PROM Collected Via a WebApp Versus a Touch Screen Solution Among Patients With SLE
30 mars 2021 uppdaterad av: Salome Kristensen
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
34
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Aalborg, Danmark, 9000
- Department of Rheumatology
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 110 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Group WT
PROM registration via the DANBIO WebApp and thereafter the outpatient touchscreen
|
PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
|
|
Övrig: Group TW
PROM registration via the outpatient touchscreen and thereafter the DANBIO WebApp
|
PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Systemic Lupus Activity Questionnaire global health
Tidsram: 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.
|
Day 1 (first data registration) and day 3 (second data registration)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Health Assessment Questionnaire (HAQ)
Tidsram: Day 1 (first data registration) and day 3 (second data registration)
|
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
Tidsram: Day 1 (first data registration) and day 3 (second data registration)
|
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
Tidsram: Day 1 (first data registration) and day 3 (second data registration)
|
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
Tidsram: Day 1 (first data registration) and day 3 (second data registration)
|
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)
Tidsram: Day 1 (first data registration) and day 3 (second data registration)
|
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
Tidsram: Day 1 (first data registration) and day 3 (second data registration)
|
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
Tidsram: Day 1 (first data registration) and day 3 (second data registration)
|
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
Tidsram: Day 1 (first data registration) and day 3 (second data registration)
|
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
Tidsram: Day 1 (first data registration) and day 3 (second data registration)
|
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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Salome Kristensen, MD, PhD, Department of Rheumatology, Aalborg University Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 juli 2020
Primärt slutförande (Faktisk)
25 november 2020
Avslutad studie (Faktisk)
25 november 2020
Studieregistreringsdatum
Först inskickad
28 maj 2020
Först inskickad som uppfyllde QC-kriterierna
28 maj 2020
Första postat (Faktisk)
2 juni 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 april 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 mars 2021
Senast verifierad
1 mars 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20200527
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Will be made available when the article is published
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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