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

February 8, 2022 updated by: Gonca Bumin, Hacettepe University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45 minute
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.
10 minute
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.
15 minute
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.
10 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO21/203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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