addressInG iNcome securITy in Primary carE
IGNITE
IGNITE (addressInG iNcome securITy in Primary carE) Study: A Pragmatic Randomized Controlled Trial
1 other identifier
interventional
284
1 country
1
Brief Summary
Social processes that impact the health of individuals have been labeled the social determinants of health (SDOH). These are "the conditions in which people are born, grow, live, work and age. These circumstances are shaped by the distribution of money, power and resources at global, national and local levels". Perhaps the most important SDOH is income security, a person's actual, perceived and expected income. Our objective is to carry out a pragmatic randomized controlled trial that evaluates the impact of an income-focused health promoter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2015
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedSeptember 28, 2021
September 1, 2021
3.9 years
May 28, 2015
September 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in monthly income from baseline to 6 months after intervention
Change in monthly income from baseline to 6 months after intervention
6 months
Secondary Outcomes (7)
quality of life: Change in scores on the WHO QoL-BREF and EQ-5D-5L
12 months
quality of life (overall health, mental health, physical health): change in units on a measured scale of EQ VAS
12 months
community integration: Change in scores on the Community Integration Scale
12 months
financial literacy: Change in scores on the Canadian Centre for Financial Literacy Personal Financial Literacy Quiz
12 months
co-morbidities and medication access
12 months
- +2 more secondary outcomes
Study Arms (2)
Early intervention
EXPERIMENTALParticipants will meet with the Income Security Health Promoter immediately.
Late intervention
ACTIVE COMPARATORParticipants will meet with the Income Security Health Promoter at 6 months.
Interventions
The ISHP will work to improve the income security of participants within this study. To that end, her activities include: * Providing one-to-one case management support and ongoing follow-up to diverse low-income patients and families regarding their income security. * Developing and implementing targeted information self-help sessions, such as; banking basics, income tax submissions, and social service forms, for the target population * Developing and maintaining up-to-date detailed knowledge of financial issues and financial services affecting low-income people, and applying this knowledge in his/her work. * Assisting individual low-income patients with income security-focused interventions, including access to tax benefits, applications for income security programs such as social assistance and seniors and child benefits, and navigation of disability support programs.
Eligibility Criteria
You may qualify if:
- Age ≥18
- Lives within the Metropolitan catchment areas
- Lives in a postal code that is in the lowest income quintile, or has had a billing code specific to social assistance forms billed ever billed, or has been identified as low income based on reported family income and number of people supported by income on the "Health Equity Data"
- Patient of the Family Health team including those that are: rostered, non-rostered, refugee claimants (IFH) or uninsured seen in the FHT.
- Verified by the patient's family physician as living in poverty, a good candidate for the intervention, and the patient's family physician agrees to have a letter submitted with his/her name attached.
You may not qualify if:
- Patients who have previously worked with the Income Security Health Promoter, or are part of households of people who have previously worked with the Income Security Health Promoter.
- Patients who have no available contact information for mailing.
- Patients of any member of the investigative team.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Michael's Hospital
Toronto, Ontario, M5B1W8, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew D Pinto, MD MSc
Unity Health Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 1, 2015
Study Start
September 1, 2017
Primary Completion
July 9, 2021
Study Completion
January 31, 2022
Last Updated
September 28, 2021
Record last verified: 2021-09