<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/NCT03263169</url>
  </required_header>
  <id_info>
    <org_study_id>HealthTap-WEPilot</org_study_id>
    <nct_id>NCT03263169</nct_id>
  </id_info>
  <brief_title>Community-based Personalized Care and QOL</brief_title>
  <official_title>A Pragmatic Trial to Evaluate the Impact of Community-based Personalized Care on Quality of Life in Older and Disabled Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Windsor-Essex Compassionate Care Community</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Windsor</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Western Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Green Shield Canada Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erie St. Clair Local Health Integration Network (LHIN)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Windsor-Essex Compassionate Care Community</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 pragmatic randomized trial to evaluate the impact of an integrated patient experience and&#xD;
      outcome measurement system supported by citizens, caregivers and community through eHealth&#xD;
      technology.&#xD;
&#xD;
      The primary research question is: What is the effectiveness of the WECCC approach on quality&#xD;
      of life in people aged 65 and older or who self-identify as disabled compared to people not&#xD;
      receiving the Health TAPESTRY program?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Secondary research questions include:&#xD;
&#xD;
        1. what is the feasibility of obtaining study measures through routinely collected program&#xD;
           participant data and what design adjustments are needed to balance pragmatism and high&#xD;
           quality data collection?&#xD;
&#xD;
        2. What are the analytic approaches to be developed to aggregate data from individual&#xD;
           participants into meaningful units (e.g. care-team level, organizational level, social&#xD;
           network, and geographic area) to inform ongoing adaptation of the components of the&#xD;
           intervention?&#xD;
&#xD;
        3. what are the perceptions of knowledge users on the usefulness of comparative&#xD;
           effectiveness pragmatic trial evidence?&#xD;
&#xD;
      The project involves using administrative data from the ICES to create outcome measures and&#xD;
      feedback systems for communities, and the INSPIRE PHC Unit for expertise in health system&#xD;
      integration, care in the community, and knowledge translation.&#xD;
&#xD;
      Inclusion criteria: Seniors (65+) and people who self-identify as having a functional&#xD;
      disability. Pilot study sites: 7 municipalities and the city of Windsor in Windsor-Essex&#xD;
      County in Ontario. The combined total eligible population in all 8 sites is about 60,000&#xD;
      people, from which a minimum sample of 3000 registered patients and 1000 registered&#xD;
      caregivers will be drawn&#xD;
&#xD;
      In Year 1, planned enrolment includes a minimum of 1100 intervention clients from all&#xD;
      recruitment methods in the care model intervention, with similar numbers of control and&#xD;
      intention to treat clients.&#xD;
&#xD;
      The primary outcomes are quality of life (QOL); perceived health; experience of care, and&#xD;
      perceived social connection.&#xD;
&#xD;
      The primary outcomes for caregivers will be quality of life; perceived burden; caregiver&#xD;
      perceptions of care; and perceived social connection.&#xD;
&#xD;
      Secondary outcomes for both will include goal attainment, distress management, symptom&#xD;
      management, places of care, and health care utilization and costs. In terms of health equity,&#xD;
      the investigators will measure the difference between the average/median population quality&#xD;
      of life and cost outcomes compared to patients at the bottom income quartiles stratified by&#xD;
      risk level. At a systems level, algorithms will be developed and applied to the data&#xD;
      collected from participants to provide aggregate organization and system-level reports,&#xD;
      co-designed with end users to support them as learning organizations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2018</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>2 Years</target_duration>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Baseline and then monthly for 24 months</time_frame>
    <description>McGill QoL - patient and family</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived health</measure>
    <time_frame>Baseline and then monthly for 24 months</time_frame>
    <description>EQ-5D-5L - patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caregiver Burden 1</measure>
    <time_frame>Baseline and then monthly for 24 months</time_frame>
    <description>InterRAI-home care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Burden 2</measure>
    <time_frame>Baseline and then monthly for 24 months</time_frame>
    <description>Zarit burden interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient experience</measure>
