Arthritis, RheumatoidNCT05244824
Adaptation of EDAQ Into Turkish, Examining The Reliability and Validity For People With RA
An observational study of Arthritis, Rheumatoid and Activities of Daily Living, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to adapt the Evaluation of Daily Activity Questionnaire into Turkish language, and to examine the reliability and validity for people with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid, Activities of Daily Living
- What is being tested?
- Adaptation into Turkish, Examining The Reliability and Validity for People with RA
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2021to 30 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Since the Rasch analysis was used to evaluate the construct validity, it was determined that regardless of whether the scale was targeted well or not and considering the 99% confidence probability that item estimation was sufficient, a sample size of at least 210 should be taken, and 80 people should be taken for test-retest reliability.
Who may be able to join
- Being 18 years of age and older
- A confirmed diagnosis of rheumatoid arthritis
- Able to read, write and understand Turkish
Who cannot join
- Have cognitive impairment affecting ability to understand and complete the study questionnaire.
- Altered their disease-modifying medication regimen in the last 3 months
- Have another neurological or psychiatric diseases that effects daily living activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation of Evaluation of Daily Activity Questionnaire (EDAQ) Into Turkish, Examining The Reliability and Validity For People With Rheumatoid Arthritis
The aim of the study is to adapt the Evaluation of Daily Activity Questionnaire into Turkish language, and to examine the reliability and validity for people with rheumatoid arthritis.
Read the detailed description
Patient-Reported Outcome Measures are used in clinical practice and research to identify patients with rheumatic and musculoskeletal conditions' functional problems and evaluate the effectiveness of rehabilitation for these. Most commonly, daily activities in the International Classification of Functioning, Disability and Health (ICF) domains of communication, mobility, self-care and domestic life are assessed. Measurement tools commonly used in rheumatology out-patient clinics and research (e.g., the Health Assessment Questionnaire and the Arthritis Impact Measurement Scales 2 include too few activities to be of use for treatment planning. The Evaluation of Daily Activity Questionnaire was developed in the early 1990s in Sweden to address these problems. It is a patient-reported outcome measure evaluating common symptoms and measuring, in depth, activity limitations in rheumatoid arthritis. Patients normally complete it at home, allowing them time to reflect on their abilities and activity limitations. It normally takes between 25 and 35 min to complete.
Hammond et al have developed an English Evaluation of Daily Activity Questionnaire, which has been linguistically and culturally validated for use in the UK (from the original Swedish version). This was shown to be psychometrically robust for use with patients with rheumatoid arthritis. Subsequently, Hammond et al established the EDAQ's content validity and acceptability and demonstrated reliability and validity in seven other musculoskeletal conditions: ankylosing spondylitis; osteoarthritis; systemic lupus erythematosus; systemic sclerosis; chronic pain; chronic hand/upper limb musculoskeletal disorders; and primary Sjögren's syndrome. These conditions were selected as more often referred to occupational therapy. An EDAQ User Manual is available.
This questionnaire evaluates daily living activities of patients with arthritis and musculoskeletal conditions very comprehensively. Cross-cultural adaptation of the EDAQ into the Turkish language would enable its use in Turkey to identify the daily living activity problems for patients with rheumatoid arthritis. This questionnaire will be directional in clinical and academic studies.
The aim of the study is to adapt the Evaluation of Daily Activity Questionnaire into Turkish language, and to examine the reliability and validity for people with rheumatoid arthritis.
- Conditions
- Arthritis, Rheumatoid, Activities of Daily Living
- Being tested
- Adaptation into Turkish, Examining The Reliability and Validity for People with RA
- Keywords
- ADL, RA
- Medical subject headings
- Arthritis, Rheumatoid, Sarcoglycanopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptation into Turkish, Examining The Reliability and Validity for People with RAOther
Adaptation of Evaluation of Daily Activity Questionnaire into Turkish, examining the reliability and validity for people with rheumatoid arthritis
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis | To translate the EDAQ, which determines the difficulties experienced by individuals with rheumatoid arthritis in daily life, into Turkish. Receives: Other: Adaptation into Turkish, Examining The Reliability and Validity for People with RA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Daily Activities Questionnaire (EDAQ)
The Evaluation of Daily Activities Questionnaire (EDAQ) was developed to meet the needs of occupational therapists for a valid, reliable and detailed Patient Reported Outcome Measure. It is used in clinical practice in rheumatoid arthritis and other musculoskeletal diseases. It consists of 3 parts. Part 1 includes 10-point numeric rating scales that evaluate the common symptoms and effects of arthritis.Part 2 consists of 14 domains including 138 activities identified by people with rheumatoid arthritis as being often problematic. Twelve of these 14 domains can be combined to form some components: Self-Care, Mobility, Caring and Leisure/social activity. Part 2 corresponds to Activity and Participation in the ICF. Part 3 is optional and includes a checklist of assistive devices.
