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

Salome Kristensen

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Device: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order

Study type: Interventional

Funder types: Other

Identifiers

NCT04411407

20200527

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed in DANBIO with SLE
• Experience with the PROM questionnaires in DANBIO (≥ 1 previous assessments)

Exclusion criteria

• Inability to provide informed consent or to comply with the study protocol
• Diagnosis of SLE of ≥ 12 months
• Does not have access to a device that can run the DANBIO webapp

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Group WT

Other group

Description:

PROM registration via the DANBIO WebApp and thereafter the outpatient touchscreen

Treatment:

Device: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order

Group TW

Other group

Description:

PROM registration via the outpatient touchscreen and thereafter the DANBIO WebApp

Treatment:

Device: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order