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Completed

NCT Number: NCT06000813

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Diabetes Research Center

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

REACH-Es

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.

Other names: REACH-Español

ETAU

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.

Primary outcomes

  1. Feasibility (recruitment rate)

    Time frame: Collected at 0 months

    Number of eligible participants who enroll/ Number of eligible participants who are contacted and reached by phone

  2. Feasibility (response rate to 2-way text messages)

    Time frame: Collected at 3 and 6 months

    Number of 2-way text messages answered/ Number of 2-way text messages received

  3. Feasibility (retention rate)

    Time frame: Collected at 3 and 6 months

    Number of participants enrolled in the study at follow-up/ Number of participants enrolled at the start of the study

  4. Acceptability

    Time frame: Collected at 3 and 6 months

    Assessed quantitatively based on utility of REACH-Es on a 0-10 Likert scale and qualitatively through exit interviews.

  5. Usability

    Time frame: Collected at 3 and 6 months

    Assessed quantitatively by administering the 10-item Spanish version of the System Usability Scale (SUS) questionnaire, scored on a 0-5 Likert-type scale.

  6. Diabetes Medication adherence

    Time frame: Collected at 0, 3, and 6 months

    Assessed using the 11-item Adherence to Refill and Medication Scale (ARMS-d) questionnaire scored on a 0-4 Likert scale (range 12-48).

  7. IMB barrier sum score

    Time frame: Collected at 0, 3, and 6 months

    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).

Secondary outcomes

  1. HbA1c

    Time frame: Collected at 0, 3, and 6 months

    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.

  2. Diabetes self-efficacy

    Time frame: Collected at 0, 3, and 6 months

    Assessed by administering the 8-item Spanish Diabetes Self-Efficacy questionnaire (0-10 Likert scale).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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