Congestive Heart FailureNCT04930484
Validity and Reliability of the Turkish Version of Performance Measure for Activities of Daily Living-8
An observational study of Congestive Heart Failure, run by Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Chronic heart failure (CHF) is characterized by limited exercise performance, which is mainly determined by disease-specific factors, such as diminished cardiac output, abnormal ventilatory response, and low perfusion in skeletal muscles, which lead to skeletal muscle dysfunction.1 Exercise intolerance and symptoms… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Congestive Heart Failure
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Feb 2021to 3 Aug 2021
- How long will I take part?
- 6 Months
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample size of the study was determined as at least 40 people, 5 times the number of items used in the scale.
Who may be able to join
- Patients aged between 45-75 years, who are conscious, able to answer all questions, can communicate in Turkish, diagnosed with CHF, have NYHA (New York Heart Association) heart failure functional classification II and III and agree to participate in the study will be included in the study.
Who cannot join
- CHF patients with NYHA functional class IV who were hospitalized, who are unable to cooperate, and not willing to participate.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Nurel
Akçaabat, Trabzon, 61100
Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
Trabzon
About this study
Official title: Cultural Adaptation, Validity and Reliability of the Turkish Version of Performance Measure for Activities of Daily Living-8
Chronic heart failure (CHF) is characterized by limited exercise performance, which is mainly determined by disease-specific factors, such as diminished cardiac output, abnormal ventilatory response, and low perfusion in skeletal muscles, which lead to skeletal muscle dysfunction.1 Exercise intolerance and symptoms may lead to activity restriction and further functional deterioration with the progression of CHF. There is some evidence that disease-specific self-report measures more quantify clinically relevant domains than measures of general health status and are generally more sensitive to clinical change. aim of the study is to investigate the validity and reliability of the PMADL-8 questionnaire in the Turkish population.
Read the detailed description
Chronic heart failure (CHF) is characterized by limited exercise performance, which is mainly determined by disease-specifi factors, such as diminished cardiac output, abnormal ventilatory response, and low perfusion in skeletal muscles, which lead to skeletal muscle dysfunction.Exercise intolerance and symptoms may lead to activity restriction and further functional deterioration with the progression of CHF.
There is some evidence that disease-specific self-report measures more quantify clinically relevant domains than measures of general health status and are generally more sensitive to clinical change. aim of the study is to investigate the validity and reliability of the PMADL-8 questionnaire in the Turkish population.
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive heart failure, Functional limitation, Questionnaire
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Measure For Activities Of Daily Living-8
The questionnaire consists of 8 questions. It is a daily living activities measurement questionnaire consisting of 4 categories (very easy = 1 point, easy = 2, difficult = 3 points, very difficult = 4 points). High scores indicate severe functional limitations.
Measured: 6 month
Chronic Heart Failure Questionnaire
The questionnaire consists of 20 questions and four sub-dimensions. The sub-dimensions of the scale are dyspnea (5 questions), fatigue (4 questions), mood (7 questions) and dominance (4 questions). The questions have Likert-type response options ranging from 1 (worst) to 7 (best). The higher the score, the higher the quality of life.
Measured: 6 month
Nothingham Health Profile
It is a general health questionnaire consisting of 6 sub-parameters consisting of energy level (ES), emotional reactions (ER), physical activity (FA), pain (A), sleep (U) and social isolation (SI) and a total of 38 items.
Measured: 6 month
Sociodemographic data form
Gender, age, height, weight, body mass index, complaints, concomitant diseases, smoking and alcohol history, New York Heart Association's (NYHA) Congestive Heart Failure Classification, Coronary Artery Disease Risk Factors (Kwong et al. Circulation 2003) will be questioned. . Shortness of breath (at rest and on exertion) will be assessed with the modified Borg Scale
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start3 Feb 2021
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- 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
- 68 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NUREL ERTURK, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930484
- Sponsor's protocol ID
- GO 20/1171
- Status last verified
- Feb 2022
- First submitted
- 11 Jun 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation, Validity and Reliability of the Turkish Version of Performance Measure for Activities of Daily Living-8
- ClinicalTrials.gov ID
- NCT04930484
- Acronym / sponsor ID
- GO 20/1171
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive heart failure, Functional limitation, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ahi Evren Chest and Cardiovascular Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 18 Jun 2021 (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.
Chronic heart failure (CHF) is characterized by limited exercise performance, which is mainly determined by disease-specific factors, such as diminished cardiac output, abnormal ventilatory response, and low perfusion in skeletal muscles, which lead to skeletal muscle dysfunction.1 Exercise intolerance and symptoms may lead to activity restriction and further functional deterioration with the progression of CHF. There is some evidence that disease-specific self-report measures more quantify clinically relevant domains than measures of general health status and are generally more sensitive to clinical change. aim of the study is to investigate the validity and reliability of the PMADL-8 questionnaire in the Turkish population.
Detailed description
Chronic heart failure (CHF) is characterized by limited exercise performance, which is mainly determined by disease-specifi factors, such as diminished cardiac output, abnormal ventilatory response, and low perfusion in skeletal muscles, which lead to skeletal muscle dysfunction.Exercise intolerance and symptoms may lead to activity restriction and further functional deterioration with the progression of CHF.
There is some evidence that disease-specific self-report measures more quantify clinically relevant domains than measures of general health status and are generally more sensitive to clinical change. aim of the study is to investigate the validity and reliability of the PMADL-8 questionnaire in the Turkish population.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size of the study was determined as at least 40 people, 5 times the number of items used in the scale.
Key inclusion criteria (1 listed)
- Patients aged between 45-75 years, who are conscious, able to answer all questions, can communicate in Turkish, diagnosed with CHF, have NYHA (New York Heart Association) heart failure functional classification II and III and agree to participate in the study will be included in the study.
Key exclusion criteria (1 listed)
- CHF patients with NYHA functional class IV who were hospitalized, who are unable to cooperate, and not willing to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance Measure For Activities Of Daily Living-8
Time frame: 6 month
The questionnaire consists of 8 questions. It is a daily living activities measurement questionnaire consisting of 4 categories (very easy = 1 point, easy = 2, difficult = 3 points, very difficult = 4 points). High scores indicate severe functional limitations.
Chronic Heart Failure Questionnaire
Time frame: 6 month
The questionnaire consists of 20 questions and four sub-dimensions. The sub-dimensions of the scale are dyspnea (5 questions), fatigue (4 questions), mood (7 questions) and dominance (4 questions). The questions have Likert-type response options ranging from 1 (worst) to 7 (best). The higher the score, the higher the quality of life.
Nothingham Health Profile
Time frame: 6 month
It is a general health questionnaire consisting of 6 sub-parameters consisting of energy level (ES), emotional reactions (ER), physical activity (FA), pain (A), sleep (U) and social isolation (SI) and a total of 38 items.
Sociodemographic data form
Time frame: 6 month
Gender, age, height, weight, body mass index, complaints, concomitant diseases, smoking and alcohol history, New York Heart Association's (NYHA) Congestive Heart Failure Classification, Coronary Artery Disease Risk Factors (Kwong et al. Circulation 2003) will be questioned. . Shortness of breath (at rest and on exertion) will be assessed with the modified Borg Scale
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 22 Feb 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital at 2 sites 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 1 inclusion and 1 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 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Performance Measure For Activities Of Daily Living-8 (time frame: 6 month). The study lists 4 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 22 Feb 2022.