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Clinical Trials/NCT05197608
NCT05197608
Recruiting
N/A

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

Unity Health Toronto1 site in 1 country180 target enrollmentFebruary 25, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Emotional Distress
Sponsor
Unity Health Toronto
Enrollment
180
Locations
1
Primary Endpoint
Emotional Distress on the PROMIS-29 Profile c2.1 Scale
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
February 25, 2022
End Date
March 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • patients unable to provide informed consent

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Social needs met(3 months)
  • COVID related outcomes (patient-reported questionnaire built for this study)(3 months)
  • Mortality related to COVID-19 and all cause mortality(12 months)
  • Number of hospitalizations related to COVID-19 and all cause mortality(12 months)

Study Sites (1)

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