Emotional DistressANTICIPATENCT05197608
At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care
A study testing System Navigator and Tailored list of resources in people with Emotional Distress and Quality of Life, run by Unity Health Toronto at 1 site in Canada.
Trial summary
This randomized control trial aims to explore a data-driven, proactive approach to identifying patients at greatest risk during the pandemic, and assess the impact of an embedded System Navigator in a primary health care setting. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional Distress, Quality of Life, Mental Health
- What is being tested?
- System Navigator and Tailored list of resources
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- 25 Feb 2022to Mar 2024
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At-risk and vulnerable patients of primary care organizations who are 60+ AND have one or more of:
- chronic condition (diabetes, CHF, CAD, COPD or asthma)
- serious mental illness (schizophrenia or bipolar disorder)
- anticipated to live in poverty and/or be homeless/underhoused
Who cannot join
- patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Andrew D Pinto, MD MSc, 416-864-6060 ext. 77350, andrew.pinto@utoronto.ca
About this study
Official title: At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care (ANTICIPATE): a Pragmatic Randomized Controlled Trial
This randomized control trial aims to explore a data-driven, proactive approach to identifying patients at greatest risk during the pandemic, and assess the impact of an embedded System Navigator in a primary health care setting. The System Navigator works one-on-one with patients to identify and provide support to their biological, psychological and social needs (e.g. income, housing, food security). Investigators are doing this study to find out whether proactive identification of vulnerable patients and linking to a System Navigator leads to reduction in emotional distress associated with managing complex health conditions and unmet social needs during COVID-19, compared to usual care.
Investigators will involve approximately 180 patients from primary care clinics that are a part of the University of Toronto Practice-Based Research Network (UTOPIAN). The information from this study will be used to help us understand how proactive engagement within a primary health setting can help to improve the health of patients during COVID-19, and beyond.
- Conditions
- Emotional Distress, Quality of Life, Mental Health
- Being tested
- System Navigator, Tailored list of resources
- Keywords
- Social Determinants of Health, COVID-19, primary health care, proactive care
- Medical subject headings
- Psychological Well-Being, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
System NavigatorOther
Participants will be connected to a System Navigator, who is a trained staff embedded within their primary health clinic to support and help navigate biological, psychological and social needs in proactively identified vulnerable patients.
Tailored list of resourcesOther
Control group will be provided a tailored list of resources
| Study group | Role | What they receive |
|---|---|---|
| Intervention - System Navigator | Experimental | The intervention group will be connected to a system navigator who is a trained staff member embedded within the primary health clinic team with a focus to address participant's biological, psychological and social needs.
Working with the System Navigator will mean:
* Discussing patients' current health status and concerns
* Receiving support on management of chronic diseases and mental health including connection to local resources e.g. counseling, harm reduction, crisis support services
* Receiving information about benefits that they may be entitled to and learning about free services
* Receiving help from the System Navigator on forms or letters that are required to access resources Receives: Other: System Navigator |
| Tailored list of community resources | Active comparator | Control group will be provided a tailored list of community resources. Receives: Other: Tailored list of resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Distress on the PROMIS-29 Profile c2.1 Scale
Measure of emotional distress as measured by anxiety and depression systems
Measured: 3 months
Secondary outcomes (4)
Social needs met
Number of social needs experienced by patients from a list (yes/no) at baseline and 3 month follow up
Measured: 3 months
COVID related outcomes (patient-reported questionnaire built for this study)
Patient-reported COVID-related clinic or hospitalization visits and COVID vaccine status captured at baseline and 3 month follow up
Measured: 3 months
Mortality related to COVID-19 and all cause mortality
Mortality (number of deaths) data obtained from administrative data source
Measured: 12 months
Number of hospitalizations related to COVID-19 and all cause mortality
hospitalization (number of hospitalizations) data obtained from administrative data source
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start25 Feb 2022
- Primary completionJan 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into "intervention" or "control" group. The intervention group will be connected to a system navigator who is a trained staff member embedded within the primary health clinic team with a focus to address participant's biological, psychological and social needs. Control group will be provided a tailored list of community resources.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Ontario Medical Association, Platinum Medical Clinic, Markham Family Health Team, Barrie and Community Family Health Team, University of Toronto Practice Based Research Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197608
- Sponsor's protocol ID
- SMH 20-140
- Acronym
- ANTICIPATE
- Status last verified
- Nov 2023
- First submitted
- 27 Sep 2021
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care (ANTICIPATE): a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05197608
- Acronym / sponsor ID
- ANTICIPATE / SMH 20-140
- Conditions
- Emotional Distress, Quality of Life, Mental Health
- Keywords
- Social Determinants of Health, COVID-19, primary health care, proactive care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Ontario Medical Association, Platinum Medical Clinic, Markham Family Health Team, Barrie and Community Family Health Team, University of Toronto Practice Based Research Network
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 19 Jan 2022 (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.
