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Community Health Program for High Blood Pressure and Diabetes

(CHANGE Trial)

SB
BL
Overseen ByBenjamin Linas, MD MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to encourage people to visit healthcare providers and get screenings for high blood pressure and diabetes. It focuses on residents of certain housing developments in Boston. The MA-CEAL Community Health Ambassador Program will have Community Health Ambassadors lead workshops and offer support to connect residents with healthcare and other resources. Residents of participating Boston housing developments who speak English or Spanish might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to community health improvements and access valuable resources.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this program is safe for community health improvement?

Research has shown that community health programs, such as the Community Health Ambassador (CHA) Program, are generally well-received. These programs aim to improve access to healthcare and provide education. They do not involve new drugs or medical procedures, often resulting in fewer safety concerns.

Previous programs, like the Healthy Heart Ambassador Program, have demonstrated positive outcomes. Participants received helpful support and resources, with no major reports of harm or negative effects. This suggests that the CHA Program should be safe for participants.

For those considering participation, it is reassuring that similar programs have been safe and beneficial in other communities.12345

Why are researchers excited about this trial?

Researchers are excited about the MA-CEAL Community Health Ambassador Program because it takes a community-based approach to managing high blood pressure and diabetes, which is different from typical treatments like medications or lifestyle changes prescribed in a clinical setting. This program involves training community health ambassadors to connect with patients in their own communities, offering education and support tailored to their specific needs. By focusing on local involvement and personalized guidance, the program aims to improve health outcomes more effectively than standard methods that often rely solely on individual healthcare provider visits.

What evidence suggests that the MA-CEAL Community Health Ambassador Program is effective for increasing primary care visits and screenings for hypertension and diabetes?

Research has shown that community health ambassador programs can improve health outcomes for conditions like high blood pressure and diabetes. This trial will evaluate the MA-CEAL Community Health Ambassador Program. Community health centers randomized into the "Intervention (Phase A)" arm will receive study interventions in the first 18 months, while those in the "Control (Phase B)" arm will be wait-listed and receive interventions during the last 12 months. For instance, in Texas, the Healthy Heart Ambassador Program helped individuals manage their blood pressure by encouraging self-monitoring. In Florida, Project HIGH focused on diabetes and heart disease, demonstrating that health ambassadors can effectively support people in managing these conditions. These programs aim to connect individuals with regular health check-ups and provide resources to address social factors affecting health. This approach has successfully helped people take control of their health by increasing access to necessary medical care and support services.12346

Who Is on the Research Team?

BL

Benjamin Linas, MD MPH

Principal Investigator

Boston Medical Center, Infectious Disease

Are You a Good Fit for This Trial?

This trial is for residents of certain housing developments in Boston who may benefit from increased primary care visits and management of conditions like diabetes and hypertension. It's not specified who can't join, but typically those not living in the selected areas or without these health concerns wouldn't be included.

Inclusion Criteria

Current resident in selected Boston Health Authority (BHA) and Trinity housing developments
I can speak and understand English or Spanish.

Exclusion Criteria

I do not speak English or Spanish.
Not a resident of the development

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention (Phase A)

Community health centers receive study interventions, including workshops on Diabetes Mellitus and Hypertension, and mentorship by Community Health Ambassadors

18 months
Regular workshops and mentoring sessions

Control (Phase B)

Community health centers are waitlisted and do not receive interventions initially; they receive interventions in the last 12 months

12 months
Regular workshops and mentoring sessions

Follow-up

Participants are monitored for primary care visits and screenings for diabetes and hypertension

18 months
Self-reported assessments at baseline, 6, 12, and 18 months

What Are the Treatments Tested in This Trial?

Interventions

  • MA-CEAL Community Health Ambassador Program
Trial Overview The study tests a program where Community Health Ambassadors educate residents about managing diabetes and high blood pressure, help them access healthcare resources, and provide support through workshops. The effectiveness will be compared between groups with or without this intervention.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Intervention (Phase A)Experimental Treatment3 Interventions
Group II: Control (Phase B)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials
410
Recruited
890,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Massachusetts Community Engaged Alliance (MA-CEAL)

Collaborator

Citations

Implementation of Healthy Heart Ambassador to improve ...We supported 9 health centers in Texas with the implementation of the Healthy Heart Ambassador Blood Pressure Self-Monitoring (HHA) Program.
MA-CEAL Community Health Ambassador ProgramStudy Overview. This research is being conducted to investigate how to increase primary care health care visits and screenings and treatment for hypertension ...
MA-CEAL Community Health Ambassador ProgramThis study is looking at ways to help people living in Boston housing developments get more regular medical check-ups and better care for high blood pressure ( ...
Massachusetts Community Engagement Alliance ...MA-CEAL's mission is to connect communities with trustworthy information, resources, and research that aims to address social determinants of health and improve ...
Utilizing health ambassadors to improve type 2 diabetes ...Project HIGH (Helping Individuals Get Healthy) was developed to target Gadsden County, Florida and the priority areas of Diabetes and Cardiovascular Disease.
Project DetailsCommunity-engaged implementation of a safety bundle for pregnancy-related severe hypertension ... MA-CEAL Community Health Ambassador Program Study, WITHDRAWN.
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