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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04411407
Other study ID # 20200527
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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