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NCT01070056 · ClinicalTrials.gov registry record · Phase 3
Practice-based Trial of Blood Pressure Control in African Americans
A Phase 3 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 194
- Enrollment target
NCT01070056 is a Phase 3 study that has completed, run by NYU Langone Health. The registered enrollment target is 194 participants.
The verdict
NCT01070056, a Phase 3 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 194 participants
- Enrollment target
Study Summary
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
Interventions
- BEHAVIORAL Usual Care
- BEHAVIORAL Therapeutic Lifestyle Changes (MINT-TLC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01070056
The ClinicalTrials.gov registry entry for NCT01070056 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT01070056 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01070056 about?
NCT01070056 is a clinical study titled "Practice-based Trial of Blood Pressure Control in African Americans". 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) red...
What is the current status of trial NCT01070056?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2010-02. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01070056?
The interventions under investigation include: Usual Care (BEHAVIORAL), Therapeutic Lifestyle Changes (MINT-TLC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01070056?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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