xml: <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/NCT06000696</url>
    </required_header>
    <id_info>
      <org_study_id>20224690</org_study_id>
      <nct_id>NCT06000696</nct_id>
    </id_info>
    <brief_title>Healthy at Home Pilot</brief_title>
    <official_title>Healthy at Home: Feasibility Trial of Home-Based Management of Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Digital Technology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Massachusetts, Worcester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>UMass Memorial Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Massachusetts, Worcester</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective is to conduct a pilot-feasibility trial of the &quot;Healthy at Home&quot; program, a&#xD;
        multimodal intervention aimed at preventing acute care needs among COPD patients. The program&#xD;
        will feature a digital platform and virtual pulmonary rehabilitation to facilitate complex&#xD;
        care management of UMass Memorial Health Patients&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Healthy at Home project is a pilot program aimed at improving care for patients who have&#xD;
        COPD. This pilot aims to establish how self-management using a digital application, mobile&#xD;
        health services, and support from a wellness coach can help achieve this goal. Participation&#xD;
        in this study involves participants downloading a smartphone app, answering questionnaires,&#xD;
        and wearing a Fitbit everyday, including during sleep throughout the 6-month study period.&#xD;
        The investigators will ask that participants share their medical records and healthcare visit&#xD;
        information through the secure study app, to help better understand how to treat patients&#xD;
        with chronic health conditions. Participants will additionally have the option to enroll in&#xD;
        Wellinks, a program that helps patients manage their breathing and COPD symptoms and provides&#xD;
        patients with at-home medical equipment, one-on-one personalized virtual support from&#xD;
        specially trained clinicians and coaches, and a separate easy-to-use app for tracking and&#xD;
        communication.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">September 9, 2022</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>6 Months</target_duration>
    <primary_outcome>
      <measure>Enroll</measure>
      <time_frame>14 months</time_frame>
      <description>Develop and use a smartphone app to enroll 100 UMass Memorial Health patients into the Healthy at Home program based on their short-term risk of requiring acute care needs.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Enhance</measure>
      <time_frame>18 months</time_frame>
      <description>Enhance the existing Mobile Integrated Health (MIH) dashboard that currently only tracks care episodes by remotely collecting biometric data (oxygen saturation, respiratory rate, body temperature, heart rate) and participant reported data to allow the MIH paramedics to review longitudinal history of the patients prior to and after providing care.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluate</measure>
      <time_frame>24 months</time_frame>
      <description>Follow enrolled participants for six months to measure feasibility (adherence, usability) and clinical (patient-reported outcomes, healthcare utilization, total medical expenditure) outcomes at baseline, 3-months, and 6-months. Compare outcomes across full-intervention (Healthy at Home w/ virtual pulmonary therapy group), partial-intervention (Healthy at Home), and control (synthetic controls derived from EMR) after adjusting for baseline risk of acute-care needs.</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>COPD</condition>
    <condition>COPD Exacerbation</condition>
    <condition>Emphysema or COPD</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients of Umass Memorial Health system who have a diagnosis of COPD and live within the&#xD;
          geographic area served by the Mobile Integrated Health program who are identified as&#xD;
          potentially being a fit for the study program and are willing and able to download the&#xD;
          study app and consent to the study via the app.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Receives healthcare through UMass Memorial Health&#xD;
  &#xD;
            -  Is at least 18 years old&#xD;
  &#xD;
            -  Has a self-reported or EMR observed diagnosis of COPD&#xD;
  &#xD;
            -  Has access to a smartphone (iPhone or Android) to download and use the study app(s)&#xD;
  &#xD;
            -  Lives within the geographic area served by the Mobile Integrated Health program&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lacks capacity to consent&#xD;
  &#xD;
            -  Does not understand English&#xD;
  &#xD;
            -  Does not have internet access on their smartphone at home&#xD;
  &#xD;
            -  Are currently enrolled in another investigational clinical trial&#xD;
  &#xD;
            -  Are or have previously been enrolled in any Wellinks program&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Apurv Soni, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Massachusetts Chan Medical School</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>UMass Chan Medical School</name>
        <address>
          <city>Worcester</city>
          <state>Massachusetts</state>
          <zip>01655</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
      <investigator_full_name>Apurv Soni</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emphysema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000696
  org study id: 20224690
  nct id: NCT06000696
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective is to conduct a pilot-feasibility trial of the "Healthy at Home" program, a
        multimodal intervention aimed at preventing acute care needs among COPD patients. The program
        will feature a digital platform and virtual pulmonary rehabilitation to facilitate complex
        care management of UMass Memorial Health Patients
  The Healthy at Home project is a pilot program aimed at improving care for patients who have
        COPD. This pilot aims to establish how self-management using a digital application, mobile
        health services, and support from a wellness coach can help achieve this goal. Participation
        in this study involves participants downloading a smartphone app, answering questionnaires,
        and wearing a Fitbit everyday, including during sleep throughout the 6-month study period.
        The investigators will ask that participants share their medical records and healthcare visit
        information through the secure study app, to help better understand how to treat patients
        with chronic health conditions. Participants will additionally have the option to enroll in
        Wellinks, a program that helps patients manage their breathing and COPD symptoms and provides
        patients with at-home medical equipment, one-on-one personalized virtual support from
        specially trained clinicians and coaches, and a separate easy-to-use app for tracking and
        communication.
  observational model: Cohort
  time perspective: Prospective
  measure: Enroll
  time frame: 14 months
  description: Develop and use a smartphone app to enroll 100 UMass Memorial Health patients into the Healthy at Home program based on their short-term risk of requiring acute care needs.
  measure: Enhance
  time frame: 18 months
  description: Enhance the existing Mobile Integrated Health (MIH) dashboard that currently only tracks care episodes by remotely collecting biometric data (oxygen saturation, respiratory rate, body temperature, heart rate) and participant reported data to allow the MIH paramedics to review longitudinal history of the patients prior to and after providing care.
  measure: Evaluate
  time frame: 24 months
  description: Follow enrolled participants for six months to measure feasibility (adherence, usability) and clinical (patient-reported outcomes, healthcare utilization, total medical expenditure) outcomes at baseline, 3-months, and 6-months. Compare outcomes across full-intervention (Healthy at Home w/ virtual pulmonary therapy group), partial-intervention (Healthy at Home), and control (synthetic controls derived from EMR) after adjusting for baseline risk of acute-care needs.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Apurv Soni, MD, PhD
  role: Principal Investigator
  affiliation: University of Massachusetts Chan Medical School
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Massachusetts, Worcester
  investigator full name: Apurv Soni
  investigator title: Assistant Professor
  mesh term: Emphysema
  sharing ipd: No