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Community Health Workers Against COVID19

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04426305
Enrollment
140
Registered
2020-06-11
Start date
2020-05-21
Completion date
2020-10-30
Last updated
2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid 19, Mental Health Impairment, Social Isolation

Keywords

Community health workers, randomized controlled trial, psychosocial impairment

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

Interventions

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

OTHERcare as usual

care as usual is provided by professional primary care provider

Sponsors

University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument)change from baseline at 6 weeksThe 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 weeksThe 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 weeksThe 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 weeksThe 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).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026