NCT06000813

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jun 2024Feb 2027

First Submitted

Initial submission to the registry

August 4, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

June 18, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

2.5 years

First QC Date

August 4, 2023

Last Update Submit

October 20, 2025

Conditions

Type 2 Diabetes (Adult Onset)Medication Adherence

Keywords

Type 2 diabetesMedication adherenceMobile healthLatino adults

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (2)

  • HbA1c

    Collected at 0, 3, and 6 months

  • Diabetes self-efficacy

    Collected at 0, 3, and 6 months

Study Arms (2)

REACH-Es

EXPERIMENTAL

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

Enhanced treatment as usual (ETAU)

ACTIVE COMPARATOR

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

Interventions

REACH-EsBEHAVIORAL

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.

Also known as: REACH-Español
REACH-Es
ETAUBEHAVIORAL

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.

Enhanced treatment as usual (ETAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Auditory limitations and/or inability to communicate orally
  • Inability to receive, read, or send a text message (assessed by a trained research assistant)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Diabetes Research Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jacqueline Seiglie

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 21, 2023

Study Start

June 18, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data requests can be made 12 months after manuscript publication and will be made available for up to 24 months.
Access Criteria
Access to the data will be contingent on review and approval of a research proposal and Statistical Analysis Plan.

Locations

US(1)