Community Health Workers Against COVID19

Study Overview
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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

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

Conditions
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Covid 19, Social Isolation, Mental Health Impairment

Intervention / Treatment
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* Other: community health worker support
* Other: care as usual


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 from baseline at 6 weeks | 
| 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 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community health workers, randomized controlled trial, psychosocial impairment