Systemic Lupus Erythematosus
Conditions
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.
Interventions
DEVICEPROM 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
Sponsors
Salome Kristensen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
A randomised, within-participants, open, cross-over trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systemic Lupus Activity Questionnaire global health | Day 1 (first data registration) and day 3 (second data registration) | Evaluates global assessment of lupus activity using an NRS score from 0-10. Higher score Means worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Assessment Questionnaire (HAQ) | Day 1 (first data registration) and day 3 (second data registration) | Assess the patient's physical function from 0-3. Higher score Means worse outcome. |
| Visual Analogue Scale for Pain | Day 1 (first data registration) and day 3 (second data registration) | 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. |
| Visual Analogue Scale for fatigue | Day 1 (first data registration) and day 3 (second data registration) | 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. |
| Patient Global Visual Analogue Scale | Day 1 (first data registration) and day 3 (second data registration) | 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. |
| Anchoring question | Day 1 (first data registration) and day 3 (second data registration) | The patient's assessment of change in arthritis activity since last visit from much worse to much better. |
| SLAQ flare score | Day 1 (first data registration) and day 3 (second data registration) | 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). |
| SLAQ symptom score | Day 1 (first data registration) and day 3 (second data registration) | Evaluates the number of lupus specific symptoms present from 0-24. Higher score means worse outcome. |
| SLAQ total score | Day 1 (first data registration) and day 3 (second data registration) | Evaluates severity of lupus disease activity by a weighted score of the 24 lupus specific symptoms, range 0-44. Higher score means worse outcome. |
| Patient Acceptable Symptom State (PASS) | Day 1 (first data registration) and day 3 (second data registration) | 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? |
Countries
Denmark
Outcome results
None listed