
- 21 Nov 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNCERTAINTY AS a BARRIER to SELF-CARE and QUALITY of LIFE in PATIENTS with HEART FAILURE with REDUCED EJECTION FRACTION
- ClinicalTrials.gov ID
- NCT05632198
- Acronym / sponsor ID
- AIBU-HSF-SDEMIR-02
- Keywords
- self care, quality of life, uncertainty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population identifies heart failure patients with reduced ejection fraction (< %40) as evidenced by an echocardiogram.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyValid and reliable questionnaires covering perceived uncertainty, self-care behaviors and quality of life will be administered. | Other | – |
Primary outcome
Uncertainty (questionnaire)
Time frame: Baseline
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.
Quality of life (questionnaire)
Time frame: Baseline
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.
Self-care behavior (questionnaire)
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şeyma Demir Erbaş, PhD principal investigator
Bolu Abant Izzet Baysal University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure with Reduced Ejection Fraction, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncertainty (questionnaire) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.