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Completed

NCT Number: NCT04411407

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rheumatology

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Health Assessment Questionnaire (HAQ)

    Time frame: 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.

  2. Visual Analogue Scale for Pain

    Time frame: 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.

  3. Visual Analogue Scale for fatigue

    Time frame: 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.

  4. Patient Global Visual Analogue Scale

    Time frame: 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.

  5. Patient Acceptable Symptom State (PASS)

    Time frame: 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?"

  6. Anchoring question

    Time frame: 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.

  7. SLAQ flare score

    Time frame: 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).

  8. SLAQ symptom score

    Time frame: 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.

  9. SLAQ total score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Salome Kristensen

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2020
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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