NCT06568029Completed
Construct Validity and Responsiveness of EQ-5D-3L in Patients With Rheumatic Disease
Source: ClinicalTrials.gov · Last updated 6 Mar 2025
Brief summary (registry, in English)
The aim of this study is to investigate the construct validity (convergent and known-groups) and responsiveness of EQ-5D-3L in patients with rheumatoid arthritis, polyarthritis, psoriatic arthritis, and ankylosing spondylitis. The study is based on retrospective registry data from the Swedish Rheumatology Registry (SRQ).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 77651 (actual)
- First submitted
- 19 Aug 2024
- Start date
- 16 Aug 2024
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Karolinska Institutet
- NCT number
- NCT06568029
What you commit to
- Study type: Observational
- Participants enrolled: 77651
- From 16 Aug 2024 to the primary completion date, 30 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 18 years and older at the time of first included measurement
- A diagnosis of RA, polyarthritis, PsA, or AS
- Complete registration of responses in the EQ-5D-3L descriptive system or EQ VAS on at least one time point in SRQ
- For patients with RA: At least one measurement with Disease Activity Score 28 (DAS28) reported in relation to the same visit as EQ-5D-3L
- For patients with polyarthritis: At least one measurement with DAS28 reported in relation to the same visit as EQ-5D-3L
- For patients with PsA: At least one measurement with DAS28 or Disease Activity in Psoriatic Arthritis (DAPSA) reported in relation to the same visit as EQ-5D-3L
- For patients with AS: At least one measurement with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) reported in relation to the same visit as EQ-5D-3L
- For the analyses of construct validity, the latest measurement will be used if the individual patients have multiple complete registrations with EQ-5D-3L and the other required measure. The hypotheses for responsiveness will be tested in patients with newly diagnosed disease (having the diagnosis for ≤12 months), as changes in disease activity are likely to be present in this group. For the analysis of responsiveness, the two first measurements during the first year will be used.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| It is an observational study based on the The Swedish Rheumatology Quality Register Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.