No registrations found.
ID
Source
Health condition
Rheumatoid arthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Asscociation of optical score of the Handscan with DAS 28 and changes in medication
Secondary outcome
DAS 44
Assessment of the current complaints of different domains.
HAQ
MHOQ: Michigan hand outcome questionnaire
The extent of erosions at begin and end of the study (modified Sharp-van der Heijde score).
All RA-related admissions and adverse events.
Background summary
Prospective blinded observational study (registry) investigating the additive value of the diffuse optical imaging (the Handscan) to daily clinical practice in patients with rheumatoid arthritis. We will perform a blinded Handscan in a large group of RA patients during two years. After two years we will investigate the association of Handscan and different disease activity scores and the predictive value for help in clinical decision making such as changes in medication.
Study objective
The Handscan is supposed to be more accurate than the current widely used DAS 28, it might be able to measure subclinical disease activity.
We want to investigate in which clinical situation, the handscan can be an aide in decision making or can be used as a subtitute for health care professionals.
Study design
Follow up of patients with RA for a period of two years. A handscan will be made every regular visit before going to the health professional.
Intervention
None
Inclusion criteria
RA diagnosis according to ACR/EULAR criteria with at least two years duration.
Age> 18 years.
Able to place the hands flat on the scan plate.
Voluntary contribution in the study.
Able to give an informed consent.
Exclusion criteria
Hypersensitivity to light.
Hand surgery in the last month before inclusion.
Patient who can’t full the questionnaire with out help
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7500 |
| Other | METC MCL/ CCMO : nWMO257 |