HypertensionCHANGENCT07136402
MA-CEAL Community Health Ambassador Program
A study testing Educating participants about healthcare resources, Healthcare appointments and Workshops in people with Hypertension and Diabetes Mellitus, run by Boston Medical Center.
Trial summary
This research is being conducted to investigate how to increase primary care health care visits and screenings and treatment for hypertension and diabetes in residents of housing developments in Boston. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Health Care Utilization
- What is being tested?
- Educating participants about healthcare resources, Healthcare appointments and Workshops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to May 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Current resident in selected Boston Health Authority (BHA) and Trinity housing developments
- Speak and understand English and/or Spanish
Who cannot join
- Does not speak English or Spanish
- Not a resident of the development
About this study
Official title: Massachusetts Community Engaged Alliance (MA-CEAL) Community Health Ambassador Program
This research is being conducted to investigate how to increase primary care health care visits and screenings and treatment for hypertension and diabetes in residents of housing developments in Boston. The investigators are partnering with Boston Housing Authority (BHA) and Trinity housing management to randomize 12 housing developments (6 in intervention and 6 in control). 6 residents from the housing developments will become Community Health Ambassadors (CHA). The CHAs will be trained to conduct "workshops" within the intervention arm. These workshops will cover Diabetes Mellitus (DM) and Hypertension (HTN) information. Along with the workshops, CHAs will act as mentors for the residents and provide them with resources to connect them to primary care, Community Health Centers, food pantry resources, how to get insurance, and other needed services. CHAs will be part-time employees of the Massachusetts Community Engaged Alliance (MA-CEAL), so they will be paid for the work they are doing while simultaneously building their professional skill set.
MA-CEAL's community engagement (CE) team will act as liaisons and mentors for the CHA's to help guide them and also connect them to opportunities for career/personal development.
- Conditions
- Hypertension, Diabetes Mellitus, Health Care Utilization
- Being tested
- Educating participants about healthcare resources, Healthcare appointments, Workshops
- Keywords
- Community health ambassadors (CHA), Community health centers, Workshops
- Medical subject headings
- Hypertension, Diabetes Mellitus, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educating participants about healthcare resourcesOther
MA-CEAL team members, including the community health ambassador (CHA), will assist in connecting residents with healthcare resources.
Healthcare appointmentsOther
MA-CEAL team members, including the community health ambassador (CHA), will assist residents in making physician appointments.
WorkshopsOther
Trained CHAs will provide workshops with information about diabetes and hypertension and how to be screened and get care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Phase A) | Experimental | Community health centers randomized into this arm will receive study interventions in the first 18 months of the study. Receives: Other: Educating participants about healthcare resources; Other: Healthcare appointments; Other: Workshops |
| Control (Phase B) | Experimental | Community health centers randomized into this arm will be wait listed and will not receive study interventions during the first 18 months of the study. They will receive study interventions during the last 12 months of the study. Receives: Other: Educating participants about healthcare resources; Other: Healthcare appointments; Other: Workshops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of primary care visits
Self-report primary care visits in the last 18 months will be obtained using selected items from the National Health Interview Survey (NHIS)
Measured: Baseline, 6 months, 12 months, 18 months
Secondary outcomes (2)
Number of screenings for diabetes
Self-reported by participants in a study questionnaire
Measured: Baseline, 6 months, 12 months, 18 months
Number of screenings for hypertension
Self-reported by participants in a study questionnaire
Measured: Baseline, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Why it stopped: Withdrawn for study design changes prior to implementation of the study. No participants were enrolled.
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.
