NCT04411407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2020

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

May 28, 2020

Last Update Submit

March 30, 2021

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change in Health Assessment Questionnaire (HAQ)

    Day 1 (first data registration) and day 3 (second data registration)

  • Visual Analogue Scale for Pain

    Day 1 (first data registration) and day 3 (second data registration)

  • Visual Analogue Scale for fatigue

    Day 1 (first data registration) and day 3 (second data registration)

  • Patient Global Visual Analogue Scale

    Day 1 (first data registration) and day 3 (second data registration)

  • Patient Acceptable Symptom State (PASS)

    Day 1 (first data registration) and day 3 (second data registration)

  • +4 more secondary outcomes

Study Arms (2)

Group WT

OTHER

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

Group TW

OTHER

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

Interventions

PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised orderDEVICE

PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order

Group TWGroup WT

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed in DANBIO with SLE
  • Experience with the PROM questionnaires in DANBIO (≥ 1 previous assessments)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Salome Kristensen, MD, PhD

    Department of Rheumatology, Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: A randomised, within-participants, open, cross-over trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician, PhD, Principal Investigator

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 2, 2020

Study Start

July 15, 2020

Primary Completion

November 25, 2020

Study Completion

November 25, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Will be made available when the article is published
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.

Locations

DK(1)