HypertensionNCT07703423
Optimizing Care For Management Of Hard To Control Hypertension In Low-Income Patients Across Family Health Centers In New York City
A study testing Multilevel Hypertension Care Model in people with Hypertension, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will develop and evaluate a multilevel implementation strategy to improve management of hard-to-control hypertension among low-income adults receiving care at the Family Health Centers at NYU Langone Health, a network of federally qualified health centers (FQHCs) in New York City. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Multilevel Hypertension Care Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will develop and evaluate a multilevel implementation strategy to improve management of hard-to-control hypertension among low-income adults receiving care at the Family Health Centers at NYU Langone Health, a network of federally qualified health centers (FQHCs) in New York City.
Using a hybrid mixed-methods implementation science design, the study will be conducted across 9 primary care locations over three phases: a pre-implementation phase to identify contextual barriers using the Consolidated Framework for Implementation Research (CFIR); an implementation phase to deploy and evaluate a multilevel care model; and a post-implementation phase to develop a pragmatic toolkit for scale-up.
- Conditions
- Hypertension
- Being tested
- Multilevel Hypertension Care Model
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel Hypertension Care ModelBehavioural
The intervention is delivered through the existing My Virtual Care (MVC) Epic-integrated team-based virtual high-risk clinic infrastructure and is adapted specifically for patients with hard-to-control hypertension. It is organized across four levels:
- Patient-Level Strategies (Individual delivery, remote and in-person)
- Provider and Health System-Level Strategies (EHR-embedded)
- Community-Level Strategies (Individual, CHW-navigated)
- Implementation Support
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants who attend FHCs assigned to receive the multilevel care model intervention. Receives: Behavioral: Multilevel Hypertension Care Model |
| Control | No intervention | Participants who attend FHCs that were not assigned to receive the multilevel care model intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure (SBP)
Measured: Baseline, Month 6
Secondary outcomes (8)
Time to Treatment Intensification
Defined as the number of days from the index encounter meeting criteria for hard-to-control hypertension to the first prescription of a new antihypertensive class or dose increase of an existing blood pressure medication that was not present at the index encounter.
Measured: Up to Month 12
Blood Pressure Control - Guideline Metric
Defined as the proportion of patients achieving controlled blood pressure at the guideline-relevant threshold of <130/80 mmHg.
Measured: Month 6, Month 12
Blood Pressure Control - Performance Metric
Defined as the proportion of patients achieving controlled blood pressure at the performance metric threshold of <140/90 mmHg
Measured: Month 6, Month 12
Use of Mineralocorticoid Antagonists
Proportion of patients who report use of mineralocorticoid antagonists.
Measured: Up to Month 12
Use of Single-Pill Combinations
Proportion of patients who report use of single-pill combinations.
Measured: Up to Month 12
Use of Long-acting Thiazide Diuretics
Proportion of patients who report use of long-acting thiazide diuretics.
Measured: Up to Month 12
Time to Completed Follow-up Visit
Time to completed follow-up visit (remote or in person) after an encounter with hard-to-control hypertension as a marker of care process efficiency.
Measured: Up to Month 12
Change in Life's Essential 8 Components Score
Assessment of cardiovascular health using eight key components-four lifestyle behaviors and four health factors. Each component is scored from 0 to 100; the total score is the average of the components and ranges from 0-100; higher scores indicate greater cardiovascular health.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startFeb 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 628 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Olugbenga Ogedegbe, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703423
- Sponsor's protocol ID
- 26-00578
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded study data may be shared with other researchers for future research related to hypertension management, implementation science, health equity, cardiovascular outcomes, and health-related social needs in safety-net settings, for participants who consent to optional future data storage and use. Shared data will not include direct identifiers. The link between the code and participant identity will remain with the Principal Investigator at NYU Langone Health and will not be shared with outside researchers. Such data may become available after completion of the study and publication of the primary study findings. Data may be retained indefinitely by NYU Langone Health, subject to participant consent for optional future data storage and use, institutional policies, sponsor requirements, IRB requirements, and applicable confidentiality protections. Participants may withdraw permission for future use, after which stored data will not be used for new analyses.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care For Management Of Hard To Control Hypertension In Low-Income Patients Across Family Health Centers In New York City
- ClinicalTrials.gov ID
- NCT07703423
- Acronym / sponsor ID
- 26-00578
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 628 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will develop and evaluate a multilevel implementation strategy to improve management of hard-to-control hypertension among low-income adults receiving care at the Family Health Centers at NYU Langone Health, a network of federally qualified health centers (FQHCs) in New York City.
Using a hybrid mixed-methods implementation science design, the study will be conducted across 9 primary care locations over three phases: a pre-implementation phase to identify contextual barriers using the Consolidated Framework for Implementation Research (CFIR); an implementation phase to deploy and evaluate a multilevel care model; and a post-implementation phase to develop a pragmatic toolkit for scale-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Multilevel Hypertension Care ModelParticipants who attend FHCs assigned to receive the multilevel care model intervention. |
| Control | No intervention | –Participants who attend FHCs that were not assigned to receive the multilevel care model intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multilevel Hypertension Care ModelThe intervention is delivered through the existing My Virtual Care (MVC) Epic-integrated team-based virtual high-risk clinic infrastructure and is adapted specifically for patients with hard-to-control hypertension. It is organized across four levels: 1. Patient-Level Strategies (Individual delivery, remote and in-person) 2. Provider and Health System-Level Strategies (EHR-embedded) 3. Community-Level Strategies (Individual, CHW-navigated) 4. Implementation Support | Behavioural | Intervention |
Primary outcome
Change in Systolic Blood Pressure (SBP)
Time frame: Baseline, Month 6
8 secondary outcomes
Time to Treatment Intensification
Time frame: Up to Month 12
Blood Pressure Control - Guideline Metric
Time frame: Month 6, Month 12
Blood Pressure Control - Performance Metric
Time frame: Month 6, Month 12
Use of Mineralocorticoid Antagonists
Time frame: Up to Month 12
Use of Single-Pill Combinations
Time frame: Up to Month 12
Use of Long-acting Thiazide Diuretics
Time frame: Up to Month 12
Time to Completed Follow-up Visit
Time frame: Up to Month 12
Change in Life's Essential 8 Components Score
Time frame: Baseline, Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. Coded study data may be shared with other researchers for future research related to hypertension management, implementation science, health equity, cardiovascular outcomes, and health-related social needs in safety-net settings, for participants who consent to optional future data storage and use. Shared data will not include direct identifiers. The link between the code and participant identity will remain with the Principal Investigator at NYU Langone Health and will not be shared with outside researchers. Such data may become available after completion of the study and publication of the primary study findings. Data may be retained indefinitely by NYU Langone Health, subject to participant consent for optional future data storage and use, institutional policies, sponsor requirements, IRB requirements, and applicable confidentiality protections. Participants may withdraw permission for future use, after which stored data will not be used for new analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olugbenga Ogedegbe, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilevel Hypertension Care Model in people with Hypertension, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olugbenga Ogedegbe, MD (646-501-3435, Olugbenga.ogedegbe@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (SBP) (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.