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Completed

NCT Number: NCT04426305

Community Health Workers Against COVID19

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.

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Key information

Conditions

COVID 19 Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Health Impairment Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Social Behavior Social Isolation Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Public Health and Primary Care

Ghent, 9000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

community health worker support

Other

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

Care as usual

Other

care as usual is provided by professional primary care provider

Primary outcomes

  1. Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument)

    Time frame: change from baseline at 6 weeks

    The PROMIS Emotional Support questionnaire assesses perceived feelings of being cared for and valued as a person;

  2. Change in patient-reported Social Isolation (based on the PROMIS® Emotional Support instrument)

    Time frame: change from baseline at 6 weeks

    The PROMIS Social Isolation questionnaire assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others.

  3. 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)

    Time frame: change from baseline at 6 weeks

    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.

  4. Change in patient-reported anxiety (based on the PROMIS® anxiety instrument)

    Time frame: change from baseline at 6 weeks

    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).

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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