Partners in Control, Phase II: Using Remote Monitoring Te... | NCT06730230

ID	Type	Description	Link
1R01MD018520-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2025Actual

Primary Completion Date

May 31, 2026Estimated

Completion Date

May 31, 2027Estimated

First Submitted Date

Dec 9, 2024

First Submission Date that Met QC Criteria

Dec 9, 2024

First Posted Date

Dec 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2025

Last Update Posted Date

Dec 4, 2025Actual

Name	Class
National Institute on Minority Health and Health Disparities (NIMHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).	Behavioral: Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support	Behavioral	CHWs will implement RPM by being provided with training modules and implementing electronic health record (EHR) support tools for HTN management.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in systolic blood pressure		Baseline, Month 18
Change in diastolic blood pressure		Baseline, Month 18

Secondary Outcomes

Measure	Description	Time Frame
Rate of hypertension control	Outcome measure will be assessed using the National Quality Forum-defined thresholds for controlled/uncontrolled hypertension (BP<140/90 mmHg).	Month 18

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Devin Mann, MD	Contact	212-263-8313		Devin.Mann@nyulangone.org
Tiffany Martinez	Contact	646-501-2505		Tiffany.Martinez@nyulangone.org

Overall Officials

Name	Affiliation	Role
Devin Mann, MD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Health	Recruiting	New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

Access Criteria

The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Devin.Mann@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

URL

Not provided

Intervention 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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D000098465	Remote Patient Monitoring
D010166	Palliative Care

ID	Term
D017216	Telemedicine
D003695	Delivery of Health Care
D010346	Patient Care Management
D006298	Health Services Administration
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services