HypertensionNCT01425515
Improving Care for Patients With High Blood Pressure
A study testing Complex quality improvement intervention in people with Hypertension and Cardiovascular Disease Risk, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The investigators are conducting a single group intervention study to improve blood pressure control and reduce racial and literacy related disparities among people with hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Disease Risk
- What is being tested?
- Complex quality improvement intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 535 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Oct 2014
- 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
- Men and women who meet the following inclusion criteria will be eligible for study participation:
- 18 years or older,
- Able and willing to give informed consent,
- A current patient of 1 of the 5 participating practices,
- Have a current diagnosis of hypertension by their primary care physician or have 3 documented blood pressures above 150/90,
- Their most recent systolic blood pressure was greater than or equal to 150 at their most recent clinic visit,
- Receive physician approval to participate in the study.
- Anyone enrolled in the High Blood Pressure study is eligible to participate in the genomics component of the project.
Who cannot join
- non-English speaking,
- current treatment of psychosis,
- diagnosed with advanced dementia as determined by the clinician,
- current substance abuse,
- lack of phone access,
- history of malignancy, other than non-melanoma skin cancer, that has not been in remission or cured surgically for > 5 years,
- estimated creatinine clearance less than 30 ml/min (because hypertension management becomes more complicated at this point),
- are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kinston Enterprise Center - Study Office
Kinston, North Carolina, 28501
About this study
Official title: Heart Healthy Lenoir: Improving Care for Patients With High Blood Pressure
The investigators are conducting a single group intervention study to improve blood pressure control and reduce racial and literacy related disparities among people with hypertension. The intervention includes providing patients with home blood pressure monitors, administering phone-coaching to participants, and improving hypertension care at the participating practices from which patients are enrolled. The investigators will follow the patients for 2 years to determine if blood pressure control improves. In addition, the project will explore genetic factors associated with cardiovascular disease risk and treatment success.
- Conditions
- Hypertension, Cardiovascular Disease Risk
- Being tested
- Complex quality improvement intervention
- Keywords
- hypertension, genomics
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex quality improvement interventionBehavioural
We are implementing a complex quality improvement intervention that includes changes in practice processes to enhance hypertension care, provision of home blood pressure monitors to patients, and telephone coaching around hypertension self-management.
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
We will measures blood pressure at enrollment and then every 6 months for 24 months.
Measured: 2 years
Secondary outcomes (3)
Blood lipids
We will measure blood lipids including total cholesterol and HDL over the course of the study to calculate overall cardiovascular risk.
Measured: 2 years
General Cardiovascular Disease Risk
We will measure variables (blood pressure, cholesterol, aspirin use, smoking status, and diabetes status) to calculate general cardiovascular disease risk which includes (coronary death, myocardial infarction, coronary insufficiency, angina, ischemic stroke, hemorrhagic stroke, transient ischemic attack, peripheral artery disease, heart failure). (D'Agostino, 2008)
Measured: 2 years
Genomic predictors of blood pressure change
A systems approach to developing genomic models integrating clinical and genomic data.
Measured: 6-, 12-, 18, and 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jacquie Halladay, MD, MPH, University of North Carolina, Chapel Hill
- Investigators
- Jacqueline Halladay, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425515
- Sponsor's protocol ID
- 10-0395
- Other IDs
- P50HL105184
- Status last verified
- Nov 2014
- First submitted
- 26 Aug 2011
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
PubMed 18212285Cummings DM, Adams A, Halladay J, Hinderliter A, Donahue KE, Cene CW, Li Q, Miller C, Garcia B, Tillman J, Little E, DeWalt D. Race-Specific Patterns of Treatment Intensification Among Hypertensive Patients Using Home Blood Pressure Monitoring: Analysis Using Defined Daily Doses in the Heart Healthy Lenoir Study. Ann Pharmacother. 2019 Apr;53(4):333-340. doi: 10.1177/1060028018806001. Epub 2018 Oct 3.
PubMed 30282468Chatterjee A, Daftary G, Gatison L, Gillman MW. Lessons Learned From a Partnership to Evaluate a School Food Program. Prog Community Health Partnersh. 2016;10(4):577-584. doi: 10.1353/cpr.2016.0066.
PubMed 28569683Cummings DM, Wu JR, Cene C, Halladay J, Donahue KE, Hinderliter A, Miller C, Garcia B, Penn D, Tillman J, DeWalt D. Perceived Social Standing, Medication Nonadherence, and Systolic Blood Pressure in the Rural South. J Rural Health. 2016 Spring;32(2):156-63. doi: 10.1111/jrh.12138. Epub 2015 Sep 3.
