Community Health Workers Against COVID19

June 7, 2021 updated by: University Ghent

Community Health Workers Against COVID19 Tackling Psychosocial Suffering Due to Physical Distancing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Department of Public Health and Primary Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
psychosocial support
Other: community health worker support
usual care by professional primary care providers + emotional support by trained community health worker
Active Comparator: control arm
care as usual
Other: care as usual
care as usual is provided by professional primary care provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument)
Time Frame: change from baseline at 6 weeks
The PROMIS Emotional Support questionnaire assesses perceived feelings of being cared for and valued as a person;
change from baseline at 6 weeks
Change in patient-reported Social Isolation (based on the PROMIS® Emotional Support instrument)
Time Frame: change from baseline at 6 weeks
The PROMIS Social Isolation questionnaire assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others.
change from baseline at 6 weeks
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
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 from baseline at 6 weeks
Change in patient-reported anxiety (based on the PROMIS® anxiety instrument)
Time Frame: change from baseline at 6 weeks
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).
change from baseline at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2020

Primary Completion (Actual)

June 20, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-07744.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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