addressInG iNcome securITy in Primary carE

Social Determinants of Health Clinical Trial

— IGNITE  

Official title:

IGNITE (addressInG iNcome securITy in Primary carE) Study: A Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02459184
• Other study ID #: SMH2015
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: September 2021
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study aims to answer the question: What is the impact of an income security health promotion service based in a primary care setting on the income security of people living in poverty? We hypothesize that an income security health promotion service for adults living in poverty will increase monthly income relative to usual care. We will carry out a pragmatic randomized controlled trial that evaluates the impact of such a new service focused on income security health promotion. The St. Michael's Hospital Academic Family Health Team has received ongoing funding from the Ministry of Health and Long-Term Care (MOHLTC) to support this service. The primary outcome is income security, and secondary outcomes include quality of life, financial literacy and community integration.

Population - Adults living in poverty Intervention - Income security health promotion Control

• Usual care Outcome - Primary: Improvement in income per month in the intervention group at 6 months (post-intervention) compared to income in control group at 6 months (pre-intervention). Secondary: quality of life, self-rated health, community engagement.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 284
• Est. completion date: January 31, 2022
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Income
• Poverty
• Social Determinants of Health

Intervention

Other:
• Income Security Health Promotion
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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	quality of life: Change in scores on the WHO QoL-BREF and EQ-5D-5L	Change in scores on the WHO QoL-BREF and EQ-5D-5L	12 months
Secondary	quality of life (overall health, mental health, physical health): change in units on a measured scale of EQ VAS	changes in units on a measured scale	12 months
Secondary	community integration: Change in scores on the Community Integration Scale	Change in scores on the Community Integration Scale	12 months
Secondary	financial literacy: Change in scores on the Canadian Centre for Financial Literacy Personal Financial Literacy Quiz	Change in scores on the Canadian Centre for Financial Literacy Personal Financial Literacy Quiz	12 months
Secondary	co-morbidities and medication access	changes to scores relating to comorbidities and medication access	12 months
Secondary	other social determinants	changes scores relating to housing and employment	12 months
Secondary	food security	changes in scores on Health Canada food security module	12 months