Community Health Workers Against COVID19

NCT04426305 | Completed DMC

• 1 other identifier: BC-07744.
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid 19; Social Isolation; Mental Health Impairment

Keywords

Community health workers; randomized controlled trial; psychosocial impairment

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Intervention arm

EXPERIMENTAL

psychosocial support

Other: community health worker support

control arm

ACTIVE COMPARATOR

care as usual

Other: care as usual

Interventions

community health worker support OTHER

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

Intervention arm

care as usual OTHER

care as usual is provided by professional primary care provider

control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients recruited by family practitioners based on anticipated psychosocial impact of physical distancing measures

You may not qualify if:

• Patients with severe psychiatric diseases (psychosis, severe depression)

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Department of Public Health and Primary Care

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

COVID-19; Social Isolation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: May 21, 2020
• Primary Completion: June 20, 2020
• Study Completion: October 30, 2020
• Last Updated: June 8, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

BE (1)