Community Health Worker Program for High Blood Pressure and Diabetes

((CHW-SYSTIM) Trial)

Recruiting at 2 trial locations

Overseen By Denita Walston, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Morehouse School of Medicine

Disqualifiers: Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this mixed-methods study is to assess the impact of a Community Health Worker (CHW)-led social risk screening and referral in improving management of uncontrolled diabetes (DM) and hypertension (HTN) among patients receiving care in community health centers (CHCs or health centers). The intervention is focused on adult health center patients with uncontrolled DM and/or HTN. Study findings will provide important evidence to guide CHCs in implementing programs to address social risks in their patient populations. Findings will illuminate whether and how CHW-led interventions to address social needs yield the hypothesized outcomes. The aims of the study are: * AIM 1: Measure how effective the CHW-led social risk program is at reducing blood sugar levels (A1C) in CHC patients with uncontrolled DM and lowering blood pressure in CHC patients with uncontrolled HTN. * AIM 2: Identify effective strategies for increasing and expanding CHW-led social risk programs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on social risk screening and referral, so you may not need to change your medication routine.

Is the Community Health Worker Program safe for managing high blood pressure and diabetes?

The Community Health Worker Program has been positively received by patients and is considered safe, as it focuses on education and support rather than medical treatments. Participants have reported improved satisfaction with accessing health services and better overall health outcomes. ^{1 2 3 4 5}

How is the Community Health Worker treatment different from other treatments for high blood pressure and diabetes?

The Community Health Worker (CHW) treatment is unique because it involves trained community members who provide culturally relevant education and support to patients, which can be particularly effective in minority and immigrant communities. Unlike traditional medical treatments, CHWs focus on improving health outcomes through personalized care and community engagement. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Community Health Workers for high blood pressure and diabetes?

Research shows that community health workers can improve care and health outcomes for people with chronic diseases like high blood pressure and diabetes. They help by educating patients, monitoring health, and connecting them with healthcare services, which leads to better management of these conditions. ^{4 7 9 10 11}

Who Is on the Research Team?

Megan Douglas, JD

Principal Investigator

Morehouse School of Medicine

Rachel Gold, PhD, MPH

Principal Investigator

OCHIN, Inc.

Katherine Chung-Bridges, MD, MPH

Principal Investigator

Health Choice Network (HCN)

Are You a Good Fit for This Trial?

This trial is for adults with uncontrolled diabetes or high blood pressure who are being treated at community health centers. It aims to see if help from Community Health Workers can improve their condition by addressing social factors.

Inclusion Criteria

My latest A1c test result is 9% or higher.

I have high blood pressure with readings of 140/90 mmHg or higher.

Exclusion Criteria

Pregnant people

I am under 18 years old.

I do not have Type 2 diabetes or hypertension.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Community Health Workers (CHWs) conduct social risk activities and refer patients to social services as part of clinical services for patients with uncontrolled diabetes and hypertension.

12 months

Regular CHW contacts

Follow-up

Participants are monitored for improvements in health outcomes such as blood sugar levels and blood pressure, and successful linkage to social services.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Workers

Trial Overview The study tests a program where Community Health Workers screen patients for social risks and refer them to resources. It's a randomized control trial, meaning some health centers will use the program and others won't, to compare results.

How Is the Trial Designed?

Group I: Intervention Community Health Centers Experimental Treatment 1 Intervention

Community Health Centers (CHC) will identify a Community Health Worker (CHW) or similar staff member who will conduct social risk activities as part of clinical services for all CHC patients with uncontrolled diabetes (DM) and hypertension (HTN) as defined by Uniform Data System (UDS). If needed due to resource constraints, a prioritization scheme may be applied to target patients with the most poorly controlled DM / HTN, those newly diagnosed, those at selected CHC-run sites, etc.; this scheme will be refined in the intervention development phase.

Group II: Control Community Health Centers Active Control 1 Intervention

Control CHC data on enabling services and associated workflows will be gathered through qualitative methods for a deeper understanding of the intervention impact. At the end of the intervention year, control CHCs will receive: (1) participation in the end of intervention summative CHW convening for crossover training led by the intervention arm CHWs; and 2) a toolkit designed to support their adoption of the intervention processes. This will both support the dissemination of intervention elements identified as effective (as feasible), and recruitment activities (by ensuring that all study FQHCs receive something through study participation).

