HypertensionNCT06730230
Partners in Control, Phase II: Using Remote Monitoring Technology With Community Health Workers to Support Hypertension Management for Latinx Patients
A study testing Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support in people with Hypertension, run by NYU Langone Health at 1 site in United States.
Trial summary
This study seeks to evaluate the impact of a remote patient monitoring (RPM)-specific tech-enabled community health worker workforce on the use of RPM for the management of hypertension among Latinx patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to 31 May 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
- Self-identify as Latinx
- Be fluent in English or Spanish
- Be age 18 years or older
- Receiving care at one of the 10 safety-net primary care clinics
- 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)
- Have been prescribed at least one anti-hypertensive medication and be non-adherent to their medications, defined as adherence <80% in the preceding 12 months, as determined by prescription orders obtained from the clinic EHR.
Who cannot join
- Being 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)
- Participation 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 clinic within the next 15 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
This study seeks to evaluate the impact of a remote patient monitoring (RPM)-specific tech-enabled community health worker workforce on the use of RPM for the management of hypertension among Latinx patients. This study is a step-wedge randomized controlled trial that aims to assess the effectiveness and implementation of RPM-enabled community health workers (CHWs) compared to standard of care RPM hypertension management on blood pressure reduction and evaluate the implementation of the RPM-enabled CHWs for hypertension (HTN) management. The study aims to examine adoption, acceptability, fidelity, cost, sustainability, and equity as outcomes of implementation effectiveness.
- Conditions
- Hypertension
- Being tested
- Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) SupportBehavioural
CHWs will implement RPM by being provided with training modules and implementing electronic health record (EHR) support tools for HTN management.
| Study group | Role | What they receive |
|---|---|---|
| Latinx patients with uncontrolled hypertension (HTN) | Experimental | Patients will be exposed to the RPM-enabled CHW support, this will be carried out through the step-wedge design, meaning that over the course of the study (~18 months), all clinics will carry out standard HTN care and also have exposure to the intervention (though at varying time intervals). Receives: Behavioral: Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
Measured: Baseline, Month 18
Change in diastolic blood pressure
Measured: Baseline, Month 18
Secondary outcomes (1)
Rate of hypertension control
Outcome measure will be assessed using the National Quality Forum-defined thresholds for controlled/uncontrolled hypertension (BP<140/90 mmHg).
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start10 Feb 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (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
- Not applicable
- Intervention model
- Single group
- Model description
- With the stepped-wedge design, each clinic will function as a control or "usual care" group prior to the implementation of the intervention. During this period, the clinic will prescribe and treat patients enrolled in the RPM hypertension program using usual protocols.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Devin Mann, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730230
- Sponsor's protocol ID
- 23-00746
- Other IDs
- 1R01MD018520-01A1
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Devin.Mann@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partners in Control, Phase II: Using Remote Monitoring Technology With Community Health Workers to Support Hypertension Management for Latinx Patients
- ClinicalTrials.gov ID
- NCT06730230
- Acronym / sponsor ID
- 23-00746
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 12 Dec 2024 (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 seeks to evaluate the impact of a remote patient monitoring (RPM)-specific tech-enabled community health worker workforce on the use of RPM for the management of hypertension among Latinx patients. This study is a step-wedge randomized controlled trial that aims to assess the effectiveness and implementation of RPM-enabled community health workers (CHWs) compared to standard of care RPM hypertension management on blood pressure reduction and evaluate the implementation of the RPM-enabled CHWs for hypertension (HTN) management. The study aims to examine adoption, acceptability, fidelity, cost, sustainability, and equity as outcomes of implementation effectiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- With the stepped-wedge design, each clinic will function as a control or "usual care" group prior to the implementation of the intervention. During this period, the clinic will prescribe and treat patients enrolled in the RPM hypertension program using usual protocols.
| Arm | Type | Receives |
|---|---|---|
| Latinx patients with uncontrolled hypertension (HTN) | Experimental | Behavioral: Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) SupportPatients will be exposed to the RPM-enabled CHW support, this will be carried out through the step-wedge design, meaning that over the course of the study (~18 months), all clinics will carry out standard HTN care and also have exposure to the intervention (though at varying time intervals). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identify as Latinx
- Be fluent in English or Spanish
- Be age 18 years or older
- Receiving care at one of the 10 safety-net primary care clinics
- 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)
Key exclusion criteria (4 listed)
- Being 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)
- Participation 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 clinic within the next 15 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 |
|---|---|---|
| Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) SupportCHWs will implement RPM by being provided with training modules and implementing electronic health record (EHR) support tools for HTN management. | Behavioural | Latinx patients with uncontrolled hypertension (HTN) |
Primary outcome
Change in systolic blood pressure
Time frame: Baseline, Month 18
Change in diastolic blood pressure
Time frame: Baseline, Month 18
1 secondary outcome
Rate of hypertension control
Time frame: Month 18
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 4 Dec 2025.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Devin.Mann@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Devin Mann, 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 Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support 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 4 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. 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 Devin Mann, MD (212-263-8313, Devin.Mann@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 (time frame: Baseline, Month 18). The study lists 2 primary outcomes in all. 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 4 Dec 2025.