New care model aims to tackle stubborn high blood pressure in underserved communities

NCT ID NCT07703423

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests a multilevel care model designed to help low-income adults with hard-to-control hypertension. The model combines patient education, electronic health record alerts for providers, and support from community health workers. Researchers will measure changes in blood pressure and how quickly treatment is adjusted. The goal is to find a practical way to improve blood pressure control in community health centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a multilevel care model including patient education, provider alerts, and community health worker support
What this could lead to
If successful, this approach could provide a practical blueprint for improving blood pressure control in underserved communities.
What could go wrong
This is a behavioral intervention study, not a drug trial, so results may vary by site and patient engagement. The effect on blood pressure may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 628 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patient aged 18 years or older receiving primary care at one of the nine participating Family Health Centers at NYU Langone Health locations in Brooklyn, New York City. * Active primary care patient at a participating Family Health Centers location, defined as having at least one documented primary care encounter in the Epic electronic health record within the 24 months prior to the index encounter. * Documented hard-to-control hypertension, defined as blood pressure ≥140/90 mmHg based on clinic blood pressure values and, where available, validated home blood pressure readings documented in the electronic health record, in a patient already receiving two or more antihypertensive agents. * Current prescription of two or more antihypertensive medications documented in the Epic medication list at the index encounter. * Willingness and ability to participate in study procedures, including home blood pressure telemonitoring, telehealth-based medication review by the nurse case manager via telephone or video visit, and automated SMS pre-visit activation messages. Patients with digital literacy challenges, difficulty transmitting home readings, or other operational barriers will receive CHW support to facilitate participation, consistent with the CHW navigation model embedded in the multilevel care model. * Provision of informed consent or, where applicable under the IRB-approved protocol, a waiver of informed consent for EHR-based data extraction and registry-based outcome ascertainment. Exclusion Criteria: * Age under 18 years at the time of the index encounter. * No active primary care relationship at a participating Family Health Centers location, defined as fewer than one completed primary care encounter in the Epic EHR in the 12 months prior to the index encounter. * Blood pressure at the index encounter does not meet the study definition of hard-to-control hypertension (BP ≥140/90 mmHg on two or more antihypertensive medications). * Confirmed secondary cause of hypertension (examples include kidney disease, renovascular disease, primary aldosteronism, obstructive sleep apnea, thyroid disorders, and medication- or substance-induced hypertension, such as that caused by NSAIDs, steroids, oral contraceptives, or stimulants) where treatment of the underlying condition is the primary indicated management. * Current enrollment in hospice or palliative care. * End-stage renal disease requiring dialysis at the time of the index encounter. * Documented cognitive impairment or dementia that would preclude participation in home blood pressure telemonitoring or telehealth visits, as determined by clinical documentation in the EHR. * Known pregnancy at the time of the index encounter. Pregnant persons are not included in this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10016, United States

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