Clinical trial NCT06000813: REACH-Es: Adapting a Digital Health Tool to Improve Diabetes Medication Adherence Among Latino Adults
Official title: REACH-Es: Adapting a Digital Health Tool to Improve Diabetes Medication Adherence Among Latino Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes (Adult Onset)
Medication Adherence
Keywords: Type 2 diabetes
Medication adherence
Mobile health
Latino adults
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-08-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility (recruitment rate)
timeFrame: Collected at 0 months
measure: Feasibility (response rate to 2-way text messages)
timeFrame: Collected at 3 and 6 months
measure: Feasibility (retention rate)
timeFrame: Collected at 3 and 6 months
measure: Acceptability
timeFrame: Collected at 3 and 6 months
measure: Usability
timeFrame: Collected at 3 and 6 months
measure: Diabetes Medication adherence
timeFrame: Collected at 0, 3, and 6 months
measure: IMB barrier sum score
timeFrame: Collected at 0, 3, and 6 months
Secondary outcomes:
measure: HbA1c
timeFrame: Collected at 0, 3, and 6 months
measure: Diabetes self-efficacy
timeFrame: Collected at 0, 3, and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Diabetes Research Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jacqueline Seiglie
role: PRINCIPAL_INVESTIGATOR
References: