Hypertension (HTN)NCT05208450
Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks
A study testing Practice support And Community Engagement (PACE) in people with Hypertension (HTN), run by NYU Langone Health at 1 site in United States.
Trial summary
To use practice facilitation (PF) + community health worker (CHW) facilitation as a practical and sustainable implementation strategy to support the implementation and evaluation of three multi-level evidence-based interventions [nurse case management (NCM), remote blood pressure monitoring (RBPM), and social… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- Practice support And Community Engagement (PACE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2025to 31 Aug 2027
- 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
- Patients are eligible if he/she:
- identifies as Black (through EHR code or self-report)
- is 18+ years of age
- has a diagnosis of HTN (identified by ICD-10 codes for HTN)
- prescribed an antihypertensive medication(s)
- has a clinic BP > 130/80 mmHg
Who cannot join
- Patients will be ineligible for the study if they:
- are deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks)
- participate in other hypertension-related clinical trials
- have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
- plan to discontinue care at the site within the next 12 months; or
- are pregnant or planning to become pregnant in the next 12 months
Show all 14Show fewer
- IMPLEMENTATION EVALUATION
- NYULH Primary care provider (MD/DO, NP), Clinical Director, Site Administrator, Medical Assistant, or administrative staff employed at the participating practices and interacts with at least five patients with a diagnosis of hypertension; or
- NYULH Nurse case manager within centralized service; or
- Staff and leadership of community- and faith-based organizations serving the Black community; or
- NYULH Organizational leadership; or
- NYULH Project Staff: Community Health Workers/CHW Supervisor/Practice Facilitators; and
- Able and willing to provide consent
- 1. Refusal to participate
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
To use practice facilitation (PF) + community health worker (CHW) facilitation as a practical and sustainable implementation strategy to support the implementation and evaluation of three multi-level evidence-based interventions [nurse case management (NCM), remote blood pressure monitoring (RBPM), and social determinants of health (SDOH) support] delivered as an integrated community-clinic linkage model [Practice support And Community Engagement (PACE) to address patient-, physician-, health system-, and community-level barriers to hypertension (HTN) control in Blacks across 25 primary practices within NYU Langone Health in New York City (NYC) and, in partnership with an established Community-Clinic-Academic Advisory Board and HealthFirst (NYC's largest Medicaid payer).
The goal for the UH3 Implementation Phase (Years 4-7, Intervention) is to evaluate a stepped-wedge cluster RCT of 25 primary care practices in Black patients with uncontrolled hypertension (HTN)
- Conditions
- Hypertension (HTN)
- Being tested
- Practice support And Community Engagement (PACE)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice support And Community Engagement (PACE)Other
A practical and sustainable implementation strategy, referred to as Practice Facilitation And social deTerminants of health support utilizing CHWs (PATCH), to support the implementation and evaluation of three multi-level evidence-based interventions: [nurse case management (NCM) + remote blood pressure monitoring (RBPM) + social determinants of health (SDOH) support] delivered as an integrated community-clinic linkage model [Practice support And Community Engagement (PACE)]
| Study group | Role | What they receive |
|---|---|---|
| Usual care (UC) Group | No intervention | The study design is a randomized stepped wedge cluster trial whereby all clusters (practice sites) begin as part of the Usual Care (UC) control condition. Clusters are then randomly assigned to cross over at different times with all clusters eventually receiving PACE. The study will involve each site starting with the UC, followed by a period of 3 months during which practice facilitators will train NCMs and CHWs, and finally followed by the PACE intervention for 12 months with a 6-month follow-up for outcome assessment. During the UC Period, patients at the sites will receive standard HTN care and standard printed HTN treatment guidelines. Immediately following this period, prior to implementation of PACE, we will conduct a practice capacity assessment at each site for 3 months. This period is then followed by the implementation of PACE. |
| Intervention Group | Experimental | Thus, each cluster will belong successively to the control group and the intervention group. During the control period (UC) patients at the sites will receive standard HTN care delivered by their primary care providers and standard printed HTN treatment guidelines. This period is then followed by the implementation of PACE. Clusters are randomly assigned to cross over at different times with all clusters eventually receiving PACE. During the PACE implementation period, which will last 12 months, practice facilitators will work with each site to implement the components of PACE. Receives: Other: Practice support And Community Engagement (PACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Nurses who adopt the PACE intervention
Defined at the Nurse-level who adopt both electronic health record (EHR) remote BP monitoring (RBPM) and social determinants of health (SDOH) Smartsets
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start12 Jun 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension (HTN)Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gbenga Ogedegbe, MD, MPH, Principal investigator, NYU Langone HealthNadia Islam, PhD, Principal investigator, NYU Langone HealthAntoinette Schoenthaler, EdD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208450
- Sponsor's protocol ID
- 20-01114
- Status last verified
- May 2026
- First submitted
- 11 Jan 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Publications
Gyamfi J, Cooper C, Barber A, Onakomaiya D, Lee WY, Zanowiak J, Mansu M, Diaz L, Thompson L, Abrams R, Schoenthaler A, Islam N, Ogedegbe G. Needs assessment and planning for a clinic-community-based implementation program for hypertension control among blacks in New York City: a protocol paper. Implement Sci Commun. 2022 Sep 6;3(1):96. doi: 10.1186/s43058-022-00340-z.