PubMed 26334761Halladay JR, Donahue KE, Hinderliter AL, Cummings DM, Cene CW, Miller CL, Garcia BA, Tillman J, DeWalt D; Heart Healthy Lenoir Research Team. The Heart Healthy Lenoir project--an intervention to reduce disparities in hypertension control: study protocol. BMC Health Serv Res. 2013 Oct 25;13:441. doi: 10.1186/1472-6963-13-441.
PubMed 24156629
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Healthy Lenoir: Improving Care for Patients With High Blood Pressure
- ClinicalTrials.gov ID
- NCT01425515
- Acronym / sponsor ID
- 10-0395
- Conditions
- Hypertension, Cardiovascular Disease Risk
- Keywords
- hypertension, genomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Aug 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 are conducting a single group intervention study to improve blood pressure control and reduce racial and literacy related disparities among people with hypertension. The intervention includes providing patients with home blood pressure monitors, administering phone-coaching to participants, and improving hypertension care at the participating practices from which patients are enrolled. The investigators will follow the patients for 2 years to determine if blood pressure control improves. In addition, the project will explore genetic factors associated with cardiovascular disease risk and treatment success.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women who meet the following inclusion criteria will be eligible for study participation:
- 18 years or older,
- Able and willing to give informed consent,
- A current patient of 1 of the 5 participating practices,
- Have a current diagnosis of hypertension by their primary care physician or have 3 documented blood pressures above 150/90,
Key exclusion criteria (8 listed)
- non-English speaking,
- current treatment of psychosis,
- diagnosed with advanced dementia as determined by the clinician,
- current substance abuse,
- lack of phone access,
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 |
|---|---|---|
| Complex quality improvement interventionWe are implementing a complex quality improvement intervention that includes changes in practice processes to enhance hypertension care, provision of home blood pressure monitors to patients, and telephone coaching around hypertension self-management. | Behavioural | – |
Primary outcome
systolic blood pressure
Time frame: 2 years
We will measures blood pressure at enrollment and then every 6 months for 24 months.
3 secondary outcomes
Blood lipids
Time frame: 2 years
General Cardiovascular Disease Risk
Time frame: 2 years
Genomic predictors of blood pressure change
Time frame: 6-, 12-, 18, and 24-month follow-up
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 19 Nov 2014.
- Background: PubMed 18212285D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
- Derived from this study: PubMed 30282468Cummings DM, Adams A, Halladay J, Hinderliter A, Donahue KE, Cene CW, Li Q, Miller C, Garcia B, Tillman J, Little E, DeWalt D. Race-Specific Patterns of Treatment Intensification Among Hypertensive Patients Using Home Blood Pressure Monitoring: Analysis Using Defined Daily Doses in the Heart Healthy Lenoir Study. Ann Pharmacother. 2019 Apr;53(4):333-340. doi: 10.1177/1060028018806001. Epub 2018 Oct 3.
- Derived from this study: PubMed 28569683Chatterjee A, Daftary G, Gatison L, Gillman MW. Lessons Learned From a Partnership to Evaluate a School Food Program. Prog Community Health Partnersh. 2016;10(4):577-584. doi: 10.1353/cpr.2016.0066.
- Derived from this study: PubMed 26334761Cummings DM, Wu JR, Cene C, Halladay J, Donahue KE, Hinderliter A, Miller C, Garcia B, Penn D, Tillman J, DeWalt D. Perceived Social Standing, Medication Nonadherence, and Systolic Blood Pressure in the Rural South. J Rural Health. 2016 Spring;32(2):156-63. doi: 10.1111/jrh.12138. Epub 2015 Sep 3.
- Derived from this study: PubMed 24156629Halladay JR, Donahue KE, Hinderliter AL, Cummings DM, Cene CW, Miller CL, Garcia BA, Tillman J, DeWalt D; Heart Healthy Lenoir Research Team. The Heart Healthy Lenoir project--an intervention to reduce disparities in hypertension control: study protocol. BMC Health Serv Res. 2013 Oct 25;13:441. doi: 10.1186/1472-6963-13-441.
- Summary information about the Heart Healthy Lenoir ProjectLink 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.
Jacqueline Halladay, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex quality improvement intervention in people with Hypertension and Cardiovascular Disease Risk, run by University of North Carolina, Chapel Hill 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 8 inclusion and 8 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 19 Nov 2014. 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.
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?
systolic blood pressure (time frame: 2 years). 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 NCT01425515, which also lists 5 linked publications.
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 19 Nov 2014.