    <time_frame>Baseline and then monthly for 24 months</time_frame>
    <description>CANHelp Patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family experience</measure>
    <time_frame>Baseline and then monthly for 24 months</time_frame>
    <description>CANHelp Family</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom management 1</measure>
    <time_frame>Baseline and then monthly for 24 months</time_frame>
    <description>Edmonton Symptom Assessment Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom management 2</measure>
    <time_frame>Baseline and then monthly for 24 months</time_frame>
    <description>Palliative Performance Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom management 3</measure>
    <time_frame>Baseline and then monthly for 24 months</time_frame>
    <description>InterRAI-home care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health services utilization 1</measure>
    <time_frame>Baseline and then monthly for 24 months</time_frame>
    <description>hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health services utilization 2</measure>
    <time_frame>Baseline and then monthly for 24 months</time_frame>
    <description>Emergency care</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1100</enrollment>
  <condition>Aging</condition>
  <condition>Disability or Chronic Disease Leading to Disablement</condition>
  <arm_group>
    <arm_group_label>WE Health Tapestry</arm_group_label>
    <description>Completion of baseline measures then enrolled in a community-based personalized care intervention that consists of four core elements: volunteer support, interprofessional care, technology, social network linkage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <description>Completion of baseline measures with six-month delayed community-based personalized care intervention: volunteer support, interprofessional care, technology, social network linkage</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community-based personalized care</intervention_name>
    <description>volunteer support, health technology, interprofessional care, social network linkage</description>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_label>WE Health Tapestry</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Seniors who identify with having a functional disability or serious chronic disease; and&#xD;
        informal caregivers. Many patients within this broad target population will be at risk of&#xD;
        worsening quality of life or escalating health care utilization now or in the future due to&#xD;
        aging, disease progression, or unmet health, social or economic needs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Individuals who:&#xD;
&#xD;
          1. are 65 years of age and over&#xD;
&#xD;
          2. have a long-term disability or one or more chronic diseases&#xD;
&#xD;
          3. able to communicate in English OR can provide a formal or informal translator willing&#xD;
             to facilitate the participant's involvement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Individuals not meeting above criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle Howard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Dolovich, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kathryn Pfaff, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Windsor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Deborah Sattler</last_name>
    <phone>974-2581</phone>
    <phone_ext>2420</phone_ext>
    <email>deborah@deborahsattler.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kathryn A Pfaff, PhD</last_name>
    <phone>253-3000</phone>
    <phone_ext>4977</phone_ext>
    <email>kpfaff@uwindsor.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Windsor-Essex Compassionate Care Community Program Management Office</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8T 1B5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Deborah Sattler</last_name>
      <phone>519-974-2581</phone>
      <phone_ext>2420</phone_ext>
      <email>deborah@deborahsattler.ca</email>
    </contact>
    <contact_backup>
      <last_name>Diane Halbgewachs</last_name>
      <phone>519-974-2581</phone>
      <phone_ext>2420</phone_ext>
      <email>DHalbgewachs2@thehospice.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Michelle Howard, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lisa Dolovich, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kathryn Pfaff, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Merrick Zwarenstein, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>e-health, community networks, pragmatic RCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03263169
org study id: HealthTap-WEPilot
nct id: NCT03263169
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A pragmatic randomized trial to evaluate the impact of an integrated patient experience and
      outcome measurement system supported by citizens, caregivers and community through eHealth
      technology.

