HypertensionBHEATNCT06948838
Improving Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
A study testing RBPM and MII in people with Hypertension and Hypertension Complicated, run by Boston Medical Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Hypertension Complicated
- What is being tested?
- RBPM and MII
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,895 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Sep 2025to Sep 2029
- 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 (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
Who cannot join
- Not meeting the inclusion criteria
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Boston Healthcare for the Homeless (BHCHP)
Boston, Massachusetts, 02118
- Recruiting
Boston Medical Center Family Medicine
Boston, Massachusetts, 02118
- Recruiting
Boston Medical Center, General Internal Medicine primary care
Boston, Massachusetts, 02118
- Recruiting
Neighborhood Health
Boston, Massachusetts, 02118
- Recruiting
Mattapan Community Health Center
Boston, Massachusetts, 02126
- Recruiting
Manet Community Health Center
Quincy, Massachusetts, 02169
- Recruiting
Greater Roslindale Medical and Dental Center (GRMDC)
Roslindale, Massachusetts, 02131
About this study
Official title: Comparative Effectiveness of Interventions to Improve Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
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.
Read the detailed description
A hybrid type 1 effectiveness-implementation study will be implemented to evaluate the comparative impact of each intervention on clinical outcomes while also assessing implementation at each site. The multi-site cluster randomized stepped-wedge design allows for feasible resource allocation and sequential roll out of the interventions for comparison, ensuring each site has the opportunity to benefit from both approaches. Data will be collected for multiple patient reported outcomes (PROs) to understand the range of impacts of the interventions from the patient perspective.
The specific aims are to:
- Assess comparative effectiveness of remote BP monitoring (RBPM) versus RBPM + multilevel intensification intervention (MII) on HTN control and quality of care. Prior research has demonstrated the effectiveness of each of these interventions yet the optimal approach to achieve equity in HTN control in safety net practices remains unknown.
- Use mixed methods, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, to assess implementation of the two comparators as measured by reach, adoption, implementation (fidelity) and maintenance. Using a convergent parallel design, the investigators will use concurrent quantitative and qualitative data to obtain perspectives across multiple levels to understand the reasons for success or failure of implementation of each comparator. By merging these data, integration can be achieved by using qualitative themes related to implementation to support or refute quantitative findings of reach and fidelity.
- Evaluate the comparative impacts of each intervention on PROs assessed with validated measures of patient activation, medication adherence, and trust in medical settings. The study intervention approaches were informed by direct feedback from the targeted diverse patients and clinical providers to address patient-reported barriers to HTN control: lack of activation, adherence to medications, and trust in their care providers.
- Conditions
- Hypertension, Hypertension Complicated
- Being tested
- RBPM, MII
- 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
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBPMBehavioural
Standardized blood pressure measurement and treatment protocols in clinical practice.
MIIOther
Team-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications.
| Study group | Role | What they receive |
|---|---|---|
| Remote Blood Pressure Monitoring (RBPM) | Experimental | Individual level interventions fo monitor blood pressure. Receives: Behavioral: RBPM |
| Multilevel Intensification interventions (MII) | Experimental | Team-based interventions to mitigate clinical inertia which is the lack of intensification of treatment despite inadequate disease control such as for HTN. Receives: Behavioral: RBPM; Other: MII |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (SBP) improvement
Change in BP abstracted from the electronic health record (EHR).
Measured: Baseline, every 3 months up to 54 months
Interventions received
The number and proportion of individuals who receive each intervention.
Measured: Baseline, 54 months
Patient activation
Patient activation will be assessed with the Consumer Health Activation index (CHAI), a 10 item validated instrument that generates a score of 0-100, with ≥80 indicating moderate/high activation.
Measured: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Secondary outcomes (6)
Blood pressure control
Assessed as Yes/No from EHR records for Systolic BP<140 mmHg and Systolic BP<130 mmHg.
Measured: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Medication intensification
Assessed from EHR and claims data.
Measured: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
BP monitoring
Assessed by EHR data on the frequency of BP monitoring.
Measured: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Fidelity of interventions
The number and proportion of individuals who receive all key elements of the interventions based on EHR data.
Measured: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Medication adherence
the 3-item self-report scale by Wilson will be used to assess this outcome. It queries patients about how many days they missed medications and overall consistency over the last 30 days. This measure has been standardized to a 0-100 scale, with good adherence defined as ≥80.
Measured: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Trust in primary care
Assessed with the 10 item Wake Forest Physician Trust Scale. The scale uses a 5-point Likert scale [1=strongly disagree to 5=strongly agree]. Total scores can range from 10 to 50, and higher scores represent greater trust.
Measured: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start8 Sep 2025
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (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 Boston Medical CenterThe 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
- Sequential
- Model description
- A hybrid type 1 effectiveness-implementation study with a cluster randomized stepped wedge study design will be used. This will be a longitudinal repeated measures design. RBPM will begin for all clusters in September, 2025. At the end of month 12, MII implementation will begin for the group in the first wedge, with the second and third groups implementing at 6-month intervals thereafter. All sites will continue interventions as part of ongoing operations, with final long-term follow-up assessment at the end of month 54.
