Distress in Rheumatoid Arthritis Patients

Recruiting

• Conditions: Distress, Emotional; Arthritis, Rheumatoid

• Registration Number: NCT06068920
• Lead Sponsor: Bozyaka Training and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-01-30
• Status Verified: 2023-09
• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-09-29
• Last Update Submitted: 2023-09-29
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05
• Primary Completion: 2023-11
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distress	10 months	Presence of distress related with rheumatoid arthritis will be evaluated by Rheumatoid Arthritis Distress Scale.

Secondary Outcome Measures

Name	Time	Method
Functional status	10 months	Functional status of patients will be evaluated by HAQ.
Disease activity	10 months	Disease activity will be evaluated by DAS 28 score.

Trial Locations

Locations (1)

University of Health Sciences Turkey; 🇹🇷 İzmir, Turkey