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

Not Applicable

Completed

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT04411407
• Lead Sponsor: Salome Kristensen

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.

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-02
• Study Start: 2020-07-15
• Primary Completion: 2020-11-25
• Study Completion: 2020-11-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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?"
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.
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.

Trial Locations

Locations (1)

Department of Rheumatology; 🇩🇰 Aalborg, Denmark