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.

Study Overview

• Status: Not yet recruiting
• Conditions: Medication Adherence; Type 2 Diabetes (Adult Onset)
• Intervention / Treatment: Behavioral: REACH-Es; Behavioral: ETAU

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacqueline Seiglie; Phone Number: 714-588-4791; Email: jseiglie@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Diabetes Research Center
      • Principal Investigator: Jacqueline Seiglie, MD
      • Sub-Investigator: Deborah Wexler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other Names: REACH-Español
Active Comparator: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jacqueline Seiglie, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Medication adherence; Mobile health; Latino adults
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2023p001968; 1K23DK135798-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified IPD can be requested by qualified investigators with interest in type 2 diabetes. Access to the data will be contingent on review and approval of a research proposal and Statistical Analysis Plan.
• IPD Sharing Time Frame: Data requests can be made 12 months after manuscript publication and will be made available for up to 24 months.
• IPD Sharing Access Criteria: Access to the data will be contingent on review and approval of a research proposal and Statistical Analysis Plan.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No