Practice-based Trial of Blood Pressure Control in African Americans

Completed · Phase 3

Conditions studied: Hypertension, Physical Activity, Diet, Medication Adherence

In brief

Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) on blood pressure (BP) reduction, their effectiveness remains untested in primary care practices, especially among minority patients who share a greater burden of HTN-related outcomes including chronic kidney disease, stroke and heart failure. This randomized controlled trial offers a unique opportunity to address this gap in the literature. Among 200 hypertensive African-Americans who receive care in community- based primary care practices, we will test the effectiveness of a culturally-tailored comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) vs. Usual Care (UC). MINT-TLC is designed to help patients make appropriate TLC and develop skills to maintain these changes long-term. Patients in the MINT-TLC group will attend weekly group classes focused on TLC for 12 weeks (intensive phase); followed by individual motivational interviewing (MINT) sessions for 3 months (maintenance phase). Trained research personnel will deliver MINT-TLC with appropriate treatment fidelity procedures. Patients in the UC condition will receive a single individual counseling session on TLC and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic blood pressure from baseline to 6 months. Secondary outcomes are levels of targeted therapeutic lifestyle behaviors; and proportion of patients with adequate blood pressure control at 6 months

Key facts

Study ID

NCT01070056

Run by

NYU Langone Health

People needed

194

Starts

2010-02-01

Expected to finish

2012-07-01

Last updated by the study team

2013-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Receiving care within the NYU Ambulatory Care Network for at least one year.
• Patient must have uncontrolled HTN defined as an average SBP≥140 mmHg or DBP≥90 mmHg (SBP≥130 mmHg or DBP≥80 mmHg for patients with diabetes or chronic kidney disease) on at least two previous visits in the past year
• English speaking
• Self-identify as Black, or African American;
• Permission by patient's physician to participate in the study.
• CARE-DIAG score < 6 (participants age 60 and older only)

You may not qualify if…

• Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks including attend intervention classes if he/she were to be randomized to the intervention group).
• Participation in other clinical trials.
• Diagnosis of cognitive dysfunction or significant psychiatric comorbidity (as indicated in medical record).
• Blood pressure reading ≥ 180/110 at initial screening/baseline visit
• Pregnant

Where it is running

• Woodhull Medical & Mental Health Center — Brooklyn, New York, United States
• Governeur Hospital — New York, New York, United States
• Bellevue Hospital Center — New York, New York, United States
• Lincoln Hospital and Harlem Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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