Clinical trial NCT05244824: Adaptation of EDAQ Into Turkish, Examining The Reliability and Validity For People With RA
Official title: Adaptation of Evaluation of Daily Activity Questionnaire (EDAQ) Into Turkish, Examining The Reliability and Validity For People With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis, Rheumatoid
Activities of Daily Living
Keywords: ADL, RA
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Büşra Kaplan
name: Alison Hammond
name: Fatma Gün
name: Özgün Belen
name: Remziye Akarsu
name: Gözde Kübra Yardımcı
name: Umut Kalyoncu
name: Mehmet Yusuf Çelik
First posted: 2022-02-17
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Being 18 years of age and older
* A confirmed diagnosis of rheumatoid arthritis
* Able to read, write and understand Turkish

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of Daily Activities Questionnaire (EDAQ)
timeFrame: 45 minute
measure: Health Assessment Questionnaire (HAQ)
timeFrame: 10 minute
measure: Short Form-36 (SF-36v1)
timeFrame: 15 minute
measure: Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL)
timeFrame: 10 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Çankaya
Study officials:
affiliation: Hacettepe University
name: Gonca Bumin, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hammond 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.
citation: Hammond 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.
citation: Adroher 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.