Adaptation of EDAQ Into Turkish, Examining The Reliability and Validity For People With RA

Arthritis, Rheumatoid Clinical Trial

Official title:

Adaptation of Evaluation of Daily Activity Questionnaire (EDAQ) Into Turkish, Examining The Reliability and Validity For People With Rheumatoid Arthritis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05244824
• Other study ID #: GO21/203
• Status: Enrolling by invitation
• Start date: March 30, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 210
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Activities of Daily Living
• Arthritis
• Arthritis, Rheumatoid

Intervention

Other:
• Adaptation into Turkish, Examining The Reliability and Validity for People with RA
Adaptation of Evaluation of Daily Activity Questionnaire into Turkish, examining the reliability and validity for people with rheumatoid arthritis

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Çankaya

Sponsors (9)

Lead Sponsor	Collaborator
Hacettepe University	Alison Hammond, Büsra Kaplan, Fatma Gün, Gözde Kübra Yardimci, Mehmet Yusuf Çelik, Özgün Belen, Remziye Akarsu, Umut Kalyoncu

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Hammond A, Meesters J, Niedermann K, Tennant A, Vliet Vlieland T, Tyson S, Nordenskiöld U. Cross-cultural adaptation and psychometric testing of the Dutch and German versions of the Evaluation of Daily Activity Questionnaire in people with rheumatoid arth — View Citation

Hammond A, Tennant A, Tyson SF, Nordenskiöld 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. — View 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 Q — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	45 minute
Primary	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.	10 minute
Primary	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.	15 minute
Primary	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.	10 minute

External Links

•   EDAQ Manual v3