Community Health Workers Against COVID19

Not Applicable

Completed

• Conditions: Social Isolation; Covid 19; Mental Health Impairment
• Interventions: Other: care as usual; Other: community health worker support

• Registration Number: NCT04426305
• Lead Sponsor: University Ghent

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

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-21
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Primary Completion: 2020-06-20
• Study Completion: 2020-10-30
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control arm	care as usual	care as usual
Intervention arm	community health worker support	psychosocial support

Primary Outcome Measures

Name	Time	Method
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).
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 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 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;

Trial Locations

Locations (1)

Department of Public Health and Primary Care; 🇧🇪 Ghent, Belgium