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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411407
• Other study ID #: 20200527
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: November 25, 2020

Study information

• Verified date: March 2021
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Rheumatology	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Salome Kristensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)