Recruiting

Hypertension Management

Sponsor:

Boston Medical Center

Code:

NCT06948838

Conditions

Hypertension

Hypertension Complicated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RBPM

MII

Study Details

Brief summary:

High blood pressure (BP) or hypertension (HTN) affects over 100 million individuals in the US, increasing the risk of adverse outcomes, including stroke, myocardial infarction (MI), and chronic kidney disease (CKD). Effective therapies include non-pharmacologic approaches and multiple medication classes. Successful HTN management requires ongoing patient engagement for BP monitoring and treatment intensification. Reaching this goal is challenging, and many patients with HTN do not have controlled BP.

Using a collaborative partnership between patients, clinicians, health system and public health stakeholders, and the research team the investigators plan to overcome barriers to widespread implementation of evidence-based health system strategies to improve BP control in a large, urban, primary care-based safety-net setting for diverse populations experiencing disparities in HTN-related outcomes.

Conditions

Hypertension

Hypertension Complicated

Study ID

NCT06948838

Start date

Sep 8, 2025

Status verified date

Oct, 2025

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult (age>18) patients receiving primary care at one of the 9 participating sites, with primary care provider (PCP) visit in the preceding year
  • Presence of HTN defined by one or more of: 1) diagnosis included on active problem list, 2) active HTN medications in prior year, 3) 3 separate elevated BP measurements
  • Uncontrolled HTN defined as systolic blood pressure (SBP)>140

Exclusion Criteria:

  • Not meeting the inclusion criteria

Study Design

Enrollment

16895 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Remote Blood Pressure Monitoring (RBPM)

Individual level interventions fo monitor blood pressure.

experimental: Multilevel Intensification interventions (MII)

Team-based interventions to mitigate clinical inertia which is the lack of intensification of treatment despite inadequate disease control such as for HTN.

Interventions

RBPM

Standardized blood pressure measurement and treatment protocols in clinical practice.

MII

Team-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications.

Primary outcome measure

  • Systolic blood pressure (SBP) improvement [ Time Frame: Baseline, every 3 months up to 54 months ]
  • Interventions received [ Time Frame: Baseline, 54 months ]
  • Patient activation [ Time Frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months ]

Central Contacts and Locations

Central contacts

Locations

Boston Healthcare for the Homeless (BHCHP)

Recruiting

Boston, Massachusetts, United States, 02118

Boston Medical Center Family Medicine

Recruiting

Boston, Massachusetts, United States, 02118

Boston Medical Center, General Internal Medicine primary care

Recruiting

Boston, Massachusetts, United States, 02118

Neighborhood Health

Recruiting

Boston, Massachusetts, United States, 02118

Mattapan Community Health Center

Recruiting

Boston, Massachusetts, United States, 02126

Manet Community Health Center

Recruiting

Quincy, Massachusetts, United States, 02169

Greater Roslindale Medical and Dental Center (GRMDC)

Recruiting

Roslindale, Massachusetts, United States, 02131

More Information

Sponsor

Boston Medical Center

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • Remote blood pressure monitoring (RBPM)
  • HTN management
  • HTN-related outcomes
  • Evidence-based health system strategies
  • Hybrid effectiveness-implementation study
  • PROs
  • Diverse urban area
  • Disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2025-10-14.