<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/NCT04426305</url>
  </required_header>
  <id_info>
    <org_study_id>BC-07744.</org_study_id>
    <nct_id>NCT04426305</nct_id>
  </id_info>
  <brief_title>Community Health Workers Against COVID19</brief_title>
  <official_title>Community Health Workers Against COVID19 Tackling Psychosocial Suffering Due to Physical Distancing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Randomized controlled trial among patients from family practices at risk of psychosocial&#xD;
      suffering due to social distancing measures. Patients from the intervention group receive&#xD;
      support from community health workers. contacted at least 8 times by community health&#xD;
      workers. Evolution of psychosocial wellbeing is evaluated by questionnaires at time 0 and&#xD;
      after 6 weeks of intervention. Psychosocial outcomes are compared between control and&#xD;
      intervention groups. Process evaluation will be done through in-depth interviews.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients vulnerable for psychosocial suffering due to social distancing measures are&#xD;
      recruited by family practitioners in the City of Ghent. The recruited patients are randomly&#xD;
      selected into a control and intervention group. Based on the validated Promis instruments,&#xD;
      all participants are interviewed face to face on their mental and social health at time 0 and&#xD;
      after 6 weeks of intervention. Patients from the intervention group are contacted by&#xD;
      Community health workers after the first interview. Community health workers offer emotional&#xD;
      support to the patients through at least 8 contacts over 6 weeks. The control group receive&#xD;
      care as usual and are offered support by community health workers after the second interview.&#xD;
      In depth interviews (qualitative study) will be conducted among community health workers and&#xD;
      patients after finalizing the post-intervention questionnaires.&#xD;
&#xD;
      Research questions: What are the psychosocial consequences of social distancing for at-risk&#xD;
      groups? Can community health workers reduce the psychosocial impact of physical distancing&#xD;
      measures isolation?&#xD;
&#xD;
      Relevance: Understanding community-based psychosocial support for vulnerable people during&#xD;
      and after health crises.&#xD;
&#xD;
      Keywords: Community health workers, psychosocial, health crises&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 20, 2020</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>Supportive Care</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument)</measure>
    <time_frame>change from baseline at 6 weeks</time_frame>
    <description>The PROMIS Emotional Support questionnaire assesses perceived feelings of being cared for and valued as a person;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient-reported Social Isolation (based on the PROMIS® Emotional Support instrument)</measure>
    <time_frame>change from baseline at 6 weeks</time_frame>
    <description>The PROMIS Social Isolation questionnaire assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient-reported Ability to participate in social roles and activities (based on the PROMIS® ability to participate in social roles and activities instrument)</measure>
    <time_frame>change from baseline at 6 weeks</time_frame>
    <description>The PROMIS adult Ability to Participate in Social Roles and Activities questionnaire assesses the perceived ability to perform one's usual social roles and activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient-reported anxiety (based on the PROMIS® anxiety instrument)</measure>
    <time_frame>change from baseline at 6 weeks</time_frame>
    <description>The PROMIS Anxiety questionnaire assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Covid 19</condition>
  <condition>Social Isolation</condition>
  <condition>Mental Health Impairment</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>psychosocial support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>care as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>community health worker support</intervention_name>
    <description>usual care by professional primary care providers + emotional support by trained community health worker</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>care as usual</intervention_name>
    <description>care as usual is provided by professional primary care provider</description>
    <arm_group_label>control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients recruited by family practitioners based on anticipated psychosocial impact of&#xD;
             physical distancing measures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe psychiatric diseases (psychosis, severe depression)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Public Health and Primary Care</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 7, 2021</last_update_submitted>
  <last_update_submitted_qc>June 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Community health workers</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>psychosocial impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT04426305
org study id: BC-07744.
nct id: NCT04426305
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Randomized controlled trial among patients from family practices at risk of psychosocial
      suffering due to social distancing measures. Patients from the intervention group receive
      support from community health workers. contacted at least 8 times by community health
      workers. Evolution of psychosocial wellbeing is evaluated by questionnaires at time 0 and
      after 6 weeks of intervention. Psychosocial outcomes are compared between control and
      intervention groups. Process evaluation will be done through in-depth interviews.
Patients vulnerable for psychosocial suffering due to social distancing measures are
      recruited by family practitioners in the City of Ghent. The recruited patients are randomly
      selected into a control and intervention group. Based on the validated Promis instruments,
      all participants are interviewed face to face on their mental and social health at time 0 and
      after 6 weeks of intervention. Patients from the intervention group are contacted by
      Community health workers after the first interview. Community health workers offer emotional
      support to the patients through at least 8 contacts over 6 weeks. The control group receive
      care as usual and are offered support by community health workers after the second interview.
      In depth interviews (qualitative study) will be conducted among community health workers and
      patients after finalizing the post-intervention questionnaires.

      Research questions: What are the psychosocial consequences of social distancing for at-risk
      groups? Can community health workers reduce the psychosocial impact of physical distancing
      measures isolation?

      Relevance: Understanding community-based psychosocial support for vulnerable people during
      and after health crises.

      Keywords: Community health workers, psychosocial, health crises
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Care Provider)
measure: Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument)
time frame: change from baseline at 6 weeks
description: The PROMIS Emotional Support questionnaire assesses perceived feelings of being cared for and valued as a person;
measure: Change in patient-reported Social Isolation (based on the PROMIS® Emotional Support instrument)
time frame: change from baseline at 6 weeks
description: The PROMIS Social Isolation questionnaire assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others.
measure: Change in patient-reported Ability to participate in social roles and activities (based on the PROMIS® ability to participate in social roles and activities instrument)
time frame: change from baseline at 6 weeks
description: The PROMIS adult Ability to Participate in Social Roles and Activities questionnaire assesses the perceived ability to perform one's usual social roles and activities.
measure: Change in patient-reported anxiety (based on the PROMIS® anxiety instrument)
time frame: change from baseline at 6 weeks
description: The PROMIS Anxiety questionnaire assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness).
arm group label: Intervention arm
arm group type: Experimental
description: psychosocial support
arm group label: control arm
arm group type: Active Comparator
description: care as usual
intervention type: Other
intervention name: community health worker support
description: usual care by professional primary care providers + emotional support by trained community health worker
arm group label: Intervention arm
intervention type: Other
intervention name: care as usual
description: care as usual is provided by professional primary care provider
arm group label: control arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)