This randomized control trial aims to explore a data-driven, proactive approach to identifying patients at greatest risk during the pandemic, and assess the impact of an embedded System Navigator in a primary health care setting. The System Navigator works one-on-one with patients to identify and provide support to their biological, psychological and social needs (e.g. income, housing, food security). Investigators are doing this study to find out whether proactive identification of vulnerable patients and linking to a System Navigator leads to reduction in emotional distress associated with managing complex health conditions and unmet social needs during COVID-19, compared to usual care.
Investigators will involve approximately 180 patients from primary care clinics that are a part of the University of Toronto Practice-Based Research Network (UTOPIAN). The information from this study will be used to help us understand how proactive engagement within a primary health setting can help to improve the health of patients during COVID-19, and beyond.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into "intervention" or "control" group. The intervention group will be connected to a system navigator who is a trained staff member embedded within the primary health clinic team with a focus to address participant's biological, psychological and social needs. Control group will be provided a tailored list of community resources.
| Arm | Type | Receives |
|---|---|---|
| Intervention - System Navigator | Experimental | Other: System NavigatorThe intervention group will be connected to a system navigator who is a trained staff member embedded within the primary health clinic team with a focus to address participant's biological, psychological and social needs. Working with the System Navigator will mean: * Discussing patients' current health status and concerns * Receiving support on management of chronic diseases and mental health including connection to local resources e.g. counseling, harm reduction, crisis support services * Receiving information about benefits that they may be entitled to and learning about free services * Receiving help from the System Navigator on forms or letters that are required to access resources |
| Tailored list of community resources | Active comparator | Other: Tailored list of resourcesControl group will be provided a tailored list of community resources. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At-risk and vulnerable patients of primary care organizations who are 60+ AND have one or more of:
Key exclusion criteria (1 listed)
- patients unable to provide informed consent
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 |
|---|---|---|
| System NavigatorParticipants will be connected to a System Navigator, who is a trained staff embedded within their primary health clinic to support and help navigate biological, psychological and social needs in proactively identified vulnerable patients. | Other | Intervention - System Navigator |
| Tailored list of resourcesControl group will be provided a tailored list of resources | Other | Tailored list of community resources |
Primary outcome
Emotional Distress on the PROMIS-29 Profile c2.1 Scale
Time frame: 3 months
Measure of emotional distress as measured by anxiety and depression systems
4 secondary outcomes
Social needs met
Time frame: 3 months
COVID related outcomes (patient-reported questionnaire built for this study)
Time frame: 3 months
Mortality related to COVID-19 and all cause mortality
Time frame: 12 months
Number of hospitalizations related to COVID-19 and all cause mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing System Navigator and Tailored list of resources in people with Emotional Distress and Quality of Life, run by Unity Health Toronto at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew D Pinto, MD, MSc (416-864-6060 ext. 77350, andrew.pinto@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Distress on the PROMIS-29 Profile c2.1 Scale (time frame: 3 months). 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 4 Dec 2023.