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

Sponsor
Hacettepe University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05244824
Collaborator
Büşra Kaplan (Other), Alison Hammond (Other), Fatma Gün (Other), Özgün Belen (Other), Remziye Akarsu (Other), Gözde Kübra Yardımcı (Other), Umut Kalyoncu (Other), Mehmet Yusuf Çelik (Other)
210
1
15
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Adaptation into Turkish, Examining The Reliability and Validity for People with RA

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

Study Type:
Observational
Anticipated Enrollment :
210 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Adaptation of Evaluation of Daily Activity Questionnaire (EDAQ) Into Turkish, Examining The Reliability and Validity For People With Rheumatoid Arthritis
Actual Study Start Date :
Mar 30, 2021
Anticipated Primary Completion Date :
Mar 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Rheumatoid Arthritis

To translate the EDAQ, which determines the difficulties experienced by individuals with rheumatoid arthritis in daily life, into Turkish.

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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of Daily Activities Questionnaire (EDAQ) [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.

  2. Health Assessment Questionnaire (HAQ) [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.

  3. Short Form-36 (SF-36v1) [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.

  4. Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Ankara Çankaya Turkey

Sponsors and Collaborators

  • Hacettepe University
  • Büşra Kaplan
  • Alison Hammond
  • Fatma Gün
  • Özgün Belen
  • Remziye Akarsu
  • Gözde Kübra Yardımcı
  • Umut Kalyoncu
  • Mehmet Yusuf Çelik

Investigators

  • Principal Investigator: Gonca Bumin, Prof, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Gonca Bumin, Prof. Dr., Hacettepe University
ClinicalTrials.gov Identifier:
NCT05244824
Other Study ID Numbers:
  • GO21/203
First Posted:
Feb 17, 2022
Last Update Posted:
Feb 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gonca Bumin, Prof. Dr., Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2022