Who Is Running the Clinical Trial?

Morehouse School of Medicine

Lead Sponsor

Trials

22

Recruited

16,300+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Health Choice Network

Collaborator

Trials

6

Recruited

5,820,000+

Westat

Collaborator

Trials

49

Recruited

39,700+

OCHIN, Inc.

Collaborator

Trials

24

Recruited

9,964,000+

Published Research Related to This Trial

In a randomized controlled trial involving 421 participants with elevated blood pressure, enhanced tracking and follow-up services by community health workers significantly improved medical follow-up rates by 39.4% compared to usual care.

The intervention led to 65.1% of participants completing a follow-up visit within 90 days, compared to only 46.7% in the usual-care group, demonstrating the effectiveness of community health worker support in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. Krieger, J., Collier, C., Song, L., et al.[2019]

Community health workers (CHWs) significantly improve care quality and health outcomes for chronic diseases, particularly hypertension, by enhancing access to care and treatment adherence among underserved populations.

CHWs play vital roles in patient education, monitoring health, and facilitating communication between patients and providers, but challenges remain in integrating them into healthcare teams effectively, requiring sustainable funding and policy changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers as interventionists in the prevention and control of heart disease and stroke. Brownstein, JN., Bone, LR., Dennison, CR., et al.[2022]

The diabetes education program for community health workers led to significant improvements in patients' lipid profiles, with reductions in total cholesterol and triglycerides, indicating potential benefits beyond just blood sugar control.

While both the intervention and control groups showed a decrease in HbA1c levels, the changes were not statistically different between the two groups, suggesting that the education program did not have a unique impact on blood sugar levels compared to standard health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial. de Souza, CF., Dalzochio, MB., Zucatti, ATN., et al.[2022]

The community health worker (CHW) program significantly improved patient satisfaction with accessing health services and community resources among 13 patients with type 2 diabetes.

Patients viewed the CHW program positively, indicating it could effectively address their health and social needs in safety net healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Perspectives on the Feasibility, Acceptability, and Impact of a Community Health Worker Program: A Qualitative Study. Chang, W., Oo, M., Rojas, A., et al.[2021]

A training program for community health workers (CHWs) focused on hypertension and diabetes management was successfully implemented for 12 Korean-American seniors, with all participants achieving a minimum knowledge level of 70%.

The training was well-received, with an average satisfaction rating of 9.3 out of 10, indicating that CHWs felt empowered in their roles, although further research is needed to assess the actual impact on health outcomes in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the training of Korean community health workers for chronic disease management. Han, HR., Kim, KB., Kim, MT.[2022]

Community health workers (CHWs) significantly improve blood pressure control in patients, as shown in seven out of eight randomized controlled trials (RCTs) reviewed, particularly among underserved urban African American populations.

CHWs also enhance self-management behaviors related to hypertension, such as medication adherence and appointment attendance, indicating their valuable role in multidisciplinary healthcare teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in the care of people with hypertension. Brownstein, JN., Chowdhury, FM., Norris, SL., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Protocol and baseline characteristics for a community health worker-led hypertension and diabetes management program for South Asians in Atlanta: The DREAM Atlanta study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. [2019]

3. Brazil pubmed.ncbi.nlm.nih.gov

Contribution of community health workers to primary health care performance in Brazil. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Community health workers as interventionists in the prevention and control of heart disease and stroke. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Community Health Worker-Led Intervention to Improve Blood Pressure Control in an Immigrant Community With Comorbid Diabetes: Data From Two Randomized, Controlled Trials Conducted in 2011-2019. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Patients' Perspectives on the Feasibility, Acceptability, and Impact of a Community Health Worker Program: A Qualitative Study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of the training of Korean community health workers for chronic disease management. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in the care of people with hypertension. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Community Health Worker Program Outcomes for Diabetes and Hypertension Control in West Bank Refugee Camps: A Retrospective Matched Cohort Study. [2022]