Community Health Workers Against COVID19

Social Isolation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426305
• Other study ID #: BC-07744.
• Status: Completed
• Phase: N/A
• Start date: May 21, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: May 2020
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 30, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Covid 19
• Mental Health Impairment
• Social Isolation

Intervention

Other:
• community health worker support
usual care by professional primary care providers + emotional support by trained community health worker
• care as usual
care as usual is provided by professional primary care provider

Locations

Country	Name	City	State
Belgium	Department of Public Health and Primary Care	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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