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

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Device: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Department of rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group WT; 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; PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
Other: Group TW; 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; PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Salome Kristensen
• Investigators: Principal Investigator: Salome Kristensen, MD, PhD, Department of Rheumatology, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): November 25, 2020
• Study Completion (Actual): November 25, 2020

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 20200527

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol and the SAP will be published as supplementary information to the article. IPD from this trial that underlie results in a publication will be made available in clinicaltrials.gov after publication of the article.
• IPD Sharing Time Frame: Will be made available when the article is published
• IPD Sharing Access Criteria: Study protocol and the SAP will be published as supplementary information to the article. IPD from this trial that underlie results in a publication will be made available in clinicaltrials.gov after publication of the article.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No