Technology to Improve the Health of Resource-poor Hispanics With Diabetes

Baylor College of Medicine

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: diabetes program; Other: telehealth training and support for Community Health Workers

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03394456

K23DK110341 (U.S. NIH Grant/Contract)

H-40322 (Other Identifier)

Details and patient eligibility

About

This study evaluates the efficacy and implementation of a telehealth-supported, integrated diabetes group visit program led by Community Health Workers (CHWs). Primary study relates to efficacy and a secondary study addresses mentored implementation.

Full description

The number of Hispanics diagnosed with diabetes is escalating in the US with disproportionately higher prevalence and complication rates than other ethnicities. CHWs are a well-established and culturally sensitive means to bridge gaps in care to individuals with diabetes. However CHWs are often left unsupported, placing patients at risk of substandard care or harm. Telehealth is a term used to describe a range of technologies to support healthcare delivery via communication with the patient or a member of the healthcare delivery team. Though telehealth has been implemented into diabetes programs for many years, there is a paucity of data showing the use of telemedicine for CHW training and support.

The primary study (n=89; Cohorts 1,2) compares clinical outcomes and treatment satisfaction of individuals who receive diabetes care in a 12-month telehealth supported, integrated CHW-led group visit program compared to those in usual care (wait list control). Group visits are 6-months and CHWs contact patients weekly to bimonthly (mobile health (mHealth)) for 12-months. This phase with have two cohort waves, separated by 6-months. The wait list control group for Cohort 2 will explore telehealth, clinician-patient encounters. A secondary study (n=59; Cohorts 3,4) at a new clinic evaluates the ability to implement the program. In the first phase of the secondary study the research team will conduct a RCT of individuals randomized to the diabetes program (intervention) vs usual care (control) to assess clinic feasibility. The clinic team will observe this process and learn the project protocols during Phase 1. In the second phase, the clinic team will lead the group visits while the research team mentors them to conduct the project in-person at the group visits and via telehealth each week (ZOOM video conferencing). Another secondary study (n=138; Cohort 5) aims to expand the reach of the education and CHW intervention for individuals who may not be able to or cannot come to the clinic for group visits. Specifically, individuals will received the education from the program monthly via a secure text message video, CHWs will contact weekly to bimonthly to advocate for their needs, and participants will receive their routine care as usual in the clinic.

Enrollment: 265 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Hispanic adults with diabetes, low-income (earn less than/equal to 250% federal poverty level)

Exclusion criteria

• not able to understand Spanish, group visit is not appropriate for care i.e., need individualized care, pregnancy, etc

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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265 participants in 2 patient groups

Intervention

Experimental group

Description:

Receive diabetes group visits/diabetes program

Treatment:

Other: diabetes program

Other: telehealth training and support for Community Health Workers

Control

No Intervention group

Description:

Receive usual care in the clinic, followed by group visits (wait list control) for cohorts 1-4 case-matched comparisons via chart review for cohort 5