<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04411407</url>
  </required_header>
  <id_info>
    <org_study_id>20200527</org_study_id>
    <nct_id>NCT04411407</nct_id>
  </id_info>
  <brief_title>PROM Collected Via a WebApp Versus a Touch Screen Solution Among Patients With SLE</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Salome Kristensen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aalborg University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomised, within-participants cross-over design trial including 34 patients with systemic&#xD;
      lupus erythematosus. The participants will be randomised to data registration of patient&#xD;
      reported outcome measures (PROM) through the DANBIO webapp and thereafter via the outpatient&#xD;
      touchscreen or vice versa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this trial is to evaluate whether electronic reporting of PROMs through the DANBIO&#xD;
      web application (webapp) is comparable to the outpatient touchscreen among patients with SLE.&#xD;
&#xD;
      The trial is a randomised, crossover, agreement study where 34 patients with SLE from the&#xD;
      Department of Rheumatology at Aalborg University Hospital will be included and randomised in&#xD;
      ratio 1:1 to:&#xD;
&#xD;
        -  Group 1: PROMs are reported through the DANBIO webapp; thereafter, the touchscreen.&#xD;
&#xD;
        -  Group 2: PROMs are reported through the touchscreen; thereafter, the DANBIO webapp.&#xD;
&#xD;
      There will be a wash-out period of 1-2 day between the two registrations to minimise&#xD;
      carryover bias.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">November 25, 2020</completion_date>
  <primary_completion_date type="Actual">November 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>A randomised, within-participants, open, cross-over trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Systemic Lupus Activity Questionnaire global health</measure>
    <time_frame>Day 1 (first data registration) and day 3 (second data registration)</time_frame>
    <description>Evaluates global assessment of lupus activity using an NRS score from 0-10. Higher score Means worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Health Assessment Questionnaire (HAQ)</measure>
    <time_frame>Day 1 (first data registration) and day 3 (second data registration)</time_frame>
    <description>Assess the patient's physical function from 0-3. Higher score Means worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale for Pain</measure>
    <time_frame>Day 1 (first data registration) and day 3 (second data registration)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale for fatigue</measure>
    <time_frame>Day 1 (first data registration) and day 3 (second data registration)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Visual Analogue Scale</measure>
    <time_frame>Day 1 (first data registration) and day 3 (second data registration)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Acceptable Symptom State (PASS)</measure>
    <time_frame>Day 1 (first data registration) and day 3 (second data registration)</time_frame>
    <description>The patient's assessment of acceptable symptom state. Consist of one question answered with &quot;yes&quot; or &quot;no&quot;. 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?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anchoring question</measure>
    <time_frame>Day 1 (first data registration) and day 3 (second data registration)</time_frame>
    <description>The patient's assessment of change in arthritis activity since last visit from much worse to much better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SLAQ flare score</measure>
    <time_frame>Day 1 (first data registration) and day 3 (second data registration)</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SLAQ symptom score</measure>
    <time_frame>Day 1 (first data registration) and day 3 (second data registration)</time_frame>
    <description>Evaluates the number of lupus specific symptoms present from 0-24. Higher score means worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SLAQ total score</measure>
    <time_frame>Day 1 (first data registration) and day 3 (second data registration)</time_frame>
    <description>Evaluates severity of lupus disease activity by a weighted score of the 24 lupus specific symptoms, range 0-44. Higher score means worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>Group WT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>PROM registration via the DANBIO WebApp and thereafter the outpatient touchscreen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group TW</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>PROM registration via the outpatient touchscreen and thereafter the DANBIO WebApp</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order</intervention_name>
    <description>PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order</description>
    <arm_group_label>Group TW</arm_group_label>
    <arm_group_label>Group WT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed in DANBIO with SLE&#xD;
&#xD;
          -  Experience with the PROM questionnaires in DANBIO (≥ 1 previous assessments)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent or to comply with the study protocol&#xD;
&#xD;
          -  Diagnosis of SLE of ≥ 12 months&#xD;
&#xD;
          -  Does not have access to a device that can run the DANBIO webapp&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salome Kristensen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Rheumatology, Aalborg University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Rheumatology</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>March 30, 2021</last_update_submitted>
  <last_update_submitted_qc>March 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University Hospital</investigator_affiliation>
    <investigator_full_name>Salome Kristensen</investigator_full_name>
    <investigator_title>Chief physician, PhD, Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Will be made available when the article is published</ipd_time_frame>
    <ipd_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.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04411407
org study id: 20200527
nct id: NCT04411407
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A randomised, within-participants, open, cross-over trial
primary purpose: Other
masking: None (Open Label)
measure: Change in Systemic Lupus Activity Questionnaire global health
time frame: Day 1 (first data registration) and day 3 (second data registration)
description: Evaluates global assessment of lupus activity using an NRS score from 0-10. Higher score Means worse outcome.
measure: Change in Health Assessment Questionnaire (HAQ)
time frame: Day 1 (first data registration) and day 3 (second data registration)
description: Assess the patient's physical function from 0-3. Higher score Means worse outcome.
measure: Visual Analogue Scale for Pain
time frame: Day 1 (first data registration) and day 3 (second data registration)
description: 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.
measure: Visual Analogue Scale for fatigue
time frame: Day 1 (first data registration) and day 3 (second data registration)
description: 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.
measure: Patient Global Visual Analogue Scale
time frame: Day 1 (first data registration) and day 3 (second data registration)
description: 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.
measure: Patient Acceptable Symptom State (PASS)
time frame: Day 1 (first data registration) and day 3 (second data registration)
description: 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?"
measure: Anchoring question
time frame: Day 1 (first data registration) and day 3 (second data registration)
description: The patient's assessment of change in arthritis activity since last visit from much worse to much better.
measure: SLAQ flare score
time frame: Day 1 (first data registration) and day 3 (second data registration)
description: 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).
measure: SLAQ symptom score
time frame: Day 1 (first data registration) and day 3 (second data registration)
description: Evaluates the number of lupus specific symptoms present from 0-24. Higher score means worse outcome.
measure: SLAQ total score
time frame: Day 1 (first data registration) and day 3 (second data registration)
description: Evaluates severity of lupus disease activity by a weighted score of the 24 lupus specific symptoms, range 0-44. Higher score means worse outcome.
arm group label: Group WT
arm group type: Other
description: PROM registration via the DANBIO WebApp and thereafter the outpatient touchscreen
arm group label: Group TW
arm group type: Other
description: PROM registration via the outpatient touchscreen and thereafter the DANBIO WebApp
intervention type: Device
intervention name: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
description: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
arm group label: Group TW
arm group label: Group WT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 110 Years
healthy volunteers: No
last name: Salome Kristensen, MD, PhD
role: Principal Investigator
affiliation: Department of Rheumatology, Aalborg University Hospital
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Aalborg University Hospital
investigator full name: Salome Kristensen
investigator title: Chief physician, PhD, Principal Investigator
mesh term: Lupus Erythematosus, Systemic
sharing ipd: Yes
ipd description: 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Will be made available when the article is published
ipd 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.