PovertySPARKNCT04461080
Screening for Poverty And Related Social Determinants to Improve Knowledge of and Links to Resources (SPARK)
A study testing Community Health Worker in people with Poverty, run by Unity Health Toronto.
Trial summary
The SPARK RCT will test the impact of engagement with a Community Health Worker who is embedded in interprofessional primary care teams on change in estimated annual income at 6 months for people living in poverty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Poverty
- What is being tested?
- Community Health Worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years old AND live in a household with an income below the Low-Income Cut-OFF AND agree to receive assistance with social needs
Who cannot join
- Has worked with a similar CHW or intervention in the past 1 year.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Screening for Poverty And Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK): a Randomized Controlled Study
The SPARK RCT will test the impact of engagement with a Community Health Worker who is embedded in interprofessional primary care teams on change in estimated annual income at 6 months for people living in poverty.
Read the detailed description
Population: Patients seen by interprofessional primary care teams who are living on estimated annual incomes that are below the Canadian Low-Income Cut-Off (LICO)
Intervention: A Community Health Worker who implements an intervention that addresses a number of social needs, including improving income security, access to prescription medications, access to housing, reducing social isolation, paying for utilities and access to transportation
Control: Information on community resources on social needs
Outcome: Change in estimated annual income between baseline and at 6 months
- Conditions
- Poverty
- Being tested
- Community Health Worker
- Keywords
- poverty, income, social determinants of health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health WorkerBehavioural
Trained Community Health Worker
| Study group | Role | What they receive |
|---|---|---|
| Integrated care promoter | Experimental | Patients who are randomized to the intervention group will be connected with a trained Community Health Worker (CHW). The CHW is a peer with lived-experience of system navigation that could have a background in social work, health promotion or community work. All CHWs will receive 2 weeks of training to assist participants with social needs. Receives: Behavioral: Community Health Worker |
| Information on community resources | Active comparator | Patients randomized to the control group will receive a list of tailored written information. Receives: Behavioral: Community Health Worker |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in estimated annual income
The primary outcome will be change in estimated annual income, assessed at baseline and at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study startAug 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (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.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- parallel, two-arm 1:1 individual participant allocation randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial University of Newfoundland, Dalhousie University, University of Manitoba, University of Saskatchewan
- Responsible party
- Sponsor
- Investigators
- Andrew D Pinto, MD MSc, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461080
- Sponsor's protocol ID
- UpstreamLab2020-1
- Acronym
- SPARK
- Status last verified
- Jun 2024
- First submitted
- 2 Jul 2020
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study will be made available to qualified researchers with academic interest in primary care health equity research. Data will only be made available to interested parties after all applicable agreements have been executed.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Poverty And Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK): a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04461080
- Acronym / sponsor ID
- SPARK / UpstreamLab2020-1
- Conditions
- Poverty
- Keywords
- poverty, income, social determinants of health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Memorial University of Newfoundland, Dalhousie University, University of Manitoba, University of Saskatchewan
- Study start
- Aug 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Jul 2020 (actual)
- 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.
The SPARK RCT will test the impact of engagement with a Community Health Worker who is embedded in interprofessional primary care teams on change in estimated annual income at 6 months for people living in poverty.
Detailed description
Population: Patients seen by interprofessional primary care teams who are living on estimated annual incomes that are below the Canadian Low-Income Cut-Off (LICO)
Intervention: A Community Health Worker who implements an intervention that addresses a number of social needs, including improving income security, access to prescription medications, access to housing, reducing social isolation, paying for utilities and access to transportation
Control: Information on community resources on social needs
Outcome: Change in estimated annual income between baseline and at 6 months
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel, two-arm 1:1 individual participant allocation randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Integrated care promoter | Experimental | Behavioral: Community Health WorkerPatients who are randomized to the intervention group will be connected with a trained Community Health Worker (CHW). The CHW is a peer with lived-experience of system navigation that could have a background in social work, health promotion or community work. All CHWs will receive 2 weeks of training to assist participants with social needs. |
| Information on community resources | Active comparator | Behavioral: Community Health WorkerPatients randomized to the control group will receive a list of tailored written information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18+ years old AND live in a household with an income below the Low-Income Cut-OFF AND agree to receive assistance with social needs
Key exclusion criteria (1 listed)
- Has worked with a similar CHW or intervention in the past 1 year.
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 |
|---|---|---|
| Community Health WorkerTrained Community Health Worker | Behavioural | Information on community resources, Integrated care promoter |
Primary outcome
change in estimated annual income
Time frame: 6 months
The primary outcome will be change in estimated annual income, assessed at baseline and at 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Website for the SPARK StudyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data from this study will be made available to qualified researchers with academic interest in primary care health equity research. Data will only be made available to interested parties after all applicable agreements have been executed.
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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
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker in people with Poverty, run by Unity Health Toronto.
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 1 inclusion and 1 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 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Antonio Cassano, BA (416-864-6060 ext. 40218, antonio.cassano@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in estimated annual income (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 18 Jun 2024.