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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
34
PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
Department of Rheumatology
Aalborg, Denmark
Change in Systemic Lupus Activity Questionnaire global health
Evaluates global assessment of lupus activity using an NRS score from 0-10. Higher score Means worse outcome.
Time frame: Day 1 (first data registration) and day 3 (second data registration)
Change in Health Assessment Questionnaire (HAQ)
Assess the patient's physical function from 0-3. Higher score Means worse outcome.
Time frame: Day 1 (first data registration) and day 3 (second data registration)
Visual Analogue Scale for Pain
The patient's assessment of pain on a scale from 0-100 within the last week.The left of the scale (0) signifies the absence of pain and the right end (100) maximum pain.
Time frame: Day 1 (first data registration) and day 3 (second data registration)
Visual Analogue Scale for fatigue
The patient's assessment of fatigue on a scale from 0-100 within the last week. The left of the scale (0) signifies the absence of fatigue and the right end (100) maximum fatigue.
Time frame: Day 1 (first data registration) and day 3 (second data registration)
Patient Global Visual Analogue Scale
The patient's global assessment of disease activity (arthritis severity) on a scale from 0-100 within the last week. The left of the scale (0) signifies the absence of arthritis activity and the right end (100) maximum arthritis activity.
Time frame: Day 1 (first data registration) and day 3 (second data registration)
Patient Acceptable Symptom State (PASS)
The patient's assessment of acceptable symptom state. Consist of one question answered with "yes" or "no". The question is: ''Take into account all the ways in which your arthritis has affected you in the past 48 hours. If you were to remain for the next few months as you are today, would it be acceptable to you?"
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Time frame: Day 1 (first data registration) and day 3 (second data registration)
Anchoring question
The patient's assessment of change in arthritis activity since last visit from much worse to much better.
Time frame: Day 1 (first data registration) and day 3 (second data registration)
SLAQ flare score
Evaluates presence or severity of lupus flare on a transitional scale e.g. 0 (no worsening), 1 (mild worsening), 2 (moderate worsening) or 3 (severe worsening).
Time frame: Day 1 (first data registration) and day 3 (second data registration)
SLAQ symptom score
Evaluates the number of lupus specific symptoms present from 0-24. Higher score means worse outcome.
Time frame: Day 1 (first data registration) and day 3 (second data registration)
SLAQ total score
Evaluates severity of lupus disease activity by a weighted score of the 24 lupus specific symptoms, range 0-44. Higher score means worse outcome.
Time frame: Day 1 (first data registration) and day 3 (second data registration)