Overview

This trial is active, not recruiting.

Conditions rheumatoid arthritis, axial spondyloarthritis
Treatment reporting of patient reported outcome measures
Sponsor Henrik Gudbergsen
Collaborator The DANBIO registry, Denmark
Start date May 2016
End date September 2016
Trial size 40 participants
Trial identifier NCT02818478, 100.03

Summary

To investigate if electronic reporting of patient reported outcome measures from home is comparable to the traditional touch-screen solution to hospital among patients with rheumatoid arthritis and axial spondyloarthritis

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Arm
(Other)
Patients in this arm (10 patients with rheumatoid arthirtis, RA) will be randomised to initially fill in patient reported outcome measures from home via their own computer or tablet; subsequently these patients will fill in patient reported outcome measures at the outpatient clinic
reporting of patient reported outcome measures
Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic
(Other)
Patients in this arm (10 patients with rheumatoid arthirtis, RA) will be randomised to initially fill in patient reported outcome measures at the outpatient clinic; subsequently these patients will fill in patient reported outcome measures from home via their own computer or tablet
reporting of patient reported outcome measures
Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic
(Other)
Patients in this arm (10 patients with axial spondyloarthritis, AxSpa) will be randomised to initially fill in patient reported outcome measures from home via their own computer or tablet; subsequently these patients will fill in patient reported outcome measures at the outpatient clinic
reporting of patient reported outcome measures
Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic
(Other)
Patients in this arm (10 patients with axial spondyloarthritis, AxSpa) will be randomised to initially fill in patient reported outcome measures at the outpatient clinic; subsequently these patients will fill in patient reported outcome measures from home via their own computer or tablet
reporting of patient reported outcome measures
Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic

Primary Outcomes

Measure
HAQ
time frame: 48 hours

Secondary Outcomes

Measure
100 mm VAS global
time frame: 48 hours
100 mm VAS pain
time frame: 48 hours
100 mm VAS fatigue
time frame: 48 hours
BASDAI
time frame: 48 hours
BASFI
time frame: 48 hours
BASDAI 5 & 6
time frame: 48 hours

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria - Rheumatoid arthirtis OR axial spondyloarthritis - Active treatment and monitoring of the Knowledge Center for Rheumatology and Spine diseases, Rigshospitalet, Denmark - Patients must have reported patient reported outcome measures via DANBIOs touch-screen solution ≥ 3 times Exclusion Criteria - Impaired vision - Non-Danish speaking - No electronic device at home,, tablet or computer

Additional Information

Official title Patient Reported Outcome Measures Reported Into the Danish Arthritis Registry (DANBIO) Via Computer or Tablet at Home Versus Touch Screen at the Outpatient Clinic Among Patients With Axial Spondyloarthritis or Rheumatoid Arthritis
Principal investigator Merete M Hetland, MD.PhD.DMSc
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Parker Research Institute.