Systemic Lupus ErythematosusNCT04411407
PROM Collected Via a WebApp Versus a Touch Screen Solution Among Patients With SLE
A study testing PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order in people with Systemic Lupus Erythematosus, run by Salome Kristensen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jul 2020to 25 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed in DANBIO with SLE
- Experience with the PROM questionnaires in DANBIO (≥ 1 previous assessments)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Group WT | Other | PROM registration via the DANBIO WebApp and thereafter the outpatient touchscreen Receives: 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 Receives: Device: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (first data registration) and day 3 (second data registration)
Secondary outcomes (9)
Change in Health Assessment Questionnaire (HAQ)
Assess the patient's physical function from 0-3. Higher score Means worse outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?"
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 1 (first data registration) and day 3 (second data registration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start15 Jul 2020
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomised, within-participants, open, cross-over trial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salome Kristensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salome Kristensen, Aalborg University Hospital
- Investigators
- Salome Kristensen, MD, PhD, Principal investigator, Department of Rheumatology, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411407
- Sponsor's protocol ID
- 20200527
- Status last verified
- Mar 2021
- First submitted
- 28 May 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04411407
- Acronym / sponsor ID
- 20200527
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Salome KristensenUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomised, within-participants, open, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Group WT | Other | Device: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised orderPROM registration via the DANBIO WebApp and thereafter the outpatient touchscreen |
| Group TW | Other | Device: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised orderPROM registration via the outpatient touchscreen and thereafter the DANBIO WebApp |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed in DANBIO with SLE
- Experience with the PROM questionnaires in DANBIO (≥ 1 previous assessments)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised orderPROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order | Device | Group TW, Group WT |
Primary outcome
Change in Systemic Lupus Activity Questionnaire global health
Time frame: 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.
9 secondary outcomes
Change in Health Assessment Questionnaire (HAQ)
Time frame: Day 1 (first data registration) and day 3 (second data registration)
Visual Analogue Scale for Pain
Time frame: Day 1 (first data registration) and day 3 (second data registration)
Visual Analogue Scale for fatigue
Time frame: Day 1 (first data registration) and day 3 (second data registration)
Patient Global Visual Analogue Scale
Time frame: Day 1 (first data registration) and day 3 (second data registration)
Patient Acceptable Symptom State (PASS)
Time frame: Day 1 (first data registration) and day 3 (second data registration)
Anchoring question
Time frame: Day 1 (first data registration) and day 3 (second data registration)
SLAQ flare score
Time frame: Day 1 (first data registration) and day 3 (second data registration)
SLAQ symptom score
Time frame: Day 1 (first data registration) and day 3 (second data registration)
SLAQ total score
Time frame: Day 1 (first data registration) and day 3 (second data registration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salome Kristensen, MD, PhD principal investigator
Department of Rheumatology, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order in people with Systemic Lupus Erythematosus, run by Salome Kristensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systemic Lupus Activity Questionnaire global health (time frame: Day 1 (first data registration) and day 3 (second data registration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.