Cardiovascular DiseasesNCT00948714
Support for Cardiovascular Health in African American Primary Care Patients
A study testing Peer Coach Phone Calls, Health Educator Visits and written materials in people with Cardiovascular Diseases and Blood Pressure, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Project Overview: Poor hypertension control has dire consequences for the African-American population who suffer greater death and disability from heart disease, stroke, and renal failure than whites. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Blood Pressure
- What is being tested?
- Peer Coach Phone Calls, Health Educator Visits and written materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Jan 2011
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American
- Uncontrolled Hypertension
- at least 3 practice visits in the past 2 years
- One lipid panel since 2005
Who cannot join
- No recent lipid panel
- Kept less than 60% of primary care visits in the prior 2 years
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Edward S. Cooper Practice of General Internal Medicine
Philadelphia, Pennsylvania, 19104
PennCare Internal Medicine Associates
Philadelphia, Pennsylvania, 19104
About this study
Official title: Peer and Health Educator Support for Cardiovascular Health in African-American Primary Care Patients
Project Overview:
Poor hypertension control has dire consequences for the African-American population who suffer greater death and disability from heart disease, stroke, and renal failure than whites. To reduce these health disparities it is critical to promote of a healthy lifestyle in regard to diet, exercise, adherence to medications, as well as other behaviors. However, physicians usually fail to address lifestyle behaviors in the context of the harried patient visit. Therefore, the investigators hypothesized that the investigators could reduce cardiovascular risk by providing additional support to persons with poorly controlled hypertension through phone calls from trained peer patients and visits to an office support staff member.
Read more
Study Design:
A single-blind, randomized, controlled trial in 280 African-American primary care patients aged 40-75 with poorly controlled hypertension (HTN). The intervention group receives a practice-based team intervention that combines peer coach with office staff (i.e., medical assistant or licensed practice nurse) visits to address lifestyle challenges. Both intervention and control groups receive informational materials and healthy soul food recipes from the American Heart Association. The 6 month intervention alternates monthly phone calls from peer coaches about lifestyle behavioral changes with office-based visits with the support staff member during which patients review and discuss low literacy slide shows about healthy behaviors as well as examine their personal cardiovascular risk profile.
- Conditions
- Cardiovascular Diseases, Blood Pressure
- Being tested
- Peer Coach Phone Calls, Health Educator Visits, written materials
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Coach Phone CallsBehavioural
Subjects will receive 3 phone calls from a trained peer coach over 6 months.
Health Educator VisitsBehavioural
Subjects will meet 2 times with a trained health educator in the practice
written materialsOther
Subjects will receive written material and brochures and a cookbook from the American Heart Association addressing healthy lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | Not described Receives: Behavioral: Peer Coach Phone Calls; Behavioral: Health Educator Visits; Other: written materials |
| Control | Active comparator | Not described Receives: Other: written materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Greater reduction in CHD risk in case group vs. control
Measured: 6 months
Secondary outcomes (1)
5mm reduction in systolic blood pressure in case group
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 posted29 Jul 2009 (estimated)
- Study startMay 2008
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Pfizer
- Responsible party
- Sponsor
- Investigators
- Mark G Weiner, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948714
- Sponsor's protocol ID
- 808214
- Status last verified
- Jul 2017
- First submitted
- 28 Jul 2009
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Turner BJ, Hollenbeak CS, Liang Y, Pandit K, Joseph S, Weiner MG. A randomized trial of peer coach and office staff support to reduce coronary heart disease risk in African-Americans with uncontrolled hypertension. J Gen Intern Med. 2012 Oct;27(10):1258-64. doi: 10.1007/s11606-012-2095-4. Epub 2012 May 9.
PubMed 22570108
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer and Health Educator Support for Cardiovascular Health in African-American Primary Care Patients
- ClinicalTrials.gov ID
- NCT00948714
- Acronym / sponsor ID
- 808214
- Conditions
- Cardiovascular Diseases, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Pfizer
- Study start
- May 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 Jul 2009 (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.
Project Overview:
Poor hypertension control has dire consequences for the African-American population who suffer greater death and disability from heart disease, stroke, and renal failure than whites. To reduce these health disparities it is critical to promote of a healthy lifestyle in regard to diet, exercise, adherence to medications, as well as other behaviors. However, physicians usually fail to address lifestyle behaviors in the context of the harried patient visit. Therefore, the investigators hypothesized that the investigators could reduce cardiovascular risk by providing additional support to persons with poorly controlled hypertension through phone calls from trained peer patients and visits to an office support staff member.
Study Design:
A single-blind, randomized, controlled trial in 280 African-American primary care patients aged 40-75 with poorly controlled hypertension (HTN). The intervention group receives a practice-based team intervention that combines peer coach with office staff (i.e., medical assistant or licensed practice nurse) visits to address lifestyle challenges. Both intervention and control groups receive informational materials and healthy soul food recipes from the American Heart Association. The 6 month intervention alternates monthly phone calls from peer coaches about lifestyle behavioral changes with office-based visits with the support staff member during which patients review and discuss low literacy slide shows about healthy behaviors as well as examine their personal cardiovascular risk profile.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Behavioral: Peer Coach Phone Calls, Behavioral: Health Educator Visits, Other: written materials |
| Control | Active comparator | Other: written materials |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- African American
- Uncontrolled Hypertension
- at least 3 practice visits in the past 2 years
- One lipid panel since 2005
Key exclusion criteria (2 listed)
- No recent lipid panel
- Kept less than 60% of primary care visits in the prior 2 years
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 |
|---|---|---|
| Peer Coach Phone CallsSubjects will receive 3 phone calls from a trained peer coach over 6 months. | Behavioural | Case |
| Health Educator VisitsSubjects will meet 2 times with a trained health educator in the practice | Behavioural | Case |
| written materialsSubjects will receive written material and brochures and a cookbook from the American Heart Association addressing healthy lifestyle | Other | Case, Control |
Primary outcome
Greater reduction in CHD risk in case group vs. control
Time frame: 6 months
1 secondary outcome
5mm reduction in systolic blood pressure in case group
Time frame: 6 months
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 21 Jul 2017.
- Derived from this study: PubMed 22570108Turner BJ, Hollenbeak CS, Liang Y, Pandit K, Joseph S, Weiner MG. A randomized trial of peer coach and office staff support to reduce coronary heart disease risk in African-Americans with uncontrolled hypertension. J Gen Intern Med. 2012 Oct;27(10):1258-64. doi: 10.1007/s11606-012-2095-4. Epub 2012 May 9.
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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.
Mark G Weiner, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Coach Phone Calls, Health Educator Visits and written materials in people with Cardiovascular Diseases and Blood Pressure, run by University of Pennsylvania at 2 sites 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 4 inclusion and 2 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Greater reduction in CHD risk in case group vs. control (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00948714, which also lists 1 linked publication.
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 21 Jul 2017.