<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/NCT03840928</url>
  </required_header>
  <id_info>
    <org_study_id>GlobalHealthyLivingF</org_study_id>
    <nct_id>NCT03840928</nct_id>
  </id_info>
  <brief_title>AR-Power Patient Powered Research Network</brief_title>
  <acronym>GHLF</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Global Healthy Living Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Global Healthy Living Foundation</source>
  <brief_summary>
    <textblock>
      ArthritisPower is a patient research network and database (registry) to collect prospective&#xD;
      information about demographics, self-reported diagnoses and medications, and willingness to&#xD;
      participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis&#xD;
      (SpA), and other musculoskeletal conditions. Participants will provide information from their&#xD;
      smartphones or personal computers. The information will be used by researchers to help&#xD;
      patients and their providers make better, more informed decisions about treatment of RA/SpA&#xD;
      and other musculoskeletal conditions. ArthritisPower is part of a larger national research&#xD;
      network called PCORnet whose 33 network members have mapped their data to a common data&#xD;
      model. Network members will be able to submit queries through PCORnet in order to answer a&#xD;
      range of comparative effectiveness research questions. Data sharing across PCORnet will be&#xD;
      accomplished using secure methods to prevent patient identification. There is no cost to&#xD;
      participants for participating and no compensation is provided.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. To establish a research registry to enable comparative effectiveness research in&#xD;
           rheumatic diseases and other musculoskeletal conditions. All data collected using the&#xD;
           ArthritisPower mobile app as part of a subject's use is stored with the ArthritisPower&#xD;
           registry. This data will be used in conjunction with existing and future research&#xD;
           studies.&#xD;
&#xD;
        2. To use the data from this study to improve treatment and to further advance finding a&#xD;
           cure for rheumatic diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2015</start_date>
  <completion_date type="Anticipated">March 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Pain Interference (PROMIS)</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue (PROMIS)</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Disturbance (PROMIS)</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Function (PROMIS)</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>RAPID-3 (MD-HAQ with visual analogue scale for pain and patient global measure for overall health)</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <number_of_groups>13</number_of_groups>
  <enrollment type="Anticipated">9867</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Ankylosing Spondylitis</condition>
  <condition>Fibromyalgia</condition>
  <condition>Gout</condition>
  <condition>Crohn Disease</condition>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <condition>Lupus Erythematosus</condition>
  <condition>Myositis</condition>
  <condition>Osteoarthritis</condition>
  <condition>Osteoporosis</condition>
  <condition>Psoriasis</condition>
  <condition>Psoriatic Arthritis</condition>
  <condition>Scleroderma</condition>
  <arm_group>
    <arm_group_label>Ankylosing Spondylitis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Fibromyalgia</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Gout</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Crohn's-related Arthritis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Juvenile Idiopathic Arthritis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Lupus</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Myositis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Osteoarthritis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Osteoporosis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Psoriasis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Psoriatic Arthritis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Rheumatoid Arthritis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Scleroderma</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be derived from the population of people who indicate that they have been&#xD;
        diagnosed by a physician as having musculoskeletal conditions including RA, SpA and other&#xD;
        chronic musculoskeletal conditions. These will come from two sources:&#xD;
&#xD;
          1. CreakyJoints website, an online rheumatic-disease patient support community&#xD;
             (www.CreakyJoints.org), composed of patients with arthritis and arthritis-related&#xD;
             disease, CreakyJoints members with self-reported musculoskeletal conditions will be&#xD;
             invited to join the ArthritisPower research registry and download the ArthritisPower&#xD;
             App.&#xD;
&#xD;
          2. CreakyJoints Facebook and Twitter social network platforms. CreakyJoints &quot;fans&quot; or&#xD;
             &quot;followers&quot; will be told about the ArthritisPower registry and app on the CreakyJoints&#xD;
             Facebook page (www.Facebook.com/CreakyJoints) and/or Twitter account&#xD;
             (https://twitter.com/creakyjoints).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 19 and above. We will only allow Puerto Rican residents to join if they are 21 or&#xD;
             older. We will add conditional logic in the registration to ensure that Puerto Ricans&#xD;
             under the age of 21 cannot complete the registration and participate in&#xD;
             ArthritisPower.&#xD;
&#xD;
          2. Self-report that a physician has given a diagnosis of RA, SpA, or other&#xD;
             musculoskeletal condition.&#xD;
&#xD;
          3. The Registry is only intended at this time for residents of the United States and&#xD;
             United States territories who are nineteen (19) years or older (for Puerto Rico&#xD;
             residents, you must be 21 years or older to participate).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        a) Age &lt; 19 years b) No self-reported physician diagnosis of musculoskeletal condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ben Nowell, PhD</last_name>
    <phone>(845) 348 0400</phone>
    <phone_ext>105</phone_ext>
    <email>bnowell@ghlf.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laura Stradford, MPH</last_name>
    <phone>(845) 348 0400</phone>
    <phone_ext>210</phone_ext>
    <email>lstradford@ghlf.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Global Healthy Living Foundation</name>
      <address>
        <city>Upper Nyack</city>
        <state>New York</state>
        <zip>10960</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>December 23, 2022</last_update_submitted>
  <last_update_submitted_qc>December 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Global Healthy Living Foundation</investigator_affiliation>
    <investigator_full_name>Ben Nowell</investigator_full_name>
    <investigator_title>Director, Patient-Centered Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
    <mesh_term>Myositis</mesh_term>
    <mesh_term>Crohn Disease</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/NCT03840928
org study id: GlobalHealthyLivingF
nct id: NCT03840928
lead sponsor: 
collaborator: 
ArthritisPower is a patient research network and database (registry) to collect prospective
      information about demographics, self-reported diagnoses and medications, and willingness to
      participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis
      (SpA), and other musculoskeletal conditions. Participants will provide information from their
      smartphones or personal computers. The information will be used by researchers to help
      patients and their providers make better, more informed decisions about treatment of RA/SpA
      and other musculoskeletal conditions. ArthritisPower is part of a larger national research
      network called PCORnet whose 33 network members have mapped their data to a common data
      model. Network members will be able to submit queries through PCORnet in order to answer a
      range of comparative effectiveness research questions. Data sharing across PCORnet will be
      accomplished using secure methods to prevent patient identification. There is no cost to
      participants for participating and no compensation is provided.

