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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06000813
• Other study ID #: 2023p001968
• Secondary ID: 1K23DK135798-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Jacqueline Seiglie
• Phone: 714-588-4791
• Email: jseiglie[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: February 28, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Medication Adherence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Diabetes Research Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (recruitment rate)	Number of eligible participants who enroll/ Number of eligible participants who are contacted and reached by phone	Collected at 0 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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