PubMed 36068611
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks
- ClinicalTrials.gov ID
- NCT05208450
- Acronym / sponsor ID
- 20-01114
- Conditions
- Hypertension (HTN)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Jan 2022 (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.
To use practice facilitation (PF) + community health worker (CHW) facilitation as a practical and sustainable implementation strategy to support the implementation and evaluation of three multi-level evidence-based interventions [nurse case management (NCM), remote blood pressure monitoring (RBPM), and social determinants of health (SDOH) support] delivered as an integrated community-clinic linkage model [Practice support And Community Engagement (PACE) to address patient-, physician-, health system-, and community-level barriers to hypertension (HTN) control in Blacks across 25 primary practices within NYU Langone Health in New York City (NYC) and, in partnership with an established Community-Clinic-Academic Advisory Board and HealthFirst (NYC's largest Medicaid payer).
The goal for the UH3 Implementation Phase (Years 4-7, Intervention) is to evaluate a stepped-wedge cluster RCT of 25 primary care practices in Black patients with uncontrolled hypertension (HTN)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster RCT
| Arm | Type | Receives |
|---|---|---|
| Usual care (UC) Group | No intervention | –The study design is a randomized stepped wedge cluster trial whereby all clusters (practice sites) begin as part of the Usual Care (UC) control condition. Clusters are then randomly assigned to cross over at different times with all clusters eventually receiving PACE. The study will involve each site starting with the UC, followed by a period of 3 months during which practice facilitators will train NCMs and CHWs, and finally followed by the PACE intervention for 12 months with a 6-month follow-up for outcome assessment. During the UC Period, patients at the sites will receive standard HTN care and standard printed HTN treatment guidelines. Immediately following this period, prior to implementation of PACE, we will conduct a practice capacity assessment at each site for 3 months. This period is then followed by the implementation of PACE. |
| Intervention Group | Experimental | Other: Practice support And Community Engagement (PACE)Thus, each cluster will belong successively to the control group and the intervention group. During the control period (UC) patients at the sites will receive standard HTN care delivered by their primary care providers and standard printed HTN treatment guidelines. This period is then followed by the implementation of PACE. Clusters are randomly assigned to cross over at different times with all clusters eventually receiving PACE. During the PACE implementation period, which will last 12 months, practice facilitators will work with each site to implement the components of PACE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- identifies as Black (through EHR code or self-report)
- is 18+ years of age
- has a diagnosis of HTN (identified by ICD-10 codes for HTN)
- prescribed an antihypertensive medication(s)
- has a clinic BP > 130/80 mmHg
Key exclusion criteria (14 listed)
- are deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks)
- participate in other hypertension-related clinical trials
- have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
- plan to discontinue care at the site within the next 12 months; or
- are pregnant or planning to become pregnant in the next 12 months
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 |
|---|---|---|
| Practice support And Community Engagement (PACE)A practical and sustainable implementation strategy, referred to as Practice Facilitation And social deTerminants of health support utilizing CHWs (PATCH), to support the implementation and evaluation of three multi-level evidence-based interventions: [nurse case management (NCM) + remote blood pressure monitoring (RBPM) + social determinants of health (SDOH) support] delivered as an integrated community-clinic linkage model [Practice support And Community Engagement (PACE)] | Other | Intervention Group |
Primary outcome
Number of Nurses who adopt the PACE intervention
Time frame: Month 12
Defined at the Nurse-level who adopt both electronic health record (EHR) remote BP monitoring (RBPM) and social determinants of health (SDOH) Smartsets
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 2 Jun 2026.
- Derived from this study: PubMed 36068611Gyamfi J, Cooper C, Barber A, Onakomaiya D, Lee WY, Zanowiak J, Mansu M, Diaz L, Thompson L, Abrams R, Schoenthaler A, Islam N, Ogedegbe G. Needs assessment and planning for a clinic-community-based implementation program for hypertension control among blacks in New York City: a protocol paper. Implement Sci Commun. 2022 Sep 6;3(1):96. doi: 10.1186/s43058-022-00340-z.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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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.
Gbenga Ogedegbe, MD, MPH principal investigator
NYU Langone Health
Nadia Islam, PhD principal investigator
NYU Langone Health
Antoinette Schoenthaler, EdD 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 Practice support And Community Engagement (PACE) in people with Hypertension (HTN), 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 14 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: enrolling by invitation, as of the sponsor's last update on 2 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Nurses who adopt the PACE intervention (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05208450, which also lists 1 linked publication.
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 2 Jun 2026.