NCT04411407

PROM Collected Via a WebApp Versus a Touch Screen Solution Among Patients With SLE

Patient-reported Outcome Measures Collected in DANBIO Via a From Home Web Application Versus a Touchscreen in the Outpatient Clinic Among Patients With Systemic Lupus Erythematosus: A Randomised, Crossover, Agreement Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Salome Kristensen · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

A randomised, within-participants cross-over design trial including 34 patients with systemic lupus erythematosus. The participants will be randomised to data registration of patient reported outcome measures (PROM) through the DANBIO webapp and thereafter via the outpatient touchscreen or vice versa.

Detailed description

The aim of this trial is to evaluate whether electronic reporting of PROMs through the DANBIO web application (webapp) is comparable to the outpatient touchscreen among patients with SLE. The trial is a randomised, crossover, agreement study where 34 patients with SLE from the Department of Rheumatology at Aalborg University Hospital will be included and randomised in ratio 1:1 to: * Group 1: PROMs are reported through the DANBIO webapp; thereafter, the touchscreen. * Group 2: PROMs are reported through the touchscreen; thereafter, the DANBIO webapp. There will be a wash-out period of 1-2 day between the two registrations to minimise carryover bias.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DEVICE	PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order	PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order

Timeline

• Start date: 2020-07-15
• Primary completion: 2020-11-25
• Completion: 2020-11-25
• First posted: 2020-06-02
• Last updated: 2021-04-01

Locations

1 site across 1 country: Denmark