      Objectives:

        1. To establish a research registry to enable comparative effectiveness research in
           rheumatic diseases and other musculoskeletal conditions. All data collected using the
           ArthritisPower mobile app as part of a subject's use is stored with the ArthritisPower
           registry. This data will be used in conjunction with existing and future research
           studies.

        2. To use the data from this study to improve treatment and to further advance finding a
           cure for rheumatic diseases.
observational model: Cohort
time perspective: Prospective
measure: Pain Interference (PROMIS)
time frame: 7 days
measure: Fatigue (PROMIS)
time frame: 7 days
measure: Sleep Disturbance (PROMIS)
time frame: 7 days
measure: Physical Function (PROMIS)
time frame: 7 days
measure: RAPID-3 (MD-HAQ with visual analogue scale for pain and patient global measure for overall health)
time frame: 7 days
arm group label: Ankylosing Spondylitis
arm group label: Fibromyalgia
arm group label: Gout
arm group label: Crohn's-related Arthritis
arm group label: Juvenile Idiopathic Arthritis
arm group label: Lupus
arm group label: Myositis
arm group label: Osteoarthritis
arm group label: Osteoporosis
arm group label: Psoriasis
arm group label: Psoriatic Arthritis
arm group label: Rheumatoid Arthritis
arm group label: Scleroderma
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ben Nowell, PhD
phone: (845) 348 0400
phone ext: 105
email: bnowell@ghlf.org
last name: Laura Stradford, MPH
phone: (845) 348 0400
phone ext: 210
email: lstradford@ghlf.org
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: Global Healthy Living Foundation
investigator full name: Ben Nowell
investigator title: Director, Patient-Centered Research
mesh term: Spondylitis
mesh term: Arthritis
mesh term: Osteoporosis
mesh term: Fibromyalgia
mesh term: Arthritis, Psoriatic
mesh term: Spondylitis, Ankylosing
mesh term: Arthritis, Juvenile
mesh term: Myositis
mesh term: Crohn Disease