NCT02459184

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
2.3 years until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

3.9 years

First QC Date

May 28, 2015

Last Update Submit

September 27, 2021

Conditions

Keywords

preventive medicinesocial determinants of healthprimary health carepovertyincomehealth promotion

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

EXPERIMENTAL

Participants will meet with the Income Security Health Promoter immediately.

Other: Income Security Health Promotion

Late intervention

ACTIVE COMPARATOR

Participants will meet with the Income Security Health Promoter at 6 months.

Other: Income Security Health Promotion

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.

Early interventionLate intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Andrew D Pinto, MD MSc

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

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

Locations