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

30. marts 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

34

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Aalborg, Danmark, 9000
        • Department of rheumatology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 110 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Group WT
PROM registration via the DANBIO WebApp and thereafter the outpatient touchscreen
Enhed: 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
Andet: Group TW
PROM registration via the outpatient touchscreen and thereafter the DANBIO WebApp
Enhed: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Systemic Lupus Activity Questionnaire global health
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Health Assessment Questionnaire (HAQ)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Salome Kristensen

Efterforskere

  • Ledende efterforsker: Salome Kristensen, MD, PhD, Department of Rheumatology, Aalborg University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juli 2020

Primær færdiggørelse (Faktiske)

25. november 2020

Studieafslutning (Faktiske)

25. november 2020

Datoer for studieregistrering

Først indsendt

28. maj 2020

Først indsendt, der opfyldte QC-kriterier

28. maj 2020

Først opslået (Faktiske)

2. juni 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20200527

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Will be made available when the article is published

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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