- 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
- Parallel groups
- Model description
- A waitlist-control trial design will be used for this study. 6 of the 12 participating housing developments will be randomized into the intervention arm and 6 into the control arm. At month 0 all participants will participate in baseline activities (surveys). At month 18 the control arm will begin the intervention. The whole study is projected to take 36 months.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Massachusetts Community Engaged Alliance (MA-CEAL)
- Responsible party
- Sponsor
- Investigators
- Benjamin Linas, MD MPH, Principal investigator, Boston Medical Center, Infectious Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136402
- Sponsor's protocol ID
- H-45218
- Other IDs
- OT2HL158287
- Acronym
- CHANGE
- Status last verified
- Sep 2025
- First submitted
- 13 May 2025
- Last updated
- 2 Oct 2025
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massachusetts Community Engaged Alliance (MA-CEAL) Community Health Ambassador Program
- ClinicalTrials.gov ID
- NCT07136402
- Acronym / sponsor ID
- CHANGE / H-45218
- Conditions
- Hypertension, Diabetes Mellitus, Health Care Utilization
- Keywords
- Community health ambassadors (CHA), Community health centers, Workshops
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn for study design changes prior to implementation of the study. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Massachusetts Community Engaged Alliance (MA-CEAL)
- Study start
- Sep 2025 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 Aug 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.
This research is being conducted to investigate how to increase primary care health care visits and screenings and treatment for hypertension and diabetes in residents of housing developments in Boston. The investigators are partnering with Boston Housing Authority (BHA) and Trinity housing management to randomize 12 housing developments (6 in intervention and 6 in control). 6 residents from the housing developments will become Community Health Ambassadors (CHA). The CHAs will be trained to conduct "workshops" within the intervention arm. These workshops will cover Diabetes Mellitus (DM) and Hypertension (HTN) information. Along with the workshops, CHAs will act as mentors for the residents and provide them with resources to connect them to primary care, Community Health Centers, food pantry resources, how to get insurance, and other needed services. CHAs will be part-time employees of the Massachusetts Community Engaged Alliance (MA-CEAL), so they will be paid for the work they are doing while simultaneously building their professional skill set.
MA-CEAL's community engagement (CE) team will act as liaisons and mentors for the CHA's to help guide them and also connect them to opportunities for career/personal development.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A waitlist-control trial design will be used for this study. 6 of the 12 participating housing developments will be randomized into the intervention arm and 6 into the control arm. At month 0 all participants will participate in baseline activities (surveys). At month 18 the control arm will begin the intervention. The whole study is projected to take 36 months.
| Arm | Type | Receives |
|---|---|---|
| Intervention (Phase A) | Experimental | Other: Educating participants about healthcare resources, Other: Healthcare appointments, Other: WorkshopsCommunity health centers randomized into this arm will receive study interventions in the first 18 months of the study. |
| Control (Phase B) | Experimental | Other: Educating participants about healthcare resources, Other: Healthcare appointments, Other: WorkshopsCommunity health centers randomized into this arm will be wait listed and will not receive study interventions during the first 18 months of the study. They will receive study interventions during the last 12 months of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current resident in selected Boston Health Authority (BHA) and Trinity housing developments
- Speak and understand English and/or Spanish
Key exclusion criteria (2 listed)
- Does not speak English or Spanish
- Not a resident of the development
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 |
|---|---|---|
| Educating participants about healthcare resourcesMA-CEAL team members, including the community health ambassador (CHA), will assist in connecting residents with healthcare resources. | Other | Control (Phase B), Intervention (Phase A) |
| Healthcare appointmentsMA-CEAL team members, including the community health ambassador (CHA), will assist residents in making physician appointments. | Other | Control (Phase B), Intervention (Phase A) |
| WorkshopsTrained CHAs will provide workshops with information about diabetes and hypertension and how to be screened and get care. | Other | Control (Phase B), Intervention (Phase A) |
Primary outcome
Number of primary care visits
Time frame: Baseline, 6 months, 12 months, 18 months
Self-report primary care visits in the last 18 months will be obtained using selected items from the National Health Interview Survey (NHIS)
2 secondary outcomes
Number of screenings for diabetes
Time frame: Baseline, 6 months, 12 months, 18 months
Number of screenings for hypertension
Time frame: Baseline, 6 months, 12 months, 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- 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. This study is not recruiting at the moment.
Benjamin Linas, MD MPH principal investigator
Boston Medical Center, Infectious Disease
Questions about this trial
What is this clinical trial studying?
A study testing Educating participants about healthcare resources, Healthcare appointments and Workshops in people with Hypertension and Diabetes Mellitus, run by Boston Medical Center.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 primary care visits (time frame: Baseline, 6 months, 12 months, 18 months). 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 2 Oct 2025.