Technology to Improve the Health of Resource-poor Hispanics With Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: diabetes programOther: telehealth training and support for Community Health Workers
- Registration Number
- NCT03394456
- Lead Sponsor
- Baylor College of Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 265
- Hispanic adults with diabetes, low-income (earn less than/equal to 250% federal poverty level)
- not able to understand Spanish, group visit is not appropriate for care i.e., need individualized care, pregnancy, etc
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention telehealth training and support for Community Health Workers Receive diabetes group visits/diabetes program Intervention diabetes program Receive diabetes group visits/diabetes program
- Primary Outcome Measures
Name Time Method Glycemic control At baseline and every 6-months until study completion Hemoglobin A1c (%)
- Secondary Outcome Measures
Name Time Method Body Mass Index (BMI) At baseline and every 6-month until study completion Body Mass Index (BMI) (weight in kg/height in m\^2)
Survey at the beginning and end of each cohort (baseline, six-months) The survey totaled 12 questions and assessed participant satisfaction, mental relaxation, faith/spirituality, and open-ended comments. Questions were ranked as followed: 1-3 (4-point Likert Scale), 4-7 (10-point Likert Scale), 8-11 (open-ended, descriptive), 12 (days of exercise/week). The Use of Mental Stress Management/Relaxation Techniques questionnaire and our pilot study survey templates were used to evaluate patient group visit and CHW satisfaction. We defined acceptability as high (3.5-4/4 or 8-10/10), moderate (2-3.4/4 or 4-7/10), and low (1-1.9/4 or 1-3/10) and totaled the items to create an overall score.
Diabetes-related health at the beginning and end of each cohort (baseline, six-months) As measured by the Self Management Resource Center Surveys: Diabetes Medications (a 4-question yes/no survey to assess patient medication adherence and understanding of their medications), Self-rated Health (a 1-question ranked on a 5-point scale (1 is excellent, 5 is poor) to determine the patient's view of their health)
Blood Pressure At baseline and every 6-month until study completion Blood Pressure (mmHg)
Barriers to care weekly to bimonthly from baseline to 12-months We obtain barriers to care data from the CHW-patient mobile health (mHealth) records and chart review, and group into three categories: obtaining medications, appointment access, clinic eligibility. mHealth records were sent to the study physician through a secure, encrypted site on a weekly basis.
Adherence to preventive care guidelines pre/post diabetes group visits As measured by placement on a statin, annual urine micro albumin, target A1c, weight loss (if applicable), retinal eye examination, blood pressure targets, serum B12 measurements, vaccinations.
longitudinal outcomes from the time group visits end and as long as month-24 after conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including BMI (kg/m\^2)
Trial Locations
- Locations (1)
Baylor College of Medicine
🇺🇸Houston, Texas, United States