Community Health Workers Against COVID19
Primary Purpose
Covid 19, Social Isolation, Mental Health Impairment
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
community health worker support
care as usual
Sponsored by

About this trial
This is an interventional supportive care trial for Covid 19 focused on measuring Community health workers, randomized controlled trial, psychosocial impairment
Eligibility Criteria
Inclusion Criteria:
- patients recruited by family practitioners based on anticipated psychosocial impact of physical distancing measures
Exclusion Criteria:
- Patients with severe psychiatric diseases (psychosis, severe depression)
Sites / Locations
- Department of Public Health and Primary Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention arm
control arm
Arm Description
psychosocial support
care as usual
Outcomes
Primary Outcome Measures
Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument)
The PROMIS Emotional Support questionnaire assesses perceived feelings of being cared for and valued as a person;
Change in patient-reported Social Isolation (based on the PROMIS® Emotional Support instrument)
The PROMIS Social Isolation questionnaire assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others.
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)
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.
Change in patient-reported anxiety (based on the PROMIS® anxiety instrument)
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04426305
Brief Title
Community Health Workers Against COVID19
Official Title
Community Health Workers Against COVID19 Tackling Psychosocial Suffering Due to Physical Distancing
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid 19, Social Isolation, Mental Health Impairment
Keywords
Community health workers, randomized controlled trial, psychosocial impairment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
psychosocial support
Arm Title
control arm
Arm Type
Active Comparator
Arm Description
care as usual
Intervention Type
Other
Intervention Name(s)
community health worker support
Intervention Description
usual care by professional primary care providers + emotional support by trained community health worker
Intervention Type
Other
Intervention Name(s)
care as usual
Intervention Description
care as usual is provided by professional primary care provider
Primary Outcome Measure Information:
Title
Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument)
Description
The PROMIS Emotional Support questionnaire assesses perceived feelings of being cared for and valued as a person;
Time Frame
change from baseline at 6 weeks
Title
Change in patient-reported Social Isolation (based on the PROMIS® Emotional Support instrument)
Description
The PROMIS Social Isolation questionnaire assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others.
Time Frame
change from baseline at 6 weeks
Title
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)
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.
Time Frame
change from baseline at 6 weeks
Title
Change in patient-reported anxiety (based on the PROMIS® anxiety instrument)
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).
Time Frame
change from baseline at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients recruited by family practitioners based on anticipated psychosocial impact of physical distancing measures
Exclusion Criteria:
Patients with severe psychiatric diseases (psychosis, severe depression)
Facility Information:
Facility Name
Department of Public Health and Primary Care
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Community Health Workers Against COVID19
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