PovertyIGNITENCT02459184
addressInG iNcome securITy in Primary carE
A study testing Income Security Health Promotion in people with Poverty and Income, run by Unity Health Toronto at 1 site in Canada.
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". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Poverty, Income, Social Determinants of Health
- What is being tested?
- Income Security Health Promotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IGNITE (addressInG iNcome securITy in Primary carE) Study: A Pragmatic Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Poverty, Income, Social Determinants of Health
- Being tested
- Income Security Health Promotion
- Keywords
- preventive medicine, social determinants of health, primary health care, poverty, income, health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Income Security Health PromotionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Experimental | Participants will meet with the Income Security Health Promoter immediately. Receives: Other: Income Security Health Promotion |
| Late intervention | Active comparator | Participants will meet with the Income Security Health Promoter at 6 months. Receives: Other: Income Security Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in monthly income from baseline to 6 months after intervention
Change in monthly income from baseline to 6 months after intervention
Measured: 6 months
Secondary outcomes (7)
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
Measured: 12 months
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
Measured: 12 months
community integration: Change in scores on the Community Integration Scale
Change in scores on the Community Integration Scale
Measured: 12 months
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
Measured: 12 months
co-morbidities and medication access
changes to scores relating to comorbidities and medication access
Measured: 12 months
other social determinants
changes scores relating to housing and employment
Measured: 12 months
food security
changes in scores on Health Canada food security module
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study start1 Sep 2017
- Primary completion9 Jul 2021
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PovertyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew D Pinto, MD MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459184
- Sponsor's protocol ID
- SMH2015
- Acronym
- IGNITE
- Status last verified
- Sep 2021
- First submitted
- 28 May 2015
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In consultation with our institutional Research Ethics Board, we will consider release of IPD to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGNITE (addressInG iNcome securITy in Primary carE) Study: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02459184
- Acronym / sponsor ID
- IGNITE / SMH2015
- Conditions
- Poverty, Income, Social Determinants of Health
- Keywords
- preventive medicine, social determinants of health, primary health care, poverty, income, health promotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intervention | Experimental | Other: Income Security Health PromotionParticipants will meet with the Income Security Health Promoter immediately. |
| Late intervention | Active comparator | Other: Income Security Health PromotionParticipants will meet with the Income Security Health Promoter at 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Income Security Health PromotionThe 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. | Other | Early intervention, Late intervention |
Primary outcome
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
7 secondary outcomes
quality of life: Change in scores on the WHO QoL-BREF and EQ-5D-5L
Time frame: 12 months
quality of life (overall health, mental health, physical health): change in units on a measured scale of EQ VAS
Time frame: 12 months
community integration: Change in scores on the Community Integration Scale
Time frame: 12 months
financial literacy: Change in scores on the Canadian Centre for Financial Literacy Personal Financial Literacy Quiz
Time frame: 12 months
co-morbidities and medication access
Time frame: 12 months
other social determinants
Time frame: 12 months
food security
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Undecided. In consultation with our institutional Research Ethics Board, we will consider release of IPD to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D Pinto, MD MSc principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Income Security Health Promotion in people with Poverty and Income, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in monthly income from baseline to 6 months after intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.