Cardiovascular DiseasesEarly Phase 1AACP-CVDNCT01335022
African American Community Health Project on Cardiovascular Disease
A Early Phase 1 study testing lecture in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by Northwestern University at 1 site in United States.
Trial summary
The investigators seek to demonstrate that interactive physician-led education through partnership with an African American church will improve awareness and knowledge of cardiovascular disease in the African American community and will result in objective improvement in major risk factors associated with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor
- What is being tested?
- lecture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2010
- Phase
- Early Phase 1
- 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
- African American adults > 18 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Heritage International Christian Church
Chicago, Illinois, 60639
About this study
Official title: African American Community Health Project on Cardiovascular Disease (AACP-CVD)
The investigators seek to demonstrate that interactive physician-led education through partnership with an African American church will improve awareness and knowledge of cardiovascular disease in the African American community and will result in objective improvement in major risk factors associated with cardiovascular disease (CVD).
Read the detailed description
Cardiovascular disease causes significant morbidity and mortality in the African American community. Among African Americans adults almost 1/3 have hypertension, 1/10 have heart disease, 1/20 have coronary heart disease, and 1/30 have had a stroke. Compared to their Caucasian American counterparts, African Americans are 3 times more times as likely to die from cardiovascular diseases than Caucasians, 1.5 times more likely to die from heart failure, and 1.8 times more likely to die from stroke. In addition, both lower socioeconomic position and minority race/ethnicity are associated with poorer health and shortened survival. These alarming statistics highlight the health disparities in the African American community. In our study, the investigators propose that interactive physician-led education through partnership with an African American church will improve awareness and knowledge of CVD in the African American community and will result in objective improvement in major risk factors associated with cardiovascular disease.
- Being tested
- lecture
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lectureBehavioural
6 lectures on cardiovascular disease covering obesity, diet \& exercise, smoking cessation, coronary artery disease, hypertension, heart failure, diabetes, peripheral vascular disease, and stroke.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular Disease Education | Experimental | 6 lectures on cardiovascular disease were given over a 2 month time period Receives: Behavioral: lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Change after educational series
Measured: 2 months
Weight
Change after educational series
Measured: 2 months
Body mass index
Change after educational series
Measured: 2 months
Waist Circumference
Change after educational series
Measured: 2 months
Multiple choice test on cardiovascular disease
The multiple choice test is a 25-question test on general cardiovascular disease knowledge. It covers diet, exercise, smoking, obesity, coronary artery disease, heart failure, diabetes, stroke, and peripheral artery disease. This test is given at the start of the study and after the educational intervention. The overall test scores are compared by percentage correct. The individual questions are examined for group knowledge level on a particular topic. For example, the % correct of the group on a question about diabetes would reflect knowledge of diabetes.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Investigators
- Donald M Lloyd-Jones, MD, ScM, Principal investigator, Northwestern UniversityWilliam J Mosley II, MD, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335022
- Sponsor's protocol ID
- STU00035483
- Acronym
- AACP-CVD
- Status last verified
- Oct 2023
- First submitted
- 4 Apr 2011
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African American Community Health Project on Cardiovascular Disease (AACP-CVD)
- ClinicalTrials.gov ID
- NCT01335022
- Acronym / sponsor ID
- AACP-CVD / STU00035483
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Apr 2011 (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.
The investigators seek to demonstrate that interactive physician-led education through partnership with an African American church will improve awareness and knowledge of cardiovascular disease in the African American community and will result in objective improvement in major risk factors associated with cardiovascular disease (CVD).
Detailed description
Cardiovascular disease causes significant morbidity and mortality in the African American community. Among African Americans adults almost 1/3 have hypertension, 1/10 have heart disease, 1/20 have coronary heart disease, and 1/30 have had a stroke. Compared to their Caucasian American counterparts, African Americans are 3 times more times as likely to die from cardiovascular diseases than Caucasians, 1.5 times more likely to die from heart failure, and 1.8 times more likely to die from stroke. In addition, both lower socioeconomic position and minority race/ethnicity are associated with poorer health and shortened survival. These alarming statistics highlight the health disparities in the African American community. In our study, the investigators propose that interactive physician-led education through partnership with an African American church will improve awareness and knowledge of CVD in the African American community and will result in objective improvement in major risk factors associated with cardiovascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular Disease Education | Experimental | Behavioral: lecture6 lectures on cardiovascular disease were given over a 2 month time period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- African American adults > 18 years old
Key exclusion criteria (0 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 |
|---|---|---|
| lecture6 lectures on cardiovascular disease covering obesity, diet \& exercise, smoking cessation, coronary artery disease, hypertension, heart failure, diabetes, peripheral vascular disease, and stroke. | Behavioural | Cardiovascular Disease Education |
Primary outcome
Blood pressure
Time frame: 2 months
Change after educational series
Weight
Time frame: 2 months
Change after educational series
Body mass index
Time frame: 2 months
Change after educational series
Waist Circumference
Time frame: 2 months
Change after educational series
Multiple choice test on cardiovascular disease
Time frame: 2 months
The multiple choice test is a 25-question test on general cardiovascular disease knowledge. It covers diet, exercise, smoking, obesity, coronary artery disease, heart failure, diabetes, stroke, and peripheral artery disease. This test is given at the start of the study and after the educational intervention. The overall test scores are compared by percentage correct. The individual questions are examined for group knowledge level on a particular topic. For example, the % correct of the group on a question about diabetes would reflect knowledge of diabetes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Study WebsiteLink provided by the sponsor.
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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.
Donald M Lloyd-Jones, MD, ScM principal investigator
Northwestern University
William J Mosley II, MD study director
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing lecture in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by Northwestern 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 0 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 27 Oct 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood pressure (time frame: 2 months). The study lists 5 primary outcomes in all. 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 27 Oct 2023.