Technology to Improve the Health of Resource-poor Hispanics With Diabetes
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Baylor College of Medicine
- Enrollment
- 265
- Locations
- 1
- Primary Endpoint
- Glycemic control
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Elizabeth Vaughan
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
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
Outcomes
Primary Outcomes
Glycemic control
Time Frame: At baseline and every 6-months until study completion
Hemoglobin A1c (%)
Secondary Outcomes
- Survey(at the beginning and end of each cohort (baseline, six-months))
- Body Mass Index (BMI)(At baseline and every 6-month until study completion)
- Diabetes-related health(at the beginning and end of each cohort (baseline, six-months))
- Blood Pressure(At baseline and every 6-month until study completion)
- Barriers to care(weekly to bimonthly from baseline to 12-months)
- Adherence to preventive care guidelines(pre/post diabetes group visits)
- longitudinal outcomes(from the time group visits end and as long as month-24 after)