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

NCT ID: NCT06000813

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-18
• Study Completion Date: 2027-02-28

Brief Summary

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

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.

Conditions

Type 2 Diabetes (Adult Onset); Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

REACH-Es

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.

Group Type: EXPERIMENTAL

REACH-Es

Intervention Type: BEHAVIORAL

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.

Enhanced treatment as usual (ETAU)

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.

Group Type: ACTIVE_COMPARATOR

ETAU

Intervention Type: BEHAVIORAL

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.

Interventions

REACH-Es

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.

Intervention Type: BEHAVIORAL

ETAU

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

REACH-Español

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jacqueline A. Seiglie, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacqueline Seiglie

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Diabetes Research Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1K23DK135798-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023p001968

Identifier Type: -

Identifier Source: org_study_id