<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/NCT04476875</url>
  </required_header>
  <id_info>
    <org_study_id>Protokol-38787-v1-08072013</org_study_id>
    <nct_id>NCT04476875</nct_id>
  </id_info>
  <brief_title>Outpatient Follow-up on Demand in Rheumatoid Arthritis</brief_title>
  <official_title>Patient-controlled Outpatient Follow-up on Demand for Patients With Rheumatoid Arthritis: a Two-year Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Gentofte, Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</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 two-year randomized controlled trial with rheumatoid arthritis (RA) patients. Patients were&#xD;
      randomized electronically with stratification according to biologic and non-biologic&#xD;
      treatment to the open outpatient clinic programme, or usual care. Patients were evaluated at&#xD;
      baseline, year 1 and 2, including assessment of disease activity and reporting of outcomes&#xD;
      measures on a touch screen at the clinic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. At baseline,&#xD;
      patients were randomized electronically with stratification according to biologic and&#xD;
      non-biologic treatment to the open outpatient clinic programme, or usual care. Patients were&#xD;
      evaluated at baseline, year 1 and 2, including assessment of disease activity (DAS-28), blood&#xD;
      tests, bone erosions on plain radiographs of hands and feet, and patient reported outcome&#xD;
      measures.&#xD;
&#xD;
      The objective of the study was to compare an outpatient system for Danish RA patients based&#xD;
      on patient self-controlled outpatient follow up on demand, Open Outpatient Clinic Programme&#xD;
      with traditional scheduled routine follow-up regarding patient satisfaction and effect on&#xD;
      traditional disease markers.&#xD;
&#xD;
      The Danish National Patient Registry (DANBIO) was used to identify eligible patients with RA.&#xD;
      At pre-planned routine visits with the rheumatologist, identified patients were screened&#xD;
      according to inclusion and exclusion criteria.&#xD;
&#xD;
      The intervention group had no scheduled appointments at the outpatient clinic, but they could&#xD;
      book acute appointments with their contact rheumatologist within 5 days or less whenever they&#xD;
      deemed it necessary. They also had access to nurse-led consultations without pre-booked&#xD;
      appointments and to a nurse-led telephone helpline&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2015</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Observation of clinical outcomes in two groups</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analogue Scale (VAS) Patient satisfaction</measure>
    <time_frame>2 years</time_frame>
    <description>Patient reported outcome which assess overall how satisfied the patient is regarding the management of their rheumatoid arthritis in the hospital setting. Patient satisfaction is scored on a visual analogue scale (VAS). Minimum score is 0 (worst), and maximum score 100 (best).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease activity score in 28 joints (DAS28)</measure>
    <time_frame>2 years</time_frame>
    <description>DAS28 is a measure of disease activity in rheumatoid arthritis. To calculate the DAS28 we counted the number of swollen joints and tender joints (out of the 28), measured C reactive protein (CRP) and assessed the patients 'global assessment of health' (indicated on a visual analogue scale from 0 (best) to 100 (worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic progression</measure>
    <time_frame>2 year</time_frame>
    <description>Radiographs of hands and feet were compared between baseline and follow-up, regarding development of structural changes, including bone erosions. A musculoskeletal radiologist evaluated whether erosive development or progression was present.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">282</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Open outpatient clinic programme (OOCP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>OOCP patients had no scheduled appointments but were allowed acute appointments with their rheumatologist, and had access to nurse-led consultations and telephone helpline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional scheduled routine follow up (TSRF)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Appointments for the TSRF group were scheduled according to routine procedures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Open Outpatient Clinic Programme</intervention_name>
    <arm_group_label>Open outpatient clinic programme (OOCP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        RA. Disease duration of at least 1 year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients treated with monthly intravenous biological medicine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annette Hansen</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Gentofte</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Gentofte</name>
      <address>
        <city>Hellerup</city>
        <state>Copenhagen</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>René Panduro Poggenborg</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Follow-up on demand</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04476875
org study id: Protokol-38787-v1-08072013
nct id: NCT04476875
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. Patients were
      randomized electronically with stratification according to biologic and non-biologic
      treatment to the open outpatient clinic programme, or usual care. Patients were evaluated at
      baseline, year 1 and 2, including assessment of disease activity and reporting of outcomes
      measures on a touch screen at the clinic.
A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. At baseline,
      patients were randomized electronically with stratification according to biologic and
      non-biologic treatment to the open outpatient clinic programme, or usual care. Patients were
      evaluated at baseline, year 1 and 2, including assessment of disease activity (DAS-28), blood
      tests, bone erosions on plain radiographs of hands and feet, and patient reported outcome
      measures.

      The objective of the study was to compare an outpatient system for Danish RA patients based
      on patient self-controlled outpatient follow up on demand, Open Outpatient Clinic Programme
      with traditional scheduled routine follow-up regarding patient satisfaction and effect on
      traditional disease markers.

      The Danish National Patient Registry (DANBIO) was used to identify eligible patients with RA.
      At pre-planned routine visits with the rheumatologist, identified patients were screened
      according to inclusion and exclusion criteria.

      The intervention group had no scheduled appointments at the outpatient clinic, but they could
      book acute appointments with their contact rheumatologist within 5 days or less whenever they
      deemed it necessary. They also had access to nurse-led consultations without pre-booked
      appointments and to a nurse-led telephone helpline
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Observation of clinical outcomes in two groups
primary purpose: Health Services Research
masking: None (Open Label)
measure: Visual analogue Scale (VAS) Patient satisfaction
time frame: 2 years
description: Patient reported outcome which assess overall how satisfied the patient is regarding the management of their rheumatoid arthritis in the hospital setting. Patient satisfaction is scored on a visual analogue scale (VAS). Minimum score is 0 (worst), and maximum score 100 (best).
measure: Disease activity score in 28 joints (DAS28)
time frame: 2 years
description: DAS28 is a measure of disease activity in rheumatoid arthritis. To calculate the DAS28 we counted the number of swollen joints and tender joints (out of the 28), measured C reactive protein (CRP) and assessed the patients 'global assessment of health' (indicated on a visual analogue scale from 0 (best) to 100 (worst)
measure: Radiographic progression
time frame: 2 year
description: Radiographs of hands and feet were compared between baseline and follow-up, regarding development of structural changes, including bone erosions. A musculoskeletal radiologist evaluated whether erosive development or progression was present.
arm group label: Open outpatient clinic programme (OOCP)
arm group type: Active Comparator
description: OOCP patients had no scheduled appointments but were allowed acute appointments with their rheumatologist, and had access to nurse-led consultations and telephone helpline.
arm group label: Traditional scheduled routine follow up (TSRF)
arm group type: No Intervention
description: Appointments for the TSRF group were scheduled according to routine procedures.
intervention type: Other
intervention name: Open Outpatient Clinic Programme
arm group label: Open outpatient clinic programme (OOCP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Annette Hansen
role: Study Chair
affiliation: University Hospital Gentofte
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: René Panduro Poggenborg
investigator title: Principal Investigator
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No