Proactive support for vulnerable individuals during COVID-19
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
NA · Unity Health Toronto · NCT05197608
This study is testing whether having a System Navigator help patients at high risk during COVID-19 can reduce their emotional stress and better meet their health and social needs compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05197608 on ClinicalTrials.gov |
What this trial studies
This randomized control trial investigates a proactive approach to identify patients at high risk during the COVID-19 pandemic and evaluates the effectiveness of a System Navigator in a primary health care setting. The System Navigator collaborates with patients to address their biological, psychological, and social needs, such as income and housing security. The study aims to determine if this proactive engagement reduces emotional distress related to managing complex health conditions and unmet social needs compared to standard care. Approximately 180 patients from primary care clinics within the University of Toronto Practice-Based Research Network will participate in this trial.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 and older who are at-risk and vulnerable, with chronic conditions or serious mental illnesses, and who may be living in poverty or facing housing instability.
Not a fit: Patients who are not at-risk, do not have chronic conditions or serious mental illnesses, or are unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce emotional distress and improve the quality of life for vulnerable patients during the pandemic.
How similar studies have performed: Other studies have shown success with proactive engagement strategies in health care settings, indicating potential for positive outcomes in similar approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At-risk and vulnerable patients of primary care organizations who are 60+ AND have one or more of: 1. chronic condition (diabetes, CHF, CAD, COPD or asthma) 2. serious mental illness (schizophrenia or bipolar disorder) 3. anticipated to live in poverty and/or be homeless/underhoused Exclusion Criteria: * patients unable to provide informed consent
Where this trial is running
Toronto, Ontario
- St. Michael's Hospital — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Andrew D Pinto, MD, MSc
- Email: andrew.pinto@utoronto.ca
- Phone: 416-864-6060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Emotional Distress, Quality of Life, Mental Health, Social Determinants of Health, COVID-19, primary health care, proactive care