<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/NCT04461080</url>
  </required_header>
  <id_info>
    <org_study_id>UpstreamLab2020-1</org_study_id>
    <nct_id>NCT04461080</nct_id>
  </id_info>
  <brief_title>Screening for Poverty And Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK)</brief_title>
  <acronym>SPARK</acronym>
  <official_title>Screening for Poverty And Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK): a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Memorial University of Newfoundland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Unity Health Toronto</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 SPARK RCT will test the impact of engagement with a Community Health Worker who is&#xD;
      embedded in interprofessional primary care teams on change in estimated annual income at 6&#xD;
      months for people living in poverty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Population: Patients seen by interprofessional primary care teams who are living on estimated&#xD;
      annual incomes that are below the Canadian Low-Income Cut-Off (LICO)&#xD;
&#xD;
      Intervention: A Community Health Worker who implements an intervention that addresses a&#xD;
      number of social needs, including improving income security, access to prescription&#xD;
      medications, access to housing, reducing social isolation, paying for utilities and access to&#xD;
      transportation&#xD;
&#xD;
      Control: Information on community resources on social needs&#xD;
&#xD;
      Outcome: Change in estimated annual income between baseline and at 6 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2022</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2022</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>parallel, two-arm 1:1 individual participant allocation randomized controlled trial</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in estimated annual income</measure>
    <time_frame>6 months</time_frame>
    <description>The primary outcome will be change in estimated annual income, assessed at baseline and at 6 months.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Poverty</condition>
  <arm_group>
    <arm_group_label>Integrated care promoter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who are randomized to the intervention group will be connected with a trained Integrated Care Promoter. The ICP could have a background as a social worker, health promoter or community worker. All ICPs will receive 1 week training to assist participants with social needs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information on community resources</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the control group will receive a list of tailored written information.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community Health Worker</intervention_name>
    <description>Trained Community Health Worker</description>
    <arm_group_label>Information on community resources</arm_group_label>
    <arm_group_label>Integrated care promoter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18+ years old AND live in a household with an income below the Low-Income Cut-OFF AND&#xD;
             agree to receive assistance with social needs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has worked with a similar CHW or intervention in the past 1 year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>We will ask participants both their sex assigned at birth and their current gender identity, and offer a number of options.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew D Pinto, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rose Wang, MPH</last_name>
    <phone>416-864-6060</phone>
    <phone_ext>76223</phone_ext>
    <email>rose.wang@unityhealth.to</email>
  </overall_contact>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>poverty</keyword>
  <keyword>income</keyword>
  <keyword>social determinants of health</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>As the study progresses, we will explore sharing IPD with other researchers upon request.</ipd_description>
  </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/NCT04461080
org study id: UpstreamLab2020-1
nct id: NCT04461080
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The SPARK RCT will test the impact of engagement with a Community Health Worker who is
      embedded in interprofessional primary care teams on change in estimated annual income at 6
      months for people living in poverty.
Population: Patients seen by interprofessional primary care teams who are living on estimated
      annual incomes that are below the Canadian Low-Income Cut-Off (LICO)

      Intervention: A Community Health Worker who implements an intervention that addresses a
      number of social needs, including improving income security, access to prescription
      medications, access to housing, reducing social isolation, paying for utilities and access to
      transportation

      Control: Information on community resources on social needs

      Outcome: Change in estimated annual income between baseline and at 6 months
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: parallel, two-arm 1:1 individual participant allocation randomized controlled trial
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: change in estimated annual income
time frame: 6 months
description: The primary outcome will be change in estimated annual income, assessed at baseline and at 6 months.
arm group label: Integrated care promoter
arm group type: Experimental
description: Patients who are randomized to the intervention group will be connected with a trained Integrated Care Promoter. The ICP could have a background as a social worker, health promoter or community worker. All ICPs will receive 1 week training to assist participants with social needs.
arm group label: Information on community resources
arm group type: Active Comparator
description: Patients randomized to the control group will receive a list of tailored written information.
intervention type: Behavioral
intervention name: Community Health Worker
description: Trained Community Health Worker
arm group label: Information on community resources
arm group label: Integrated care promoter
criteria: 
gender: All
gender based: Yes
gender description: We will ask participants both their sex assigned at birth and their current gender identity, and offer a number of options.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew D Pinto, MD MSc
role: Principal Investigator
affiliation: University of Toronto
last name: Rose Wang, MPH
phone: 416-864-6060
phone ext: 76223
email: rose.wang@unityhealth.to
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: As the study progresses, we will explore sharing IPD with other researchers upon request.