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RecruitingNCT06068920Updated Oct 5, 2023

Distress in Rheumatoid Arthritis Patients

An observational study in Arthritis, Rheumatoid and Distress, Emotional, sponsored by Bozyaka Training and Research Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Bozyaka Training and Research Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
90
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 126 studies in Arthritis, Rheumatoid with a site in Turkey — 14 open to participants now, 19 under way, 2 of them phase 3. Arthritis, Rheumatoid · Turkey.

Planned enrollment
29th of 49
90 · median 100
Started
2023
with 17 others
Observational
49 of 126
9 open now
Primary completion
2023-11
later than 2 of 18 live
Registered
83rd of 126
by date

Among the 126 studies in Arthritis, Rheumatoid with a site in Turkey, this one is the 29th largest by planned enrollment of the 49 observational ones, is one of 18 that started in 2023, is one of 49 observational ones, reaches primary completion later than 2 of the 18 other live ones, and was the 83rd registered.

By phase

126 studies; the count open now beside each. This study's row is marked.

Observationalthis study49 · 9 open
No phase43 · 5 open
Phase 318 · 0 open
Phase 47 · 0 open
Phase 26 · 0 open
Phase 2/32 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2001; this study’s year is marked. 18 started in 2023.

Size and results

Median enrollment 80 across the 77 interventional studies, 100 across the 49 observational. Of the 97 that completed or were terminated, 31 (32%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 126 studies in Arthritis, Rheumatoid with a site in Turkey, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Arthritis, Rheumatoid
  • Distress, Emotional

Keywords

  • rheumatoid arthritis, distress
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Patient registry
No

Interventions

  • OtherDistress evaluation

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

06

What researchers measure

Primary outcomes

  1. Distress

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

    Time frame: 10 months

Secondary outcomes

  1. Disease activity

    Disease activity will be evaluated by DAS 28 score.

    Time frame: 10 months

  2. Functional status

    Functional status of patients will be evaluated by HAQ.

    Time frame: 10 months

07

Study locations

1 of 1 sites recruiting
  • University of Health Sciences Turkey
    İzmir, Turkey
    Recruiting
08

References and documents

Publications

  • 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. PubMed 24003249 ↗
  • 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. PubMed 20669340 ↗
  • 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. PubMed 27345064 ↗
  • 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. PubMed 34782021 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2023 (actual). Primary completion is estimated for Nov 2023, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2023
First posted
Oct 5, 2023
StartActual
Jan 30, 2023
Primary completionEst.
Nov 2023
CompletionEst.
Dec 1, 2023
Last update
Oct 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06068920
Lead sponsor
Bozyaka Training and Research Hospital
Responsible party
Altınay Göksel Karatepe (Professor Doctor, Bozyaka Training and Research Hospital) — Principal investigator
First posted
Oct 5, 2023
Start date
Jan 30, 2023
Primary completion
Nov 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Oct 5, 2023

Study contacts

Altınay Göksel Karatepe, MD
principal investigator · Professor doctor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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