Clinical trial NCT04426305: Community Health Workers Against COVID19
Official title: Community Health Workers Against COVID19 Tackling Psychosocial Suffering Due to Physical Distancing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid 19
Social Isolation
Mental Health Impairment
Keywords: Community health workers
randomized controlled trial
psychosocial impairment
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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)

Primary outcomes:
measure: Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument)
timeFrame: change from baseline at 6 weeks
measure: Change in patient-reported Social Isolation (based on the PROMIS® Emotional Support instrument)
timeFrame: change from baseline at 6 weeks
measure: 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)
timeFrame: change from baseline at 6 weeks
measure: Change in patient-reported anxiety (based on the PROMIS® anxiety instrument)
timeFrame: change from baseline at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Public Health and Primary Care
Study officials:
References: