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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 belowSelect...
I am 18 years old or older.
Select...
My blood pressure has been high (≥ 140/90 mmHg) on two visits in the past year.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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?
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?
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My blood pressure has been high (≥ 140/90 mmHg) on two visits in the past year.I have not consistently taken my blood pressure medication as prescribed.I am fluent in either English or Spanish.You plan to stop getting medical care at your current doctor's office within the next year.I do not want to participate in the trial.I am able to follow all study requirements.You have already taken part in other clinical trials related to high blood pressure.You have serious mental health issues or a history of drug or alcohol problems noted in your medical records.You are currently getting medical care at a safety-net primary care clinic.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Practice Faciliation
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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