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Integrated Health and Social Support for Emotional Distress During COVID-19 (ANTICIPATE Trial)

N/A
Recruiting
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

ANTICIPATE Trial Summary

This trial is looking at whether providing support to patients' social needs (e.g. income, housing, food security) can help reduce emotional distress during the COVID-19 pandemic.

Who is the study for?
This trial is for patients at high risk during the pandemic, specifically those living in poverty or without stable housing, and with chronic conditions like diabetes or serious mental illnesses such as schizophrenia. It's conducted by the University of Toronto and involves personalized support from a System Navigator.Check my eligibility
What is being tested?
The study tests if proactive identification of vulnerable individuals and providing them with a System Navigator to address their health and social needs can reduce emotional distress compared to usual care. The focus is on improving quality of life during COVID-19.See study design
What are the potential side effects?
Since this intervention involves non-medical support (like help finding resources), traditional side effects associated with medications are not expected. However, there may be indirect effects on participants' stress levels or mental health.

ANTICIPATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Emotional Distress on the PROMIS-29 Profile c2.1 Scale
Secondary outcome measures
COVID related outcomes (patient-reported questionnaire built for this study)
Mortality related to COVID-19 and all cause mortality
Number of hospitalizations related to COVID-19 and all cause mortality
+1 more

ANTICIPATE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - System NavigatorExperimental Treatment1 Intervention
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
Group II: Tailored list of community resourcesActive Control1 Intervention
Control group will be provided a tailored list of community resources.

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Who is running the clinical trial?

Ontario Medical AssociationOTHER
3 Previous Clinical Trials
19,297 Total Patients Enrolled
Unity Health TorontoLead Sponsor
539 Previous Clinical Trials
447,585 Total Patients Enrolled
2 Trials studying Emotional Distress
115 Patients Enrolled for Emotional Distress
Platinum Medical ClinicUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care
2022. "At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05197608.
~58 spots leftby Apr 2025
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