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Type 2 Diabetes (Adult Onset)NCT06000813

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

A study testing REACH-Es and ETAU in people with Type 2 Diabetes (Adult Onset) and Medication Adherence, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
REACH-Es and ETAU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
18 Jun 2024to 27 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital Diabetes Research Center

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Read the 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.

Being tested
REACH-Es, ETAU
Keywords
Type 2 diabetes, Medication adherence, Mobile health, Latino adults
Medical subject headings
Diabetes Mellitus, Type 2, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REACH-EsBehavioural

    Also called REACH-Español

    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.

  • ETAUBehavioural

    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.

Study groups in NCT06000813
Study groupRoleWhat they receive
REACH-EsExperimentalParticipants 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.
Receives: Behavioral: REACH-Es
Enhanced treatment as usual (ETAU)Active comparatorParticipants 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.
Receives: Behavioral: ETAU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility (recruitment rate)

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

    Measured: Collected at 0 months

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

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

    Measured: Collected at 3 and 6 months

  3. Feasibility (retention rate)

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

    Measured: Collected at 3 and 6 months

  4. Acceptability

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

    Measured: Collected at 3 and 6 months

  5. 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.

    Measured: Collected at 3 and 6 months

  6. 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).

    Measured: Collected at 0, 3, and 6 months

  7. 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).

    Measured: Collected at 0, 3, and 6 months

Secondary outcomes (2)

  1. 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.

    Measured: Collected at 0, 3, and 6 months

  2. Diabetes self-efficacy

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

    Measured: Collected at 0, 3, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start18 Jun 2024
  3. Primary completion27 May 2026
  4. Study completion27 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06000813
Sponsor's protocol ID
2023p001968
Other IDs
1K23DK135798-01
Status last verified
Oct 2025
First submitted
4 Aug 2023
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing REACH-Es and ETAU in people with Type 2 Diabetes (Adult Onset) and Medication Adherence, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (recruitment rate) (time frame: Collected at 0 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06000813.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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