<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/NCT03773471</url>
  </required_header>
  <id_info>
    <org_study_id>17-005947</org_study_id>
    <nct_id>NCT03773471</nct_id>
  </id_info>
  <brief_title>A Multi-Center Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making</brief_title>
  <official_title>A Multi-Center Cluster Randomized Controlled Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      The overall goal is to improve shared decision-making (SDM) about treatment options and&#xD;
      thereby enhance disease outcomes and health-related quality of life (HRQOL) for patients with&#xD;
      rheumatoid arthritis (RA). The objective of this study is to engage patients in using the&#xD;
      ArthritisPower application on a weekly basis during the time between clinic appointments for&#xD;
      collection of data on self-reported disease activity and patient-reported outcomes (PROs),&#xD;
      and to display the data using an iPad to the patients and their rheumatology health care&#xD;
      providers (HCPs) at the point of care for SDM.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2020</start_date>
  <completion_date type="Actual">June 21, 2023</completion_date>
  <primary_completion_date type="Actual">June 21, 2023</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>- Determine the impact of ArthritisPower™ integration into the clinical evaluation of patients with RA on the primary endpoint of clinical improvement as defined by the continuous change in the Clinical Disease Activity Index (CDAI) (1).</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mobile Health App</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile Health App</intervention_name>
    <description>ArthritisPower App</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Age ≥ 18 years.&#xD;
&#xD;
          2. Fulfillment of the ACR/EULAR 2010 classification criteria for RA [9].&#xD;
&#xD;
          3. Moderate or high disease activity, according to CDAI ≥ 10, at the baseline visit.&#xD;
&#xD;
          4. Intent to modify DMARD therapy (i.e., adding a DMARD, switching to a new DMARD, or&#xD;
             changing DMARD dosage) by the patient and HCP.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Current or previous use of ArthritisPower™ by the patient.&#xD;
&#xD;
          2. Lack of access to an ArthritisPower™ compatible device (e.g., smartphone, tablet, or&#xD;
             computer)&#xD;
&#xD;
          3. Inability or unwillingness to participate with using the ArthritisPower™ app for this&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John M Davis</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michigan Medicine - Rheumatology</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5358</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>John M. Davis, III</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT03773471
org study id: 17-005947
nct id: NCT03773471
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall goal is to improve shared decision-making (SDM) about treatment options and
      thereby enhance disease outcomes and health-related quality of life (HRQOL) for patients with
      rheumatoid arthritis (RA). The objective of this study is to engage patients in using the
      ArthritisPower application on a weekly basis during the time between clinic appointments for
      collection of data on self-reported disease activity and patient-reported outcomes (PROs),
      and to display the data using an iPad to the patients and their rheumatology health care
      providers (HCPs) at the point of care for SDM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: - Determine the impact of ArthritisPower™ integration into the clinical evaluation of patients with RA on the primary endpoint of clinical improvement as defined by the continuous change in the Clinical Disease Activity Index (CDAI) (1).
time frame: 24 months
arm group label: Control Arm
arm group type: No Intervention
description: Standard of care
arm group label: Intervention Arm
arm group type: Experimental
description: Mobile Health App
intervention type: Behavioral
intervention name: Mobile Health App
description: ArthritisPower App
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John M Davis
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: John M. Davis, III
investigator title: Principal Investigator
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid