REACH-Es: Adapting a Digital Health Tool to Improve Diabetes Medication Adherence Among Latino Adults

Study Overview
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Brief Summary
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Latino individuals, the fastest growing ethnic minority population in the United States, have a higher prevalence of type 2 diabetes and diabetes-related complications, and are more likely to report inconsistent use of diabetes medications than non-Hispanic White individuals. The proposed project will test an interactive text message-based tool tailored to address barriers to taking diabetes medications that are relevant to Latino adults. If found feasible, acceptable, and usable, this intervention could serve as a scalable tool to improve diabetes management and reduce diabetes-related complications among Latino adults in the United States.

Detailed Description
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Latino adults have a disproportionate burden of type 2 diabetes and diabetes-related complications. Diabetes medication non-adherence is an important modifiable contributor to suboptimal glycemic management among Latino adults, who are nearly twice as likely to report non-adherence to diabetes medications as non-Hispanic White individuals. Besides language barriers, additional commonly reported barriers that contribute to non-adherence in this population include negative perceptions about insulin use and misunderstanding ongoing need for diabetes medications once HbA1c has improved. Mobile health (mHealth) technology can reduce medication adherence barriers and improve adherence behavior, but mHealth tools that address commonly reported barriers to diabetes medication adherence among Latino adults are lacking. One such mHealth platform is REACH (Rapid Encouragement/Education And Communications for Health), a text message-based tool that improved diabetes medication adherence and glycemic control among English-speaking adults with type 2 diabetes. This study will evaluate REACH-Español (hereafter REACH-Es), an mHealth platform adapted from the original REACH intervention that will incorporate qualitative input from Latino adults with type 2 diabetes on barriers to diabetes medication adherence relevant to this population. Specifically, the investigators will conduct a pilot RCT (n=70) to assess feasibility, acceptability, and usability of REACH-Es, as well as intervention targets (diabetes medication adherence and barriers to adherence) comparing REACH-Es to enhanced treatment as usual; secondary outcomes are HbA1c and diabetes self- efficacy. The project will generate preliminary data for an R01 hybrid-effectiveness implementation trial of REACH-Es.

Official Title
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REACH-Es: Adapting a Digital Health Tool to Improve Diabetes Medication Adherence Among Latino Adults

Conditions
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Type 2 Diabetes (Adult Onset), Medication Adherence

Intervention / Treatment
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* Behavioral: REACH-Es
* Behavioral: ETAU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus Have current or prior (since 2018) HbA1c ≥8.0% Take at least one diabetes medication Receive care at MGH- affiliated primary care practices (≥2 visits in the past 3 years) ≥18 yrs Identify as Latino and/or Hispanic Speak and read in Spanish as preferred language Willing and able to provide informed consent Access to a mobile telephone with text messaging capability Suboptimal diabetes medication adherence, assessed using the first 2 items in the Adherence to Refill and Medication Scale (ARMS-d) questionnaire combined: How frequently do you forget or decide to not take your diabetes medications? Participants who answer sometimes, almost always, and/or always will be considered eligible for the study. Exclusion Criteria: Auditory limitations and/or inability to communicate orally Inability to receive, read, or send a text message (assessed by a trained research assistant)

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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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REACH-Es<br>Participants in the REACH-Es arm will receive REACH-Es short message service (SMS), as follows: 1) Daily SMS (information related to diet, exercise, self-monitoring of blood glucose, their specific diabetes medication(s), and top 4 medication adherence barriers); 2) Daily two-way SMS (diabetes medication adherence question); 3) Weekly one-way SMS (participants receive weekly feedback on Sunday regarding how many of the last 7 days they took their medicine); 4) A SMS each time an HbA1c is collected with a link to a secure website that displays the result. | Behavioral: REACH-Es<br>* REACH-Español is a mobile health platform adapted from the original REACH intervention to a Latino population with type 2 diabetes. The goal of REACH-Español is to improve diabetes medication adherence and glycemic management in this population.<br>* Other names: REACH-Español;|
| Active Comparator: Enhanced treatment as usual (ETAU)<br>Participants will maintain care as usual (medication treatment and physician monitoring) in addition to a welcome SMS following enrollment, a SMS each time an HbA1c is collected with a link to a secure website that displays the result, and bi-monthly information on diabetes self-care education. | Behavioral: ETAU<br>* Participants will maintain care as usual (medication treatment and physician monitoring) in addition to a welcome SMS following enrollment, a SMS each time an HbA1c is collected with a link to a secure website that displays the result, and bi-monthly information on diabetes self-care education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (recruitment rate) | Number of eligible participants who enroll/ Number of eligible participants who are contacted and reached by phone | Collected at 0 months | 
| Feasibility (response rate to 2-way text messages) | Number of 2-way text messages answered/ Number of 2-way text messages received | Collected at 3 and 6 months | 
| Feasibility (retention rate) | Number of participants enrolled in the study at follow-up/ Number of participants enrolled at the start of the study | Collected at 3 and 6 months | 
| Acceptability | Assessed quantitatively based on utility of REACH-Es on a 0-10 Likert scale and qualitatively through exit interviews. | Collected at 3 and 6 months | 
| Usability | Assessed quantitatively by administering the 10-item Spanish version of the System Usability Scale (SUS) questionnaire, scored on a 0-5 Likert-type scale. | Collected at 3 and 6 months | 
| Diabetes Medication adherence | Assessed using the 11-item Adherence to Refill and Medication Scale (ARMS-d) questionnaire scored on a 0-4 Likert scale (range 12-48). | Collected at 0, 3, and 6 months | 
| IMB barrier sum score | Calculated by rating each barrier item on a 0-10 scale (1=never to 10=a lot) and identifying each participant's 4 highest- scored barriers (range 4-40). | Collected at 0, 3, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | The HbA1c collection will be done through: 1) EHR review if available <3 weeks from the enrollment visit, 2) point-of-care testing; or) clinical lab draw. | Collected at 0, 3, and 6 months | 
| Diabetes self-efficacy | Assessed by administering the 8-item Spanish Diabetes Self-Efficacy questionnaire (0-10 Likert scale). | Collected at 0, 3, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Medication adherence, Mobile health, Latino adults