CHW Initiatives for Type 2 Diabetes

Overseen By Valeria Lescano

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Pregnancy, Type 1 diabetes, Schizophrenia, others

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

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for type 2 diabetes in the CHW Initiatives for Type 2 Diabetes trial?

Research shows that comprehensive care programs and quality improvement strategies can effectively improve outcomes for people with type 2 diabetes, such as better blood sugar control and overall health management. ^{1 2 3 4 5}

Is the CHW Initiatives for Type 2 Diabetes treatment generally safe for humans?

Incretin-based therapies for type 2 diabetes, which may be part of the CHW Initiatives, have been shown in clinical trials to be generally safe, with weight-neutral or weight-reducing effects and no apparent negative impact on heart health. ^{6 7 8 9 10}

How does the CHW Initiatives for Type 2 Diabetes treatment differ from other treatments?

This treatment is unique because it uses community health workers (CHWs) to provide diabetes education and support, focusing on improving patients' knowledge and self-management skills. Unlike traditional medical treatments, this approach emphasizes personalized, community-based care and has shown significant improvements in health outcomes for vulnerable populations. ^{11 12 13 14 15}

What is the purpose of this trial?

Latino(a)s suffer from poor social determinants of health (SODH) conditions more than non-minority populations, and being a minority is risk factor alone for diabetes. In the proposed study, investigators will assist church members in becoming Community Health Workers (CHWs), train them in diabetes, and to track the ability to address healthcare access and quality barriers using an online platform.

Research Team

Elizabeth Vaughan, DO

Principal Investigator

University of Texas Medical Branch, Galveston

Eligibility Criteria

This trial is for Spanish-speaking Latino adults with Type 2 Diabetes. It's not suitable for those who are pregnant, planning to be pregnant soon, have Type 1 diabetes, or have certain mental health conditions like schizophrenia or severe Alzheimer's disease.

Inclusion Criteria

Spanish-speaking Latino(a)s adults

Exclusion Criteria

I do not speak Spanish.

I have been diagnosed with Type 1 diabetes.

Pregnant state or anticipated state in the next 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Church members are trained to become Community Health Workers (CHWs) and educated on diabetes management

4 weeks

Weekly training sessions

Intervention

Implementation of a 6-month church-based intervention for Latino(a)s with and at risk for diabetes, including the use of an online platform to track healthcare access and quality barriers

6 months

Monthly telementoring sessions

Follow-up

Participants are monitored for the effectiveness of the intervention, including CHW ability to use software and participant knowledge

4 weeks

Treatment Details

Interventions

• Diabetes Program

Trial Overview The study aims to train church members as Community Health Workers (CHWs) and use an online platform to improve healthcare access and quality for Latinos with diabetes. The effectiveness of this community-based diabetes program will be evaluated.

Participant Groups

Group I: Diabetes program and education Experimental Treatment 1 Intervention

Receive diabetes program and education

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Findings from Research

A disease management program for diabetes in a health maintenance organization led to significant improvements in glycemic control, with mean HbA1c levels decreasing from 8.51% at baseline to 7.41% after 3 months and 1 year of follow-up among participants.

The program also influenced medication use, with increases in insulin and metformin, suggesting that the structured support and education provided by the program played a crucial role in managing diabetes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease management for diabetes mellitus: impact on hemoglobin A1c. Sidorov, J., Gabbay, R., Harris, R., et al.[2022]

The quality improvement program significantly enhanced the adherence to diabetes care guidelines among 312 patients, with notable increases in care measures such as blood pressure monitoring (odds ratio of 12.08) and urine albumin testing (odds ratio of 2.43).

Despite improvements in the provision of care, the program did not lead to any measurable benefits in patient outcomes, such as blood pressure or HbA1c levels, over a follow-up period of 42 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of a quality improvement program for patients with type 2 diabetes in general practice. Renders, CM., Valk, GD., Franse, LV., et al.[2022]

Current strategies for managing type 2 diabetes, such as enhancing provider adherence to guidelines and promoting lifestyle changes, have shown mixed results, highlighting the complexity of motivating patient behavior change.

Implementing coaching communication by nurse practitioners during primary care visits may offer a cost-effective way to improve patient self-management of type 2 diabetes, but requires further education and validation of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alliance not compliance: coaching strategies to improve type 2 diabetes outcomes. Hayes, E., McCahon, C., Panahi, MR., et al.[2008]

A comprehensive management program for diabetes at Kaiser Permanente Northwest led to significant improvements in patient care, with 83% of members receiving annual glycemic control tests and increased screening rates for complications like retinopathy and nephropathy.

Over the 10-year study, there was a notable decrease in mortality rates among diabetes patients (from 4.8% to 3.6%) and improvements in health metrics such as blood pressure and cholesterol levels, indicating enhanced overall health outcomes for those with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case-control study of 10 years of comprehensive diabetes care. Brown, JB., Nichols, GA., Glauber, HS.[2019]

The CAIPaDi program, which includes 9 interventions over 7 hours, effectively helped 80.6% of participants achieve an HbA1c level below 7% after the initial 4 visits, indicating strong short-term efficacy in managing type 2 diabetes.

Sustained improvements were observed over 24 months, with 61.0% of patients maintaining HbA1c <7%, and significant enhancements in empowerment and quality of life, while anxiety and depression levels remained low, suggesting the program's holistic approach is beneficial for long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of a type 2 diabetes comprehensive care program. The CAIPaDi model. Hernández-Jiménez, S., García-Ulloa, AC., Bello-Chavolla, OY., et al.[2019]

An integrative review of 21 studies identified 13 key patient safety domains that impact the home care of older adults with diabetes, highlighting significant risks such as hypoglycemia, falls, and foot ulcers.

