Distress in Rheumatoid Arthritis Patients | NCT06068920

Studies
Distress in Rheumatoid Arthritis Patients

NCT06068920

Sponsor

Bozyaka Training and Research Hospital

Status

Unknown status

Last Update Posted

Oct 5, 2023Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Arthritis, Rheumatoid
Distress, Emotional

Interventions

Distress evaluation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2023Actual

Primary Completion Date

Nov 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Sep 29, 2023

First Submission Date that Met QC Criteria

Sep 29, 2023

First Posted Date

Oct 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2023

Last Update Posted Date

Oct 5, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Altınay Göksel Karatepe, Professor Doctor, Bozyaka Training and Research HospitalPrincipal Investigator

Lead Sponsor

Bozyaka Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Distress evaluation	Other	To evaluate the effects of psychological distress caused by living with a chronic disease such as rheumatoid arthritis.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Distress	Presence of distress related with rheumatoid arthritis will be evaluated by Rheumatoid Arthritis Distress Scale.	10 months

Secondary Outcomes

Measure	Description	Time Frame
Disease activity	Disease activity will be evaluated by DAS 28 score.	10 months
Functional status	Functional status of patients will be evaluated by HAQ.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Altınay Göksel Karatepe, MD	Professor doctor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Health Sciences Turkey	Recruiting	Izmir			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24003249	Background	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.
20669340	Background	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.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases