NCT06068920

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 5, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 29, 2023

Last Update Submit

September 29, 2023

Conditions

Arthritis, RheumatoidDistress, Emotional

Keywords

rheumatoid arthritis, distress

Outcome Measures

Primary Outcomes (1)

  • Distress

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

    10 months

Secondary Outcomes (2)

  • Disease activity

    10 months

  • Functional status

    10 months

Interventions

Distress evaluationOTHER

To evaluate the effects of psychological distress caused by living with a chronic disease such as rheumatoid arthritis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18 years and older, diagnosed with rheumatoid arthritis.

You may qualify if:

  • Having rheumatoid arthritis over the age of 18
  • Having the cognitive state to understand what you read and answer questions

You may not qualify if:

  • Being currently receiving treatment for known psychological disorders such as depression and anxiety.
  • Having another chronic disease that may cause psychological distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Turkey

Izmir, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 24003249BACKGROUND

  • 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.

    PMID: 20669340BACKGROUND

  • 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.

    PMID: 27345064BACKGROUND

  • 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.

    PMID: 34782021BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Altınay Göksel Karatepe, MD

    Professor doctor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 5, 2023

Study Start

January 30, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

October 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)