Community Health Workers Against COVID19

Sponsor

University Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT04426305

Collaborator

(none)

140

Enrollment

Location

Arms

5.3

Actual Duration (Months)

26.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid 19 Social Isolation Mental Health Impairment	Other: community health worker support Other: care as usual	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 21, 2020

Actual Primary Completion Date :

Jun 20, 2020

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument) [change from baseline at 6 weeks]
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) [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 in patient-reported Ability to participate in social roles and activities (based on the PROMIS® ability to participate in social roles and activities instrument) [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 in patient-reported anxiety (based on the PROMIS® anxiety instrument) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Public Health and Primary Care	Ghent		Belgium	9000

Sponsors and Collaborators

University Ghent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Ghent

ClinicalTrials.gov Identifier:

NCT04426305

Other Study ID Numbers:

BC-07744.

First Posted:

Jun 11, 2020

Last Update Posted:

Jun 8, 2021

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Ghent

Community health workers

randomized controlled trial

psychosocial impairment

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jun 8, 2021