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Practice Facilitation for High Blood Pressure

Phase 4
Recruiting
Led By Antoinette Schoenthaler, EdD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be age 18 years or older
Have uncontrolled HTN documented in the electronic health record (EHR) on at least two visits in the past year (defined as an average BP ≥ 140/90 mmHg)
Must not have
Refuse to participate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial evaluates a method where a team helps healthcare providers improve how Latinx patients with high blood pressure take their medication and manage their health. Health coaches work with these patients to teach them about their medication, help them plan their care, and monitor their progress to achieve better health outcomes.

Who is the study for?
This trial is for adults over 18 who identify as Latino, speak English or Spanish, have high blood pressure not controlled by medication (less than 80% adherence), and are treated in a safety-net primary care practice. They must interact with healthcare staff regularly but can't join if they're in another hypertension study, have significant mental health or substance abuse issues, plan to leave their current clinic soon, or can't follow the study protocol.
What is being tested?
The trial is testing 'ALTA', an intervention facilitated by practice staff aimed at improving how well patients stick to their high blood pressure treatment plans. The main goal is to see if this approach helps patients better follow their treatment regimen and improve clinical measures like blood pressure after one year.
What are the potential side effects?
Since ALTA involves implementing a new practice facilitation method rather than a drug, traditional side effects aren't expected. However, there may be indirect effects related to changes in medication adherence or adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
My blood pressure has been high (≥ 140/90 mmHg) on two visits in the past year.
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I am fluent in either English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not want to participate in the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Level of implementation fidelity
Secondary study objectives
Blood Pressure (BP) control
Medication adherence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Practice FaciliationExperimental Treatment1 Intervention
Will be supported by a practice facilitator
Group II: Usual CareActive Control1 Intervention
Using a stepped wedge design, all practice sites begin as part of the Usual Care (UC) control condition and will receive standard hypertension management that is part of the current clinic procedure. No practice facilitation will occur at this time.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for high blood pressure include diuretics, which help the kidneys remove excess sodium and water from the body, reducing blood volume; ACE inhibitors and ARBs, which relax blood vessels by blocking the formation or action of angiotensin, a chemical that narrows blood vessels; calcium channel blockers, which prevent calcium from entering the cells of the heart and blood vessel walls, leading to more relaxed vessels; and beta-blockers, which reduce heart rate and the heart's output of blood. Understanding these mechanisms is crucial for patients as it helps them comprehend how their medications work to lower blood pressure, the importance of adherence, and the potential side effects, thereby improving their engagement and outcomes in treatment plans facilitated by healthcare practices.
Criteria for an informative trial of left ventricular hypertrophy regression.Research and Global Health Emergencies: On the Essential Role of Best Practice.How can we improve adherence?

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,411 Previous Clinical Trials
854,972 Total Patients Enrolled
Antoinette Schoenthaler, EdDPrincipal InvestigatorNYUMC Langone
5 Previous Clinical Trials
919 Total Patients Enrolled

Media Library

ALTA Clinical Trial Eligibility Overview. Trial Name: NCT03713515 — Phase 4
High Blood Pressure Research Study Groups: Usual Care, Practice Faciliation
High Blood Pressure Clinical Trial 2023: ALTA Highlights & Side Effects. Trial Name: NCT03713515 — Phase 4
ALTA 2023 Treatment Timeline for Medical Study. Trial Name: NCT03713515 — Phase 4
~260 spots leftby Jun 2027