Measured: 45 minute
Health Assessment Questionnaire (HAQ)
The Health Assessment Questionnaire (HAQ) is an assessment tool created in 1980 to evaluate the daily and physical activities of rheumatoid arthritis patients. It is usually used with rheumatoid arthritis and osteoarthritis patients. The HAQ, which takes about 10 minutes to complete, is completed by the patient. The HAQ contains 20 items classified into eight domains. Items include daily activities such as dressing, eating, sitting up, hygiene, walking, grasping, reaching out. The questionnaire is scored with a 4-point Likert scale: "without any difficulty - 0", "with some difficulty - 1", "with much difficulty - 2", "unable to do - 3". The final score of the HAQ is the total item scores. The minimum possible total score is "0" and the maximum possible total score is "60". A higher score indicates greater disability.
Measured: 10 minute
Short Form-36 (SF-36v1)
Short Form 36v1 is a general health questionnaire that evaluates the perception of quality of life for the last four weeks in eight subcategories and 36 items: Physical functions, physical roles (role limitations because of physical condition), pain, social functions, mental health, emotional roles (role limitations because of emotional condition) energy and perception of general health. Two subgroups have "yes" and "no" answers, the other 6 subgroups use a Likert rating scale. Each subgroup is scored between 0 and 100, with a high score indicating good health. It is a generic measure, that is it can be used to measure and compare outcomes in different diseases and treatments, unlike disease-specific assessments (17). The Turkish SF36v1 has been shown to have good validity and reliability in patients with rheumatoid.
Measured: 15 minute
Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL)
The Rheumatoid Arthritis Quality of Life Questionnaire is a disease-specific scale developed for patients with rheumatoid arthritis and is a multidimensional quality of life scale. It consists of 30 questions answered as yes or no. Scores range from 0 to 30, with a high score indicating low quality of life.
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start30 Mar 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Other
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Büşra Kaplan, Alison Hammond, Fatma Gün, Özgün Belen, Remziye Akarsu, Gözde Kübra Yardımcı, Umut Kalyoncu, Mehmet Yusuf Çelik
- Responsible party
- Principal investigator, Gonca Bumin, Hacettepe University
- Investigators
- Gonca Bumin, Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244824
- Sponsor's protocol ID
- GO21/203
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Demographic and other socio-economic data will be collected and recorded, including age, gender, disease duration, employment status, marital status, living circumstances (alone; with significant others); number and age of children; and current medication. Because of the Covid-19 Pandemic and health and safety reasons, the sociodemographic information form, Evaluation of Daily Activity Questionnaire, Health Assessment Questionnaire, SF-36v1 and Rheumatoid Arthritis Quality of Life Questionnaire will be adapted into a Google form questionnaire. The questionnaire will be e-mailed to the participants with rheumatoid arthritis as a Google form questionnaire weblink. For those who do not have access to e-mail and the internet, a paper questionnaire option will be available by mail.
Publications
Hammond A, Tennant A, Tyson SF, Nordenskiold U, Hawkins R, Prior Y. The reliability and validity of the English version of the Evaluation of Daily Activity Questionnaire for people with rheumatoid arthritis. Rheumatology (Oxford). 2015 Sep;54(9):1605-15. doi: 10.1093/rheumatology/kev008. Epub 2015 Apr 10.
PubMed 25863045Hammond A, Meesters J, Niedermann K, Tennant A, Vliet Vlieland T, Tyson S, Nordenskiold U. Cross-cultural adaptation and psychometric testing of the Dutch and German versions of the Evaluation of Daily Activity Questionnaire in people with rheumatoid arthritis. Rheumatol Int. 2021 May;41(5):951-964. doi: 10.1007/s00296-020-04657-7. Epub 2020 Jul 26.
PubMed 32715341Hammond A, Tyson S, Prior Y, Hawkins R, Tennant A, Nordenskiold U, Thyberg I, Sandqvist G, Cederlund R. Linguistic validation and cultural adaptation of an English version of the evaluation of daily activity questionnaire in rheumatoid arthritis. Health Qual Life Outcomes. 2014 Sep 20;12:143. doi: 10.1186/s12955-014-0143-y.
PubMed 25238819Adroher ND, Tennant A. Supporting construct validity of the Evaluation of Daily Activity Questionnaire using Linear Logistic Test Models. Qual Life Res. 2019 Jun;28(6):1627-1639. doi: 10.1007/s11136-019-02146-4. Epub 2019 Mar 9.
