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NCT06068920 Clinical Trial

Distress in Rheumatoid Arthritis Patients

Arthritis, Rheumatoid Clinical Trial

Official title:
Evaluation of Distress and Related Factors in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06068920
Other study ID # IBEAH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2023
Est. completion date December 1, 2023

Study information
Verified date September 2023
Source Bozyaka Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to determine the frequency of psychological distress caused by the rheumatoid arthritis disease in patients with rheumatoid arthritis and to determine the factors associated with the distress. A routine rheumatoid arthritis patient examination (number of swollen and tender joints, disease activity, functional status, etc.) will be performed by the doctor to evaluate the patients. Patients will be asked to fill out the questionnaires to evaluate their functional status and distress levels. Demographic data such as age, gender, body mass index and disease duration will be recorded during routine follow-up of the patients. The duration of morning stiffness, the number of swollen and tender joints, disease activity and functional status will be evaluated by the doctor. Disease activity will be evaluated with the DAS 28 score and functional status will be evaluated with the Health Assessment Questionnaire. Rheumatoid Arthritis Distress Scale (RADS) will be used to evaluate the distress due to rheumatoid arthritis.Patients will be asked to fill out the questionnaires to evaluate their functional status and distress levels.

Description:

Demographic data such as age, gender, body mass index and disease duration will be recorded during routine follow-up of the patients. The duration of morning stiffness, the number of swollen and tender joints, disease activity and functional status will be evaluated by the doctor. Disease activity will be evaluated with the DAS 28 score and functional status will be evaluated with the Health Assessment Questionnaire. Rheumatoid Arthritis Distress Scale (RADS) will be used to evaluate the distress due to rheumatoid arthritis. DAS28 score is a score calculated by a mathematical formula based on the patient's swollen and tender joint counts, erythrocyte sedimentation rate and the patient's global assessment of disease activity. The Health Assessment Questionnaire consists of twenty items and evaluates the degree of difficulty patients have in performing daily living activities. The total score varies between 0 and 3, with a higher score indicating a more serious impact on daily functional status. Rheumatoid Arthritis Distress Scale (RADS) is a scale developed to evaluate the psychological distress experienced in patients with rheumatoid arthritis due to the effects of the disease. The total score varies between 0 and 5, with a higher score indicating more impact.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date December 1, 2023
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Having rheumatoid arthritis over the age of 18 2. Having the cognitive state to understand what you read and answer questions Exclusion Criteria: 1. Being currently receiving treatment for known psychological disorders such as depression and anxiety. 2. Having another chronic disease that may cause psychological distress

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Distress evaluation
To evaluate the effects of psychological distress caused by living with a chronic disease such as rheumatoid arthritis.

Locations
Country Name City State
Turkey University of Health Sciences Turkey Izmir

Sponsors (1)
Lead Sponsor Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Book K, Marten-Mittag B, Henrich G, Dinkel A, Scheddel P, Sehlen S, Haimerl W, Schulte T, Britzelmeir I, Herschbach P. Distress screening in oncology-evaluation of the Questionnaire on Distress in Cancer Patients-short form (QSC-R10) in a German sample. Psychooncology. 2011 Mar;20(3):287-93. doi: 10.1002/pon.1821. — View Citation

Matcham F, Rayner L, Steer S, Hotopf M. The prevalence of depression in rheumatoid arthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2013 Dec;52(12):2136-48. doi: 10.1093/rheumatology/ket169. Epub 2013 Sep 3. — View Citation

Silke L, Kirresh O, Sturt J, Lempp H. Development of the Rheumatoid Arthritis Distress Scale (RADS): a new tool to identify disease-specific distress in patients with Rheumatoid Arthritis. BMC Rheumatol. 2021 Nov 16;5(1):51. doi: 10.1186/s41927-021-00220-4. — View Citation

Woodward S, Dibley L, Coombes S, Bellamy A, Clark C, Czuber-Dochan W, Everelm L, Kutner S, Sturt J, Norton C. Identifying disease-specific distress in patients with inflammatory bowel disease. Br J Nurs. 2016 Jun 23;25(12):649-60. doi: 10.12968/bjon.2016.25.12.649. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Distress Presence of distress related with rheumatoid arthritis will be evaluated by Rheumatoid Arthritis Distress Scale. 10 months
Secondary Disease activity Disease activity will be evaluated by DAS 28 score. 10 months
Secondary Functional status Functional status of patients will be evaluated by HAQ. 10 months
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