- Masking
- None (open label)
- Enrolment
- 16,895 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Boston Healthcare for the Homeless Program (BHCHP), Boston Medical Center General Internal Medicine primary care (BMC GIM), Boston Medical Center Family Medicine Primary Care (BMC FM), NeighborHealth Center Family Medicine at Maverick Street (NH FM), NeighborHealth Center Internal Medicine at Gove Street (NH IM), NeighborHealth South End (NH South End), Manet Community Health Center (Maner CHC), Mattapan Community Health Center (Mattapan), Greater Roslindale Medical and Dental Center (GRMDC), Boston University School of Public Health (BUSPH), BUSPH Biostatistics and Epidemiology Data Analytics Center (BEDAC)
- Responsible party
- Sponsor
- Investigators
- Michael Fischer, MD MS, Principal investigator, Boston Medical Center, Internal MedicineCheryl Clark, MD ScD, Principal investigator, Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948838
- Sponsor's protocol ID
- H-45398
- Other IDs
- HMC-2023C2-33345
- Acronym
- BHEAT
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Interventions to Improve Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
- ClinicalTrials.gov ID
- NCT06948838
- Acronym / sponsor ID
- BHEAT / H-45398
- Conditions
- Hypertension, Hypertension Complicated
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16,895 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Boston Healthcare for the Homeless Program (BHCHP), Boston Medical Center General Internal Medicine primary care (BMC GIM), Boston Medical Center Family Medicine Primary Care (BMC FM), NeighborHealth Center Family Medicine at Maverick Street (NH FM), NeighborHealth Center Internal Medicine at Gove Street (NH IM), NeighborHealth South End (NH South End), Manet Community Health Center (Maner CHC), Mattapan Community Health Center (Mattapan), Greater Roslindale Medical and Dental Center (GRMDC), Boston University School of Public Health (BUSPH), BUSPH Biostatistics and Epidemiology Data Analytics Center (BEDAC)
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 29 Apr 2025 (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.
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.
Detailed description
A hybrid type 1 effectiveness-implementation study will be implemented to evaluate the comparative impact of each intervention on clinical outcomes while also assessing implementation at each site. The multi-site cluster randomized stepped-wedge design allows for feasible resource allocation and sequential roll out of the interventions for comparison, ensuring each site has the opportunity to benefit from both approaches. Data will be collected for multiple patient reported outcomes (PROs) to understand the range of impacts of the interventions from the patient perspective.
The specific aims are to:
- Assess comparative effectiveness of remote BP monitoring (RBPM) versus RBPM + multilevel intensification intervention (MII) on HTN control and quality of care. Prior research has demonstrated the effectiveness of each of these interventions yet the optimal approach to achieve equity in HTN control in safety net practices remains unknown.
- Use mixed methods, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, to assess implementation of the two comparators as measured by reach, adoption, implementation (fidelity) and maintenance. Using a convergent parallel design, the investigators will use concurrent quantitative and qualitative data to obtain perspectives across multiple levels to understand the reasons for success or failure of implementation of each comparator. By merging these data, integration can be achieved by using qualitative themes related to implementation to support or refute quantitative findings of reach and fidelity.
- Evaluate the comparative impacts of each intervention on PROs assessed with validated measures of patient activation, medication adherence, and trust in medical settings. The study intervention approaches were informed by direct feedback from the targeted diverse patients and clinical providers to address patient-reported barriers to HTN control: lack of activation, adherence to medications, and trust in their care providers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A hybrid type 1 effectiveness-implementation study with a cluster randomized stepped wedge study design will be used. This will be a longitudinal repeated measures design. RBPM will begin for all clusters in September, 2025. At the end of month 12, MII implementation will begin for the group in the first wedge, with the second and third groups implementing at 6-month intervals thereafter. All sites will continue interventions as part of ongoing operations, with final long-term follow-up assessment at the end of month 54.
| Arm | Type | Receives |
|---|---|---|
| Remote Blood Pressure Monitoring (RBPM) | Experimental | Behavioral: RBPMIndividual level interventions fo monitor blood pressure. |
| Multilevel Intensification interventions (MII) | Experimental | Behavioral: RBPM, Other: MIITeam-based interventions to mitigate clinical inertia which is the lack of intensification of treatment despite inadequate disease control such as for HTN. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
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 |
|---|---|---|
| RBPMStandardized blood pressure measurement and treatment protocols in clinical practice. | Behavioural | Multilevel Intensification interventions (MII), Remote Blood Pressure Monitoring (RBPM) |
| MIITeam-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications. | Other | Multilevel Intensification interventions (MII) |
Primary outcome
Systolic blood pressure (SBP) improvement
Time frame: Baseline, every 3 months up to 54 months
Change in BP abstracted from the electronic health record (EHR).
Interventions received
Time frame: Baseline, 54 months
The number and proportion of individuals who receive each intervention.
Patient activation
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Patient activation will be assessed with the Consumer Health Activation index (CHAI), a 10 item validated instrument that generates a score of 0-100, with ≥80 indicating moderate/high activation.
6 secondary outcomes
Blood pressure control
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Medication intensification
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
BP monitoring
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Fidelity of interventions
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Medication adherence
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Trust in primary care
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
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 30 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Michael Fischer, MD MS principal investigator
Boston Medical Center, Internal Medicine
Cheryl Clark, MD ScD principal investigator
Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RBPM and MII in people with Hypertension and Hypertension Complicated, run by Boston Medical Center at 7 sites 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 3 inclusion and 1 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Michael Fischer, MD MS ((617) 414-7288, Michael.Fischer@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (SBP) improvement (time frame: Baseline, every 3 months up to 54 months). The study lists 3 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 30 Sep 2026.