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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test whether practice facilitation can help improve the fidelity of an intervention and clinical measures.

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.Check my eligibility
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.See study design
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.
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My blood pressure has been high (≥ 140/90 mmHg) on two visits in the past year.
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I have not consistently taken my blood pressure medication as prescribed.
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I am fluent in either English or Spanish.

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

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

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.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,026 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this research project younger than twenty years old?

"This trial is seeking volunteers who are of legal age and under 90 years old."

Answered by AI

Has the Federal Drug Administration authorized ALTA for utilization?

"Since ALTA has already been approved, there is a high degree of confidence in its safety; thus it earned a score of 3."

Answered by AI

Is participation in this experiment available to me?

"This research initiative is seeking 700 individuals with hypertension aged 18-90. The primary prerequisites for eligibility are: participants must be prescribed one or more antihypertensive medications and have exhibited <80% adherence to the prescriptions in the last year, as per pharmacy records obtained from their healthcare provider's electronic health record system; they must also exceed the age of majority."

Answered by AI

Are individuals being enlisted for the experiment at this time?

"Affirmative. Clinicaltrials.gov affirms that this clinical trial, first uploaded on December 1st 2020, is actively looking for participants. Approximately 700 people must be enrolled from a single healthcare facility to complete the study."

Answered by AI

Is there a cap on the number of participants in this medical research project?

"Indeed, clinicaltrials.gov verifies that this research study is still recruiting participants for participation. The trial was posted on December 1st 2020 and recently modified on November 8th 2022; 700 patients are required from one medical site to complete the experiment."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
NYUMC Langone
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
~33 spots leftby Jul 2024