Trials / Active Not Recruiting
Active Not RecruitingNCT06000813
REACH-Es: Adapting a Digital Health Tool to Improve Diabetes Medication Adherence Among Latino Adults
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2024-06-18
- Primary completion
- 2026-12-30
- Completion
- 2027-02-28
- First posted
- 2023-08-21
- Last updated
- 2025-10-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06000813. Inclusion in this directory is not an endorsement.