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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Device: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomised, within-participants, open, cross-over trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group WT<br>PROM registration via the DANBIO WebApp and thereafter the outpatient touchscreen | Device: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order<br>* PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order<br>|
| Other: Group TW<br>PROM registration via the outpatient touchscreen and thereafter the DANBIO WebApp | Device: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order<br>* PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 (first data registration) and day 3 (second data registration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Assessment Questionnaire (HAQ) | Assess the patient's physical function from 0-3. Higher score Means worse outcome. | 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. | 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. | 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. | 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? | 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. | 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). | 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. | 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. | Day 1 (first data registration) and day 3 (second data registration) |