Digital Health Tool for Improving Medication Adherence in Diabetes

Overseen By Jacqueline Seiglie

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Diabetes medications

Disqualifiers: Auditory limitations, Inability to text, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

70 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 2 5 9 10}

Research Team

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)

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

Group I: REACH-Es Experimental Treatment 1 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 Control 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in the Journey to Life Conversation Map Improves Control of Hypertension, Diabetes, and Hypercholesterolemia. Crawford, P., Wiltz, S.[2015]

A systematic education program combined with telephone support significantly improved adherence to oral glucose-lowering treatment in patients with type 2 diabetes, with adherence rates increasing by 16.8% at 4 months and 18.8% at 8 months in the empowerment group compared to baseline.

Patients receiving the education and support also reported greater satisfaction with their treatment, as indicated by a significant increase in the Diabetes Treatment Satisfaction Questionnaire scores, highlighting the effectiveness of this approach in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Supervised Disease Understanding and Diabetes Self-Management on Adherence to Oral Glucose-Lowering Treatment in Patients with Type 2 Diabetes. Doupis, J., Alexandrides, T., Elisaf, M., et al.[2023]

The myDiabetes app, a digital health intervention, successfully activated nearly 50% of users referred by healthcare teams, indicating its potential to enhance diabetes education delivery.

Post-COVID-19, there was a significant increase in app usage, suggesting that digital health tools can effectively support diabetes self-management and may improve education rates when combined with traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can digital health apps provide patients with support to promote structured diabetes education and ongoing self-management? A real-world evaluation of myDiabetes usage. Blythin, AM., Elkes, J., van Lindholm, T., et al.[2023]

In a study involving 310 adults with type 2 diabetes, those who received Conversation Maps™ (CM) education showed significantly higher diabetes knowledge scores compared to those receiving regular care (RC) at both 2 and 6 months after the intervention (p<0.001).

While there were no significant differences in clinical outcomes between the two groups, the CM group reported higher satisfaction with care and a better perception of goal attainment, indicating that CM may enhance the educational experience for patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the «Conversation Map™» tools on understanding of diabetes by Spanish patients with type 2 diabetes mellitus: a randomized, comparative study. Penalba, M., Moreno, L., Cobo, A., et al.[2016]

The use of Talking Pill Bottles, which provide audio-assisted medication instructions, significantly improved blood pressure control among hypertensive patients with low health literacy, indicating a positive impact on health outcomes.

Patients showed high acceptance of the Talking Pill Bottle technology, suggesting it is a viable tool for enhancing medication adherence and understanding, although further research is needed to explore its effectiveness in newly diagnosed patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing low health literacy with "Talking Pill Bottles": A pilot study in a community pharmacy setting. Lam, AY., Nguyen, JK., Parks, JJ., et al.[2018]

A Spanish-language text messaging program significantly improved diabetes management in Latinos, resulting in a median HbA1c reduction of 1.4 percentage points after 3 months among 38 participants.

Participants with higher initial HbA1c levels (over 10.0%) experienced even greater reductions (3.8 percentage points), indicating that this intervention may be particularly beneficial for those with more severe diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Impact of Mobile Phone Technology on Health Outcomes for Latinos with Type 2 Diabetes. Jackson, LV., Carpenter, DM., Postlethwaite, DA., et al.[2021]

A cloud-based multimedia application was tested on 297 patients and showed a 43.4% relative improvement in adherence to endoscopy preparation procedures, indicating its potential effectiveness.

Involving healthcare providers in the design and evaluation of patient education applications may enhance their effectiveness and encourage wider adoption among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cloud-based multi-media systems for patient education and adherence: a pilot study to explore patient compliance with colonoscopy procedure preparation. Schooley, B., San Nicolas-Rocca, T., Burkhard, R.[2021]

The SuMMiT-D study successfully developed a tailored messaging system that delivered health interventions via SMS to over 250 participants with type 2 diabetes, showing low withdrawal rates of 4.2% and 5.3% in pilot and feasibility studies, respectively.

Participants reported positive feedback on the system's usability, indicating that regular SMS reminders could enhance engagement and potentially improve medication adherence and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chi, Y., Velardo, C., Allen, J., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Closing the gap: eliminating health care disparities among Latinos with diabetes using health information technology tools and patient navigators. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Improving medication adherence for chronic disease using integrated e-technologies. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Participation in the Journey to Life Conversation Map Improves Control of Hypertension, Diabetes, and Hypercholesterolemia. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Influence of Supervised Disease Understanding and Diabetes Self-Management on Adherence to Oral Glucose-Lowering Treatment in Patients with Type 2 Diabetes. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. Spain pubmed.ncbi.nlm.nih.gov

Impact of the «Conversation Map™» tools on understanding of diabetes by Spanish patients with type 2 diabetes mellitus: a randomized, comparative study. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Addressing low health literacy with "Talking Pill Bottles": A pilot study in a community pharmacy setting. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating the Impact of Mobile Phone Technology on Health Outcomes for Latinos with Type 2 Diabetes. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Cloud-based multi-media systems for patient education and adherence: a pilot study to explore patient compliance with colonoscopy procedure preparation. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

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]