Covid 19NCT04426305
Community Health Workers Against COVID19
A study testing community health worker support and care as usual in people with Covid 19 and Social Isolation, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid 19, Social Isolation, Mental Health Impairment
- What is being tested?
- community health worker support and care as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- 21 May 2020to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients recruited by family practitioners based on anticipated psychosocial impact of physical distancing measures
Who cannot join
- Patients with severe psychiatric diseases (psychosis, severe depression)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Health Workers Against COVID19 Tackling Psychosocial Suffering Due to Physical Distancing
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.
Read the 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
- Conditions
- Covid 19, Social Isolation, Mental Health Impairment
- Being tested
- community health worker support, care as usual
- Keywords
- Community health workers, randomized controlled trial, psychosocial impairment
- Medical subject headings
- COVID-19, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community health worker supportOther
usual care by professional primary care providers + emotional support by trained community health worker
care as usualOther
care as usual is provided by professional primary care provider
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | psychosocial support Receives: Other: community health worker support |
| control arm | Active comparator | care as usual Receives: Other: care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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.
Measured: 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.
Measured: 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).
Measured: change from baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start21 May 2020
- Primary completion20 Jun 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid 19Studies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426305
- Sponsor's protocol ID
- BC-07744.
- Status last verified
- May 2020
- First submitted
- 3 Jun 2020
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Workers Against COVID19 Tackling Psychosocial Suffering Due to Physical Distancing
- ClinicalTrials.gov ID
- NCT04426305
- Acronym / sponsor ID
- BC-07744.
- Conditions
- Covid 19, Social Isolation, Mental Health Impairment
- Keywords
- Community health workers, randomized controlled trial, psychosocial impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: community health worker supportpsychosocial support |
| control arm | Active comparator | Other: care as usualcare as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients recruited by family practitioners based on anticipated psychosocial impact of physical distancing measures
Key exclusion criteria (1 listed)
- Patients with severe psychiatric diseases (psychosis, severe depression)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| community health worker supportusual care by professional primary care providers + emotional support by trained community health worker | Other | Intervention arm |
| care as usualcare as usual is provided by professional primary care provider | Other | control arm |
Primary outcome
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;
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community health worker support and care as usual in people with Covid 19 and Social Isolation, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument) (time frame: change from baseline at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.