PubMed 30852765
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Evaluation of Daily Activity Questionnaire (EDAQ) Into Turkish, Examining The Reliability and Validity For People With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05244824
- Acronym / sponsor ID
- GO21/203
- Conditions
- Arthritis, Rheumatoid, Activities of Daily Living
- Keywords
- ADL, RA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Büşra Kaplan, Alison Hammond, Fatma Gün, Özgün Belen, Remziye Akarsu, Gözde Kübra Yardımcı, Umut Kalyoncu, Mehmet Yusuf Çelik
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 17 Feb 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.
The aim of the study is to adapt the Evaluation of Daily Activity Questionnaire into Turkish language, and to examine the reliability and validity for people with rheumatoid arthritis.
Detailed description
Patient-Reported Outcome Measures are used in clinical practice and research to identify patients with rheumatic and musculoskeletal conditions' functional problems and evaluate the effectiveness of rehabilitation for these. Most commonly, daily activities in the International Classification of Functioning, Disability and Health (ICF) domains of communication, mobility, self-care and domestic life are assessed. Measurement tools commonly used in rheumatology out-patient clinics and research (e.g., the Health Assessment Questionnaire and the Arthritis Impact Measurement Scales 2 include too few activities to be of use for treatment planning. The Evaluation of Daily Activity Questionnaire was developed in the early 1990s in Sweden to address these problems. It is a patient-reported outcome measure evaluating common symptoms and measuring, in depth, activity limitations in rheumatoid arthritis. Patients normally complete it at home, allowing them time to reflect on their abilities and activity limitations. It normally takes between 25 and 35 min to complete.
Hammond et al have developed an English Evaluation of Daily Activity Questionnaire, which has been linguistically and culturally validated for use in the UK (from the original Swedish version). This was shown to be psychometrically robust for use with patients with rheumatoid arthritis. Subsequently, Hammond et al established the EDAQ's content validity and acceptability and demonstrated reliability and validity in seven other musculoskeletal conditions: ankylosing spondylitis; osteoarthritis; systemic lupus erythematosus; systemic sclerosis; chronic pain; chronic hand/upper limb musculoskeletal disorders; and primary Sjögren's syndrome. These conditions were selected as more often referred to occupational therapy. An EDAQ User Manual is available.
This questionnaire evaluates daily living activities of patients with arthritis and musculoskeletal conditions very comprehensively. Cross-cultural adaptation of the EDAQ into the Turkish language would enable its use in Turkey to identify the daily living activity problems for patients with rheumatoid arthritis. This questionnaire will be directional in clinical and academic studies.
The aim of the study is to adapt the Evaluation of Daily Activity Questionnaire into Turkish language, and to examine the reliability and validity for people with rheumatoid arthritis.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | – | Other: Adaptation into Turkish, Examining The Reliability and Validity for People with RATo translate the EDAQ, which determines the difficulties experienced by individuals with rheumatoid arthritis in daily life, into Turkish. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Since the Rasch analysis was used to evaluate the construct validity, it was determined that regardless of whether the scale was targeted well or not and considering the 99% confidence probability that item estimation was sufficient, a sample size of at least 210 should be taken, and 80 people should be taken for test-retest reliability.
Key inclusion criteria (3 listed)
- Being 18 years of age and older
- A confirmed diagnosis of rheumatoid arthritis
- Able to read, write and understand Turkish
Key exclusion criteria (3 listed)
- Have cognitive impairment affecting ability to understand and complete the study questionnaire.
- Altered their disease-modifying medication regimen in the last 3 months
- Have another neurological or psychiatric diseases that effects daily living activities
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 |
|---|---|---|
| Adaptation into Turkish, Examining The Reliability and Validity for People with RAAdaptation of Evaluation of Daily Activity Questionnaire into Turkish, examining the reliability and validity for people with rheumatoid arthritis | Other | Rheumatoid Arthritis |
Primary outcome
Evaluation of Daily Activities Questionnaire (EDAQ)
Time frame: 45 minute
The Evaluation of Daily Activities Questionnaire (EDAQ) was developed to meet the needs of occupational therapists for a valid, reliable and detailed Patient Reported Outcome Measure. It is used in clinical practice in rheumatoid arthritis and other musculoskeletal diseases. It consists of 3 parts. Part 1 includes 10-point numeric rating scales that evaluate the common symptoms and effects of arthritis.Part 2 consists of 14 domains including 138 activities identified by people with rheumatoid arthritis as being often problematic. Twelve of these 14 domains can be combined to form some components: Self-Care, Mobility, Caring and Leisure/social activity. Part 2 corresponds to Activity and Participation in the ICF. Part 3 is optional and includes a checklist of assistive devices.
