Community Health Workers Against COVID19

NCT ID: NCT04426305

Last Updated: 2021-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-21

Study Completion Date

2020-10-30

Brief Summary

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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

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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

Conditions

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Covid 19 Social Isolation Mental Health Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Intervention arm

psychosocial support

Group Type EXPERIMENTAL

community health worker support

Intervention Type OTHER

usual care by professional primary care providers + emotional support by trained community health worker

control arm

care as usual

Group Type ACTIVE_COMPARATOR

care as usual

Intervention Type OTHER

care as usual is provided by professional primary care provider

Interventions

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community health worker support

usual care by professional primary care providers + emotional support by trained community health worker

Intervention Type OTHER

care as usual

care as usual is provided by professional primary care provider

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Public Health and Primary Care

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BC-07744.

Identifier Type: -

Identifier Source: org_study_id

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