Distress in Rheumatoid Arthritis Patients

Sponsor
Bozyaka Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06068920
Collaborator
(none)
90
1
10
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Distress evaluation

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 Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Distress and Related Factors in Patients With Rheumatoid Arthritis
Actual Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Distress [10 months]

    Presence of distress related with rheumatoid arthritis will be evaluated by Rheumatoid Arthritis Distress Scale.

Secondary Outcome Measures

  1. Disease activity [10 months]

    Disease activity will be evaluated by DAS 28 score.

  2. Functional status [10 months]

    Functional status of patients will be evaluated by HAQ.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Health Sciences Turkey İzmir Turkey

Sponsors and Collaborators

  • Bozyaka Training and Research Hospital

Investigators

  • Principal Investigator: Altınay Göksel Karatepe, MD, Professor doctor

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Altınay Göksel Karatepe, Professor Doctor, Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT06068920
Other Study ID Numbers:
  • IBEAH
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Sep 1, 2023
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 Altınay Göksel Karatepe, Professor Doctor, Bozyaka Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2023