BehaviorNCT03481270
The Oakland Men's Health Disparities Study
A study testing Concordant in people with Behavior and Cardiovascular Risk Factor, run by Stanford University at 1 site in United States.
Trial summary
Reducing racial disparities in health outcomes is a major policy concern in the United States. Although there has been recent progress to close the gap, black men continue to experience earlier morbidity and mortality from preventable and manageable medical conditions, and live on average 4.2 years less than their… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Behavior, Cardiovascular Risk Factor, Influenza
- What is being tested?
- Concordant
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,374 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2017to 3 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American male adults
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbershops / Fleamarkets
Oakland, California, 94577
About this study
Reducing racial disparities in health outcomes is a major policy concern in the United States. Although there has been recent progress to close the gap, black men continue to experience earlier morbidity and mortality from preventable and manageable medical conditions, and live on average 4.2 years less than their white male peers. An oft-prescribed solution to close this stubborn gap is to increase the diversity of the healthcare workforce. Another common policy tool to increase take-up of preventative healthcare services is financial incentives. In this randomized evaluation, we will estimate the effects of financial incentives and a racially concordant physician on the uptake of preventive health services in Oakland, California.
- Conditions
- Behavior, Cardiovascular Risk Factor, Influenza
- Being tested
- Concordant
- Medical subject headings
- Behavior, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConcordantBehavioural
We will be randomizing across providers - we are particularly interested in racial concordance.
| Study group | Role | What they receive |
|---|---|---|
| Discordant | Placebo comparator | Does not receive the concordant provider. Receives: Behavioral: Concordant |
| Concordant | Experimental | The intervention is that the subject receives the concordant provider. Receives: Behavioral: Concordant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Take-up of Preventive Services (Post-consultation)
Take-up of preventative services was scored as either zero (did not utilize any post-consultation services) or 1 (utilized at least 1 post-consultation service). Four non-incentivized post-consultation preventive services were offered (for BMI, blood pressure, cholesterol, and/or diabetes); the subject had the opportunity to select service(s) after meeting with their assigned doctor.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start14 Oct 2017
- Primary completion3 Mar 2018
- Study completion3 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BehaviorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcella Alsan, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481270
- Sponsor's protocol ID
- 36255
- Status last verified
- Oct 2019
- First submitted
- 5 Oct 2017
- Last updated
- 25 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oakland Men's Health Disparities Study
- ClinicalTrials.gov ID
- NCT03481270
- Acronym / sponsor ID
- 36255
- Conditions
- Behavior, Cardiovascular Risk Factor, Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,374 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 14 Oct 2017 (actual)
- Primary completion
- 3 Mar 2018 (actual)
- Study completion
- 3 Mar 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 25 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reducing racial disparities in health outcomes is a major policy concern in the United States. Although there has been recent progress to close the gap, black men continue to experience earlier morbidity and mortality from preventable and manageable medical conditions, and live on average 4.2 years less than their white male peers. An oft-prescribed solution to close this stubborn gap is to increase the diversity of the healthcare workforce. Another common policy tool to increase take-up of preventative healthcare services is financial incentives. In this randomized evaluation, we will estimate the effects of financial incentives and a racially concordant physician on the uptake of preventive health services in Oakland, California.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Discordant | Placebo comparator | Behavioral: ConcordantDoes not receive the concordant provider. |
| Concordant | Experimental | Behavioral: ConcordantThe intervention is that the subject receives the concordant provider. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- African American male adults
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| ConcordantWe will be randomizing across providers - we are particularly interested in racial concordance. | Behavioural | Concordant, Discordant |
Primary outcome
Average Take-up of Preventive Services (Post-consultation)
Time frame: 1 day
Take-up of preventative services was scored as either zero (did not utilize any post-consultation services) or 1 (utilized at least 1 post-consultation service). Four non-incentivized post-consultation preventive services were offered (for BMI, blood pressure, cholesterol, and/or diabetes); the subject had the opportunity to select service(s) after meeting with their assigned doctor.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concordant in people with Behavior and Cardiovascular Risk Factor, run by Stanford University at 1 site in United States.
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: finished, as of the sponsor's last update on 25 Oct 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Take-up of Preventive Services (Post-consultation) (time frame: 1 day). 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 25 Oct 2019.