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addressInG iNcome securITy in Primary carE (IGNITE)

This study is currently recruiting participants.
Verified November 2017 by St. Michael's Hospital, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT02459184
First Posted: June 1, 2015
Last Update Posted: November 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
  Purpose
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.

Condition Intervention
Poverty Income Social Determinants of Health Other: Income Security Health Promotion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: IGNITE (addressInG iNcome securITy in Primary carE) Study: A Pragmatic Randomized Controlled Trial

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Change in monthly income from baseline to 6 months after intervention [ Time Frame: 6 months ]
    Change in monthly income from baseline to 6 months after intervention


Secondary Outcome Measures:
  • quality of life: Change in scores on the WHO QoL-BREF and EQ-5D-5L [ Time Frame: 12 months ]
    Change in scores on the WHO QoL-BREF and EQ-5D-5L

  • quality of life (overall health, mental health, physical health): change in units on a measured scale of EQ VAS [ Time Frame: 12 months ]
    changes in units on a measured scale

  • community integration: Change in scores on the Community Integration Scale [ Time Frame: 12 months ]
    Change in scores on the Community Integration Scale

  • financial literacy: Change in scores on the Canadian Centre for Financial Literacy Personal Financial Literacy Quiz [ Time Frame: 12 months ]
    Change in scores on the Canadian Centre for Financial Literacy Personal Financial Literacy Quiz

  • co-morbidities and medication access [ Time Frame: 12 months ]
    changes to scores relating to comorbidities and medication access

  • other social determinants [ Time Frame: 12 months ]
    changes scores relating to housing and employment

  • food security [ Time Frame: 12 months ]
    changes in scores on Health Canada food security module


Estimated Enrollment: 300
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early intervention
Participants will meet with the Income Security Health Promoter immediately.
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.
Active Comparator: Late intervention
Participants will meet with the Income Security Health Promoter at 6 months.
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.

Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459184


Contacts
Contact: Andrew D Pinto, MD MSc 416-867-3728 andrew.pinto@utoronto.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Andrew D Pinto, MD MSc    416-867-3728    andrew.pinto@utoronto.ca   
Principal Investigator: Andrew D Pinto, MD MSc         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Andrew D Pinto, MD MSc St. Michael's Hospital, Toronto
  More Information

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02459184     History of Changes
Other Study ID Numbers: SMH2015
First Submitted: May 28, 2015
First Posted: June 1, 2015
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: In consultation with our institutional Research Ethics Board, we will consider release of IPD to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Michael's Hospital, Toronto:
preventive medicine
social determinants of health
primary health care
poverty
income
health promotion