      The primary research question is: What is the effectiveness of the WECCC approach on quality
      of life in people aged 65 and older or who self-identify as disabled compared to people not
      receiving the Health TAPESTRY program?
Secondary research questions include:

        1. what is the feasibility of obtaining study measures through routinely collected program
           participant data and what design adjustments are needed to balance pragmatism and high
           quality data collection?

        2. What are the analytic approaches to be developed to aggregate data from individual
           participants into meaningful units (e.g. care-team level, organizational level, social
           network, and geographic area) to inform ongoing adaptation of the components of the
           intervention?

        3. what are the perceptions of knowledge users on the usefulness of comparative
           effectiveness pragmatic trial evidence?

      The project involves using administrative data from the ICES to create outcome measures and
      feedback systems for communities, and the INSPIRE PHC Unit for expertise in health system
      integration, care in the community, and knowledge translation.

      Inclusion criteria: Seniors (65+) and people who self-identify as having a functional
      disability. Pilot study sites: 7 municipalities and the city of Windsor in Windsor-Essex
      County in Ontario. The combined total eligible population in all 8 sites is about 60,000
      people, from which a minimum sample of 3000 registered patients and 1000 registered
      caregivers will be drawn

      In Year 1, planned enrolment includes a minimum of 1100 intervention clients from all
      recruitment methods in the care model intervention, with similar numbers of control and
      intention to treat clients.

      The primary outcomes are quality of life (QOL); perceived health; experience of care, and
      perceived social connection.

      The primary outcomes for caregivers will be quality of life; perceived burden; caregiver
      perceptions of care; and perceived social connection.

      Secondary outcomes for both will include goal attainment, distress management, symptom
      management, places of care, and health care utilization and costs. In terms of health equity,
      the investigators will measure the difference between the average/median population quality
      of life and cost outcomes compared to patients at the bottom income quartiles stratified by
      risk level. At a systems level, algorithms will be developed and applied to the data
      collected from participants to provide aggregate organization and system-level reports,
      co-designed with end users to support them as learning organizations.
observational model: Cohort
time perspective: Prospective
measure: Quality of Life
time frame: Baseline and then monthly for 24 months
description: McGill QoL - patient and family
measure: Perceived health
time frame: Baseline and then monthly for 24 months
description: EQ-5D-5L - patient
measure: Caregiver Burden 1
time frame: Baseline and then monthly for 24 months
description: InterRAI-home care
measure: Caregiver Burden 2
time frame: Baseline and then monthly for 24 months
description: Zarit burden interview
measure: Patient experience
time frame: Baseline and then monthly for 24 months
description: CANHelp Patient
measure: Family experience
time frame: Baseline and then monthly for 24 months
description: CANHelp Family
measure: Symptom management 1
time frame: Baseline and then monthly for 24 months
description: Edmonton Symptom Assessment Scale
measure: Symptom management 2
time frame: Baseline and then monthly for 24 months
description: Palliative Performance Scale
measure: Symptom management 3
time frame: Baseline and then monthly for 24 months
description: InterRAI-home care
measure: Health services utilization 1
time frame: Baseline and then monthly for 24 months
description: hospitalization
measure: Health services utilization 2
time frame: Baseline and then monthly for 24 months
description: Emergency care
arm group label: WE Health Tapestry
description: Completion of baseline measures then enrolled in a community-based personalized care intervention that consists of four core elements: volunteer support, interprofessional care, technology, social network linkage
arm group label: Usual Care
description: Completion of baseline measures with six-month delayed community-based personalized care intervention: volunteer support, interprofessional care, technology, social network linkage
intervention type: Behavioral
intervention name: Community-based personalized care
description: volunteer support, health technology, interprofessional care, social network linkage
arm group label: Usual Care
arm group label: WE Health Tapestry
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michelle Howard, PhD
role: Principal Investigator
affiliation: McMaster University
last name: Lisa Dolovich, PhD
role: Principal Investigator
affiliation: McMaster University
last name: Kathryn Pfaff, PhD
role: Principal Investigator
affiliation: University of Windsor
last name: Deborah Sattler
phone: 974-2581
phone ext: 2420
email: deborah@deborahsattler.ca
last name: Kathryn A Pfaff, PhD
phone: 253-3000
phone ext: 4977
email: kpfaff@uwindsor.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Chronic Disease
sharing ipd: Undecided