The findings reveal a critical knowledge gap among care providers regarding diabetes management, which increases the risk of adverse events for older patients, emphasizing the need for improved training and assessment skills in home care services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative review: Patient safety among older people with diabetes in home care services. Haltbakk, J., Graue, M., Harris, J., et al.[2020]

Incretin-based therapies, such as DPP-4 inhibitors and GLP-1 agonists, provide effective glycemic control for type 2 diabetes patients without the weight gain often seen with traditional treatments, making them a favorable option for many.

Clinical trial data suggest that these therapies are safe, showing no negative effects on cardiovascular health, and their integration into treatment plans can enhance options for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New therapeutic options: management strategies to optimize glycemic control. Freeman, JS.[2022]

A significant increase in unintentional therapeutic errors involving insulin was observed over a 10-year period, with a 495% rise in annual incidence, particularly affecting adults over 40 years old and predominantly women.

Most of these errors occurred in non-healthcare settings, especially during late evening hours, highlighting the need for better management strategies and the importance of poison control centers as a resource for affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unintentional therapeutic errors involving insulin in the ambulatory setting reported to poison centers. Spiller, HA., Borys, DJ., Ryan, ML., et al.[2011]

A symposium with 31 healthcare professionals highlighted that preventing adverse events in community care requires a multi-faceted approach involving policy changes at various levels, including system integration and improved communication among providers.

Key recommendations from the symposium include prioritizing education for clinicians and caregivers, enhancing organizational culture, and leveraging technology to improve patient safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. Masotti, P., Green, M., McColl, MA.[2019]

A study analyzing 751 suspected adverse drug reactions (ADRs) in older patients with diabetes revealed that most were serious, with 199 leading to hospitalization and 19 resulting in death, primarily affecting females aged 65-74.

The most common ADRs reported were hypoglycemia and lactic acidosis, both of which are often preventable, emphasizing the need for careful monitoring and management of diabetes medications in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of suspected adverse drug reactions in elderly patients with diabetes mellitus based on a Portuguese spontaneous reporting database: analysis of reporting from 2008 to 2018. Monteiro, C., Silvestre, S., Duarte, AP., et al.[2022]

A 2.5-month diabetes education training for community health workers (CHWs) significantly improved their diabetes knowledge, as evidenced by pre- and post-test results from the Diabetes Knowledge Questionnaire (DKQ).

The training utilized diverse methods, including case studies and role-playing, highlighting the need for standardized diabetes competencies and evaluative tools tailored specifically for CHWs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Training for Community Health Workers. Aponte, J.[2020]

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]

In a study involving 116 participants, primarily Native Hawaiian and Samoan, community health workers (CHWs) significantly improved diabetes management, leading to a mean reduction in HbA1c of 2.2% for those receiving CHW support.

In contrast, participants without CHW intervention only experienced a minimal reduction of 0.2% in HbA1c, highlighting the effectiveness of CHWs in enhancing diabetes education and management in ethnic minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes management: utilizing community health workers in a Hawaiian/Samoan population. Beckham, S., Bradley, S., Washburn, A., et al.[2022]

The study demonstrated that community health workers (CHWs) significantly improved diabetes management outcomes, such as HbA1c levels and diabetes knowledge, among Mexican American adults with type 2 diabetes in the Rio Grande Valley over one year.

Despite improvements in various health metrics, the intervention did not lead to significant changes in body mass index (BMI), indicating that while CHWs can enhance diabetes education and self-management, weight loss may require additional strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of community health workers in combating type 2 diabetes in the rio grande valley. Ryabov, I., Richardson, C.[2013]

The community health worker (CHW) model shows promise in diabetes management, with eight studies reviewed highlighting various roles such as educator and advocate, but the effectiveness and implementation details vary widely across programs.

There is a lack of consensus on the specific roles and training of CHWs in diabetes programs, indicating a need for more rigorous research to optimize their integration into chronic disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying the community health worker model to diabetes management: using mixed methods to assess implementation and effectiveness. Cherrington, A., Ayala, GX., Amick, H., et al.[2011]

References

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

Disease management for diabetes mellitus: impact on hemoglobin A1c. [2022]

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

Long-term effectiveness of a quality improvement program for patients with type 2 diabetes in general practice. [2022]

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

Alliance not compliance: coaching strategies to improve type 2 diabetes outcomes. [2008]

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

Case-control study of 10 years of comprehensive diabetes care. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of a type 2 diabetes comprehensive care program. The CAIPaDi model. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Integrative review: Patient safety among older people with diabetes in home care services. [2020]

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

New therapeutic options: management strategies to optimize glycemic control. [2022]

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

Unintentional therapeutic errors involving insulin in the ambulatory setting reported to poison centers. [2011]

9. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Assessment of suspected adverse drug reactions in elderly patients with diabetes mellitus based on a Portuguese spontaneous reporting database: analysis of reporting from 2008 to 2018. [2022]

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

Diabetes Training for Community Health Workers. [2020]

12. 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]

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

Diabetes management: utilizing community health workers in a Hawaiian/Samoan population. [2022]

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

The role of community health workers in combating type 2 diabetes in the rio grande valley. [2013]

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

Applying the community health worker model to diabetes management: using mixed methods to assess implementation and effectiveness. [2011]