CHW Initiatives for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
EV
Overseen byElizabeth Vaughan, DO
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Medical Branch, Galveston
Disqualifiers: Pregnancy, Type 1 diabetes, Schizophrenia, others
No Placebo Group
Trial Summary
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.
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?
Is the CHW Initiatives for Type 2 Diabetes treatment generally safe for humans?
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.1112131415
Research Team
EV
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
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Trial 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 (Behavioural Intervention)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Diabetes program and educationExperimental Treatment1 Intervention
Receive diabetes program and education
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Medical Branch at GalvestonGalveston, TX
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Who Is Running the Clinical Trial?
The University of Texas Medical Branch, Galveston
Lead Sponsor
Trials
263
Patients Recruited
55,400+
University of Houston
Collaborator
Trials
155
Patients Recruited
48,600+
Baylor College of Medicine
Collaborator
Trials
1044
Patients Recruited
6,031,000+
References
Disease management for diabetes mellitus: impact on hemoglobin A1c. [2022]To describe outcomes associated with a health maintenance organization (HMO)-sponsored disease management program for diabetes.
Long-term effectiveness of a quality improvement program for patients with type 2 diabetes in general practice. [2022]To assess the long-term effectiveness of a quality improvement program on care provided and patient outcomes in patients with diabetes.
Alliance not compliance: coaching strategies to improve type 2 diabetes outcomes. [2008]To explore strategies for improving patient outcomes in type 2 diabetes.
Case-control study of 10 years of comprehensive diabetes care. [2019]To describe the long-term clinical impact of a comprehensive management program instituted throughout a health system for members with diabetes mellitus.
Long-term effectiveness of a type 2 diabetes comprehensive care program. The CAIPaDi model. [2019]To evaluate the effectiveness of a comprehensive care program to achieve and maintain goals in patients with type 2 diabetes.
Integrative review: Patient safety among older people with diabetes in home care services. [2020]To identify diabetes specific patient safety domains that need to be addressed to improve home care of older people; to assess research from primary studies to review evidence on patient safety in home care services for older people with diabetes.
New therapeutic options: management strategies to optimize glycemic control. [2022]Management of type 2 diabetes mellitus (T2DM) can be challenging. Patients frequently present with poor glycemic control despite therapy. Other patients may be nonadherent or resistant to continuing their treatment when confronted with undesirable adverse effects, such as weight gain, that are associated with many conventional therapies. Incretin-based therapies developed to treat patients with T2DM, including oral dipeptidyl peptidase-4 inhibitor agents or glucagon-like peptide-1 agonists, offer the potential of sustained glycemic control for many patients without the adverse events associated with other classes of antihyperglycemic medications. Available safety data from clinical trials indicate that incretin-based therapies have weight-neutral or weight-reducing effects, with no apparent adverse impact on other important safety parameters, such as cardiovascular disease. The integration of these therapies into treatment algorithms, as highlighted in three case presentations, will increase treatment options for patients with T2DM.
Unintentional therapeutic errors involving insulin in the ambulatory setting reported to poison centers. [2011]Adverse drug events in the ambulatory care setting are not uncommon and can cause significant morbidity. Little research has been published on the management of adverse drug events involving insulin in the outpatient setting.
Adverse events in community care: implications for practice, policy and research. [2019]Adverse events in community care constitute a system-wide issue that warrants attention from all healthcare system stakeholders. Improving patient safety and preventing adverse events will require policy at multiple levels that addresses (1) local healthcare system integration, (2) competition and financing, (3) technology and electronic records, (4) collaboration and communication among providers, (5) organizational culture and (6) education for clinicians, patients and caregivers. This article describes the results of a symposium in which 31 healthcare professionals from 18 organizations were asked to discuss adverse events and to identify important implications for practice, policy and research. Results include prioritized lists of what providers can do to prevent adverse events, suggested policy changes and information needed from research.
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]Age is one of the most important risk factors in the development of diabetes mellitus and certain drug classes indicated for this condition may be associated with clinically important adverse drug reactions (ADRs). The aim of this study was to analyze the suspected ADRs in older patients with diabetes mellitus, reported to the Portuguese Pharmacovigilance System from 2008 to 2018.
Diabetes Training for Community Health Workers. [2020]A 2.5-month diabetes education training for community health workers (CHWs) was developed, implemented, and evaluated.
Patients' Perspectives on the Feasibility, Acceptability, and Impact of a Community Health Worker Program: A Qualitative Study. [2021]Purpose: To examine patients' perceptions of the feasibility, acceptability, and impact of a safety net-based community health worker (CHW) program. Methods: Semistructured interviews with patient participants diagnosed with type 2 diabetes (n=13) were analyzed using a traditional text analysis method based on grounded theory. Results: This study highlights that the CHW program can improve satisfaction in accessing health services and community resources, and overall health outcomes of patients in safety net practices. Conclusion: Patients' overall positive perception of the CHW program suggests that the intervention may be a viable solution to address the health and social needs of patients in safety net settings.
Diabetes management: utilizing community health workers in a Hawaiian/Samoan population. [2022]Although not widely utilized, community health workers (CHWs) have been shown to enhance diabetes education and management efforts among racial/ethnic minority populations.
The role of community health workers in combating type 2 diabetes in the rio grande valley. [2013]The purpose of this study was to determine the effectiveness of the use of community health workers (CHWs, aka promotoras de salud in Spanish) in the control of type 2 diabetes (diabetes mellitus) in the Rio Grande Valley (RGV). Known from the literature as "a disease of the 21st century" and being the third leading cause of death in the United States, type 2 diabetes is a very common disease in the RGV because of its predominantly Mexican American population, a group genetically vulnerable to the disease. Unlike prior studies that examined the overall effectiveness of the CHW model, the authors used registered CHWs as primary diabetes educators. Another innovation of this study was the authors monitored a wide range of biologic (HbA1c and body mass index [BMI]) and behavioral (diabetes knowledge, self-efficacy, self-management activities scores) outcomes. The research hypothesis was that the educational service provided by CHWs to the diabetic patients would assist them in controlling their disease. The design of the study was experimental. The target population consisted of Mexican American adults from RGV diagnosed with type 2 diabetes and willing to participate. The intervention group received monthly visits from CHWs. The results showed a significant improvement after one year of intervention in all outcomes, except BMI, in the experimental group.
Applying the community health worker model to diabetes management: using mixed methods to assess implementation and effectiveness. [2011]The community health worker (CHW) model is a popular method for reaching vulnerable populations with diabetes. This study assessed implementation and effectiveness of the model within diabetes programs.