Health Assessment Questionnaire (HAQ)
Time frame: 10 minute
The Health Assessment Questionnaire (HAQ) is an assessment tool created in 1980 to evaluate the daily and physical activities of rheumatoid arthritis patients. It is usually used with rheumatoid arthritis and osteoarthritis patients. The HAQ, which takes about 10 minutes to complete, is completed by the patient. The HAQ contains 20 items classified into eight domains. Items include daily activities such as dressing, eating, sitting up, hygiene, walking, grasping, reaching out. The questionnaire is scored with a 4-point Likert scale: "without any difficulty - 0", "with some difficulty - 1", "with much difficulty - 2", "unable to do - 3". The final score of the HAQ is the total item scores. The minimum possible total score is "0" and the maximum possible total score is "60". A higher score indicates greater disability.
Short Form-36 (SF-36v1)
Time frame: 15 minute
Short Form 36v1 is a general health questionnaire that evaluates the perception of quality of life for the last four weeks in eight subcategories and 36 items: Physical functions, physical roles (role limitations because of physical condition), pain, social functions, mental health, emotional roles (role limitations because of emotional condition) energy and perception of general health. Two subgroups have "yes" and "no" answers, the other 6 subgroups use a Likert rating scale. Each subgroup is scored between 0 and 100, with a high score indicating good health. It is a generic measure, that is it can be used to measure and compare outcomes in different diseases and treatments, unlike disease-specific assessments (17). The Turkish SF36v1 has been shown to have good validity and reliability in patients with rheumatoid.
Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL)
Time frame: 10 minute
The Rheumatoid Arthritis Quality of Life Questionnaire is a disease-specific scale developed for patients with rheumatoid arthritis and is a multidimensional quality of life scale. It consists of 30 questions answered as yes or no. Scores range from 0 to 30, with a high score indicating low quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Results publication: PubMed 25863045Hammond A, Tennant A, Tyson SF, Nordenskiold U, Hawkins R, Prior Y. The reliability and validity of the English version of the Evaluation of Daily Activity Questionnaire for people with rheumatoid arthritis. Rheumatology (Oxford). 2015 Sep;54(9):1605-15. doi: 10.1093/rheumatology/kev008. Epub 2015 Apr 10.
- Results publication: PubMed 32715341Hammond A, Meesters J, Niedermann K, Tennant A, Vliet Vlieland T, Tyson S, Nordenskiold U. Cross-cultural adaptation and psychometric testing of the Dutch and German versions of the Evaluation of Daily Activity Questionnaire in people with rheumatoid arthritis. Rheumatol Int. 2021 May;41(5):951-964. doi: 10.1007/s00296-020-04657-7. Epub 2020 Jul 26.
- Results publication: PubMed 25238819Hammond A, Tyson S, Prior Y, Hawkins R, Tennant A, Nordenskiold U, Thyberg I, Sandqvist G, Cederlund R. Linguistic validation and cultural adaptation of an English version of the evaluation of daily activity questionnaire in rheumatoid arthritis. Health Qual Life Outcomes. 2014 Sep 20;12:143. doi: 10.1186/s12955-014-0143-y.
- Results publication: PubMed 30852765Adroher ND, Tennant A. Supporting construct validity of the Evaluation of Daily Activity Questionnaire using Linear Logistic Test Models. Qual Life Res. 2019 Jun;28(6):1627-1639. doi: 10.1007/s11136-019-02146-4. Epub 2019 Mar 9.
- Individual participant dataSharing planned: No. Demographic and other socio-economic data will be collected and recorded, including age, gender, disease duration, employment status, marital status, living circumstances (alone; with significant others); number and age of children; and current medication. Because of the Covid-19 Pandemic and health and safety reasons, the sociodemographic information form, Evaluation of Daily Activity Questionnaire, Health Assessment Questionnaire, SF-36v1 and Rheumatoid Arthritis Quality of Life Questionnaire will be adapted into a Google form questionnaire. The questionnaire will be e-mailed to the participants with rheumatoid arthritis as a Google form questionnaire weblink. For those who do not have access to e-mail and the internet, a paper questionnaire option will be available by mail.
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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.
Gonca Bumin, Prof principal investigator
Hacettepe University
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 Arthritis, Rheumatoid and Activities of Daily Living, run by Hacettepe 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 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 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?
Results are not available in the source record.
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?
Evaluation of Daily Activities Questionnaire (EDAQ) (time frame: 45 minute). 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?
On the ClinicalTrials.gov record for NCT05244824, which also lists 4 linked publications.
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 17 Feb 2022.