70 Participants Needed

Digital Health Tool for Improving Medication Adherence in Diabetes

JS
Overseen ByJacqueline Seiglie
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
Must be taking: Diabetes medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study focuses on improving adherence to diabetes medications, it seems likely that you will continue taking them.

What data supports the effectiveness of the treatment ETAU, Enhanced Treatment As Usual, Standard Care, Usual Care, REACH-Es, REACH-Es, Rapid Education/Encouragement and Communications for Health - Español for improving medication adherence in diabetes?

Research shows that tailored diabetes education and support programs, especially those using digital tools and personalized coaching, can improve diabetes management and medication adherence. These approaches have been effective in enhancing diabetes knowledge and health outcomes, particularly among Latino populations who face language and literacy barriers.12345

Is the digital health tool for improving medication adherence in diabetes safe for humans?

The research articles do not provide specific safety data for the digital health tool, but they suggest that similar health information technology tools have been used safely in educational interventions for diabetes management.13678

How is the treatment ETAU, REACH-Es unique for improving medication adherence in diabetes?

ETAU, REACH-Es is unique because it integrates digital health tools to provide tailored education and reminders, which can help improve medication adherence in diabetes patients by addressing individual barriers and supporting patient-centered decision-making.125910

Research Team

JS

Jacqueline Seiglie

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for Latino adults with type 2 diabetes who prefer to speak and read Spanish, have had suboptimal medication adherence, and an HbA1c level of ≥8.0% since 2018. Participants must be over 18, use a mobile phone with texting, and receive care at MGH-affiliated practices. Those with hearing issues or unable to handle text messages are excluded.

Inclusion Criteria

Your average blood sugar level, measured over the past few months, is 8.0% or higher.
Willing and able to provide informed consent
Receive care at MGH-affiliated primary care practices (≥2 visits in the past 3 years)
See 6 more

Exclusion Criteria

I have hearing difficulties or cannot speak.
Inability to receive, read, or send a text message (assessed by a trained research assistant)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the REACH-Es intervention, including daily and weekly SMS related to diabetes management and adherence

6 months
Daily SMS interactions, weekly feedback SMS

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • ETAU
  • REACH-Es
Trial Overview The study tests REACH-Es, a digital health tool delivering tailored interactive text messages designed to help Latino adults overcome barriers to taking their diabetes medications consistently.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: REACH-EsExperimental Treatment1 Intervention
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.
Group II: Enhanced treatment as usual (ETAU)Active Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

Latinos experience higher rates of diabetes and related complications, and existing health information technology (HIT) tools for diabetes management may not be effectively utilized by this group, especially those with low literacy or limited English proficiency.
The development of a novel 'eNavigator' role aims to enhance the adoption of HIT among Latinos, which could help improve diabetes self-management and reduce health care disparities.
Closing the gap: eliminating health care disparities among Latinos with diabetes using health information technology tools and patient navigators.López, L., Grant, RW.[2022]
A new electronic health record dashboard has been developed to help track diabetes medication adherence by integrating patient-reported barriers, which could improve clinical outcomes for the over 285 million people affected by diabetes worldwide.
The dashboard is currently being evaluated in multiple clinics to see if it can enhance patient-centered decision-making for managing complex diabetes medication regimens, addressing the common issue of poor adherence.
Improving medication adherence for chronic disease using integrated e-technologies.Dixon, BE., Jabour, AM., Phillips, EO., et al.[2013]
Participants in the Journey to Life Conversation Map Education Class significantly improved their hemoglobin A1c (HbA1c) levels, decreasing from an average of 8.25 to 6.96, compared to a smaller decrease in the control group from 8.57 to 8.27, indicating effective diabetes management education.
The class also led to a notable reduction in low-density lipoprotein (LDL) cholesterol levels, with attendees decreasing from 111 mg/dL to 94 mg/dL, while the comparison group saw an increase, highlighting the program's positive impact on cardiovascular risk factors.
Participation in the Journey to Life Conversation Map Improves Control of Hypertension, Diabetes, and Hypercholesterolemia.Crawford, P., Wiltz, S.[2015]

References

Closing the gap: eliminating health care disparities among Latinos with diabetes using health information technology tools and patient navigators. [2022]
Improving medication adherence for chronic disease using integrated e-technologies. [2013]
Participation in the Journey to Life Conversation Map Improves Control of Hypertension, Diabetes, and Hypercholesterolemia. [2015]
Influence of Supervised Disease Understanding and Diabetes Self-Management on Adherence to Oral Glucose-Lowering Treatment in Patients with Type 2 Diabetes. [2023]
Can digital health apps provide patients with support to promote structured diabetes education and ongoing self-management? A real-world evaluation of myDiabetes usage. [2023]
Impact of the «Conversation Map™» tools on understanding of diabetes by Spanish patients with type 2 diabetes mellitus: a randomized, comparative study. [2016]
Addressing low health literacy with "Talking Pill Bottles": A pilot study in a community pharmacy setting. [2018]
Evaluating the Impact of Mobile Phone Technology on Health Outcomes for Latinos with Type 2 Diabetes. [2021]
Cloud-based multi-media systems for patient education and adherence: a pilot study to explore patient compliance with colonoscopy procedure preparation. [2021]
System Architecture for "Support Through Mobile Messaging and Digital Health Technology for Diabetes" (SuMMiT-D): Design and Performance in Pilot and Randomized Controlled Feasibility Studies. [2021]
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