Evaluating Telementoring for CHW-centered Diabetes Initiatives

NCT04835493 | Active Not Recruiting DMC

• 2 other identifiers: 22-0224R01DK129474
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes care is complex and requires a multidimensional approach, but interventional programs are difficult to initiate in low-income and minority populations. In the proposed study, investigators will mentor local clinics via telehealth to initiate our diabetes program involving telehealth-support, integrated CHWs, medication-access, and diabetes Education into their clinics. Mentoring local clinics to initiate this intervention is a promising strategy to enhance sustainable diabetes care and reduce disparities in vulnerable minority populations.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Compare intervention versus control HbA1c levels

  Baseline to 12-months

Secondary Outcomes (16)

• Blood pressure

  Baseline to 12-months

• Body Mass Index (BMI)

  Baseline to 12-months

• Cholesterol

  Baseline to 12-months

• American Diabetes Association (ADA) adherence measures: Diabetes foot exam

  Baseline to 12-months

• ADA adherence measures: B12 screening

  Baseline to 12-months

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention individuals will receive the 12-month diabetes program

Other: Intervention

Usual Care (UC)

OTHER

We will define UC as usual clinical care, which consists of diabetes management provider encounters (mean quarterly) plus monthly individual appointments with a pharm-Ds or nutritionists as clinically indicated. In addition, clinics offer multiple other individual and group opportunities.

Other: Intervention

Interventions

Intervention OTHER

In the proposed study, we will conduct a randomized clinical trial of low-income, adult Latino(a)s with type 2 diabetes randomized at the individual level a telehealth-supported, integrated CHWs, medication-access, diabetes education program) (intervention) versus usual care (UC). Our research team will provide telementoring to local clinic teams (providers and CHWs) to initiate the 12-month the program into their clinics.

Intervention; Usual Care (UC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identified Latino(a)
• Spanish-speaking
• \>/=18 years
• type 2 diabetes (T2D), e.g., HbA1c \>/=6.5%, provider documented T2D, on oral anti-hyperglycemic
• uninsured, \<150% federal poverty level

You may not qualify if:

• no show to all group visits
• condition that may alter HbA1c levels, e.g., recent blood transfusion
• patients at high-risk or not appropriate for care in a group setting e.g., pregnancy, severe cognitive impairment, frequent clinic appointments for labile glucose/medication titration e.g., insulin.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: collaborator
• The University of Texas Medical Branch, Galveston: lead
• University of Houston: collaborator
• Baylor College of Medicine: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Texas Medical Branch

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Ameri M, Jabbar LA, Kim S, Raji M, Samson SL, Vaughan EM. Training clinicians to facilitate diabetes group visits. BMC Med Educ. 2025 Feb 25;25(1):309. doi: 10.1186/s12909-025-06876-7.

  PMID: 40001087 DERIVED

• Porterfield L, Warren V, Schick V, Gulliot-Wright S, Temple JR, Vaughan EM. Addressing Training Gaps: A Competency-Based, Telehealth Training Initiative for Community Health Workers. Telemed Rep. 2023 Jun 16;4(1):126-134. doi: 10.1089/tmr.2023.0007. eCollection 2023.

  PMID: 37351464 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Elizabeth Vaughan, DO

  UTMB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 1. Randomization will be achieved by blinded study staff using an automatic number generator that allows for stratification and blocking. 2. Individuals entering and obtaining study data will be blinded to study arm 3. Data will be collected prior to randomization for blinding purposes. Month-12 clinical data will be obtained in-person for both arms by nurses blinded to the study arm e.g., different nurses than those in the group visits, and chart review will be conducted for ADA measurements and for other clinical data if individuals from either study arm do not show. 4. Blinded research assistants will gather HbA1c, blood pressure, cholesterol, and BMI data for both arms quarterly until 36-months from baseline.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: September 1, 2022
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)