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?

This trial aims to determine how Community Health Workers can assist individuals with uncontrolled diabetes or high blood pressure in better managing their conditions. It evaluates a program where health workers screen for social risks and refer patients to helpful resources. The goal is to improve blood sugar levels in those with diabetes and lower blood pressure in those with hypertension. Participants should have a recent blood sugar test result over 9% or a blood pressure reading above 140/90 mmHg. As an unphased trial, this study provides a unique opportunity to contribute to innovative community health solutions.

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.

What prior data suggests that this Community Health Worker program is safe for patients with uncontrolled diabetes and hypertension?

Research has shown that programs led by community health workers (CHWs) effectively and safely manage health issues like high blood pressure and diabetes. For example, studies have found that CHW programs can help control blood pressure and improve health without causing major side effects. In New York City, these programs have successfully managed blood pressure. Similarly, a study in Kenya showed positive results from CHW-led screenings and care for high blood pressure.

Overall, the CHW approach is well-received and has not been linked to major safety concerns in past studies. This suggests that joining a CHW-led program is generally safe for people with uncontrolled diabetes or high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Health Worker (CHW) program for managing high blood pressure and diabetes because it takes a unique approach by integrating personalized social support into clinical care. Unlike standard treatments that primarily focus on medication management, this program involves CHWs who address social risk factors that can influence health, such as access to resources, lifestyle coaching, and community support. This holistic strategy could lead to better control of diabetes and hypertension by addressing root causes that medications alone may not tackle, potentially improving outcomes for patients with poorly controlled conditions.

What evidence suggests that the Community Health Worker program is effective for managing uncontrolled diabetes and hypertension?

Research has shown that Community Health Workers (CHWs) can significantly aid in managing high blood pressure and diabetes. In this trial, participants at intervention community health centers will collaborate with CHWs to conduct social risk activities as part of their clinical services. Studies have found that patients with CHWs achieve better blood pressure control than those without. Specifically, one study reported that 68.2% of patients with CHWs successfully managed their blood pressure. CHWs also help patients maintain control of their blood sugar levels (A1C), even during challenging times like the COVID-19 pandemic. This evidence suggests that CHWs play a crucial role in improving patients' health by addressing both social and healthcare needs. ^{5 6 7 8 9}

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8977767/

Approaches and outcomes of community health worker's ... Summarised outcomes of individual studies showed CHW enhanced the control and management of hypertension. Further studies are needed to indicate ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.123.009900

Community Health Workers as Key Allies in the Global ... After 6 months at trial completion, BP control was superior in the CHW intervention (68.2%, n=154) compared with control (41.6%, n=137) group (P ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06230835

Community Health Worker Led Hypertension Prevention ... About 13.5% of premature deaths, 54% of incident stroke and 47% of incident coronary heart disease (CHD) worldwide are attributed to high blood pressure (BP).

4. heart.org heart.org/en/news/2024/08/05/the-important-gap-community-health-workers-and-care-managers-can-fill

The important gap community health workers and care ... Compared to people receiving enhanced standard of care, people in these two groups made greater progress in lowering blood pressure.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524000603

Impact of community health workers on diabetes ... Patients with CHWs were better able to manage their A1C levels than patients without CHWs, both before and after the onset of the COVID-19 pandemic. •. CHWs can ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8101563/

A Community Health Worker–Led Intervention to Improve ... We analyzed the outcome of blood pressure (BP) control using pooled data from two community health worker interventions in New York City conducted between 2011 ...

7. trialx.com trialx.com/clinical-trials/listings/296550/community-health-workers-reduce-social-barriers-that-affect-the-health-of-patients-with-high-blood-pressure-and-diabetes/

Community Health Workers Reduce Social Barriers That ... The impacts of social risks on DM and HTN outcomes are most profound in the communities served by community health centers (CHCs). CHC patients ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S3050514325000342

Costs and coverage of community health worker-led ... In Nairobi, Kenya, a study of a community-based intervention described the costs and outcomes of hypertension screening and care. ... high-blood- ...

9. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/full/10.1002/jac5.70108

Outcomes of the Pharmacist and Community Health Worker ... This study highlights the effectiveness of a pharmacist-CHW cardiovascular clinic model in significantly improving blood pressure outcomes over ...