Clinical trial NCT04411407: PROM Collected Via a WebApp Versus a Touch Screen Solution Among Patients With SLE
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomised, within-participants, open, cross-over trial
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Systemic Lupus Activity Questionnaire global health
timeFrame: Day 1 (first data registration) and day 3 (second data registration)
Secondary outcomes:
measure: Change in Health Assessment Questionnaire (HAQ)
timeFrame: Day 1 (first data registration) and day 3 (second data registration)
measure: Visual Analogue Scale for Pain
timeFrame: Day 1 (first data registration) and day 3 (second data registration)
measure: Visual Analogue Scale for fatigue
timeFrame: Day 1 (first data registration) and day 3 (second data registration)
measure: Patient Global Visual Analogue Scale
timeFrame: Day 1 (first data registration) and day 3 (second data registration)
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Day 1 (first data registration) and day 3 (second data registration)
measure: Anchoring question
timeFrame: Day 1 (first data registration) and day 3 (second data registration)
measure: SLAQ flare score
timeFrame: Day 1 (first data registration) and day 3 (second data registration)
measure: SLAQ symptom score
timeFrame: Day 1 (first data registration) and day 3 (second data registration)
measure: SLAQ total score
timeFrame: Day 1 (first data registration) and day 3 (second data registration)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Rheumatology
Study officials:
affiliation: Department of Rheumatology, Aalborg University Hospital
name: Salome Kristensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: