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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: diabetes program
* Other: telehealth training and support for Community Health Workers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Receive diabetes group visits/diabetes program | Other: diabetes program<br>* Comprehensive diabetes program (weekly to bimonthly CHW mHealth contact (phone, text) for 12-months and monthly diabetes group visits for 6-months)<br>Other: telehealth training and support for Community Health Workers<br>* weekly 1-hour diabetes training and patient support for CHWs via telehealth i.e., ZOOM technology for the study duration<br>|
| No Intervention: Control<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Hemoglobin A1c (%) | At baseline and every 6-months until study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to preventive care guidelines | 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. | pre/post diabetes group visits | 
| Survey | 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. | at the beginning and end of each cohort (baseline, six-months) | 
| Diabetes-related health | 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) | at the beginning and end of each cohort (baseline, six-months) | 
| Body Mass Index (BMI) | Body Mass Index (BMI) (weight in kg/height in m^2) | At baseline and every 6-month until study completion | 
| Blood Pressure | Blood Pressure (mmHg) | At baseline and every 6-month until study completion | 
| Barriers to care | 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. | weekly to bimonthly from baseline to 12-months | 
| longitudinal outcomes | conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including blood pressure (mmHg) | from the time group visits end and as long as month-24 after | 
| longitudinal outcomes | conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including HbA1c (%) | from the time group visits end and as long as month-24 after | 
| longitudinal outcomes | conduct a chart review to determine long-term (until 24-months post group visits) clinical outcomes including BMI (kg/m^2) | from the time group visits end and as long as month-24 after |