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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new text message tool designed to help Latino adults with type 2 diabetes adhere to their medication regimen. The tool sends daily messages about diet, exercise, and medication reminders, along with weekly feedback on medication-taking habits. Participants may be a good fit if they have type 2 diabetes, have struggled with regular medication adherence, and prefer receiving messages in Spanish. This tool could simplify diabetes management and reduce complications for Latino adults in the U.S. As an unphased trial, the study offers a unique opportunity to contribute to innovative solutions for diabetes management.

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 prior data suggests that this digital health tool is safe for improving medication adherence in diabetes?

Research shows that the REACH-Es digital health tool, which uses text messages to assist people in taking their diabetes medication, has been well-received by adults with type 2 diabetes from various backgrounds. Studies indicate that participants responded positively to the text messages, which helped them manage their diabetes better without any major side effects. This suggests the tool is safe for people with diabetes.

The Enhanced Treatment as Usual (ETAU) approach includes standard medical care, which remains safe as it follows established medical guidelines. Adding occasional informative text messages is unlikely to cause any safety issues.

Overall, both REACH-Es and ETAU aim to help manage diabetes without introducing significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they aim to enhance medication adherence in diabetes, a critical aspect of effective disease management. Unlike traditional diabetes treatments that focus solely on medication and physician monitoring, the REACH-Es tool uniquely integrates technology by using daily SMS messages to provide personalized information and feedback on diet, exercise, and medication adherence. This includes interactive two-way messaging to engage participants actively in their care. The Enhanced Treatment as Usual (ETAU) also introduces digital elements by providing patients with updates and educational content via SMS, promoting better self-care. These innovations have the potential to improve how patients stick to their treatment plans, potentially leading to better health outcomes.

What evidence suggests that this digital health tool is effective for improving medication adherence in diabetes?

Research shows that the REACH-Es tool, which participants in this trial may receive, uses text messages to help people with diabetes take their medicines more regularly. Studies on similar text messaging tools have found that they can help people remember to take their medication more often. This is especially important for Latino individuals who face more challenges in managing diabetes. The REACH-Es system sends daily messages about diet, exercise, and medicine, along with regular updates on blood sugar levels. This approach aims to make it easier for people to manage their diabetes and reduce complications. Participants in the Enhanced Treatment As Usual (ETAU) arm will continue their usual care with additional educational messages and updates. ^{2 3 6 7 8}

Who Is on the Research Team?

Jacqueline Seiglie

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12061353/

Adapting a Text Messaging Intervention to Improve Diabetes ... This study aimed to report the multiphase, stakeholder-driven adaptation of the REACH barriers to diabetes medication adherence content to a Latino population.

2. researchgate.net researchgate.net/figure/Rapid-Education-Encouragement-And-Communications-for-Health-REACH-experience-for-a_fig1_307950137

Rapid Education/Encouragement And Communications for ... Conclusions This review highlights critical factors influencing the design of SMS text messaging interventions for medication adherence in the management of ...

3. massgeneral.trialstoday.org massgeneral.trialstoday.org/trial/NCT06000813

Mass General - Division of Clinical Research The goal of REACH-Español is to improve diabetes medication adherence ... One such mHealth platform is REACH (Rapid Encouragement/Education And Communications for ...

4. withpower.com withpower.com/trial/phase-diabetes-mellitus-2024-36ac2

Digital Health Tool for Improving Medication Adherence in ... ETAU, REACH-Es is unique because it integrates digital health tools to provide tailored education and reminders, which can help improve medication adherence in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40311126/

Adapting a Text Messaging Intervention to Improve Diabetes ... This study aimed to report the multiphase, stakeholder-driven adaptation of the REACH barriers to diabetes medication adherence content to a Latino population.

6. memotext.com memotext.com/wp-content/uploads/2022/04/Nelson_Mayberry-Reach-Program-MOVES-Slides.pdf

The REACH Program The REACH Study had excellent long-term retention and intervention engagement among diverse adults with type 2 diabetes. • REACH improved clinical and ...

7. researchgate.net researchgate.net/publication/389808716_Adapting_a_text_messaging_intervention_to_improve_diabetes_medication_adherence_in_a_Spanish-speaking_population_A_qualitative_study_Preprint

Adapting a text messaging intervention to improve diabetes ... Objective This study aimed to report the multiphase, stakeholder-driven adaptation of the REACH barriers to diabetes medication adherence ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33154039/

Effects of a Tailored Text Messaging Intervention Among ... REACH engaged at-risk patients in diabetes self-management and improved short-term HbA 1c . More than texts alone may be needed to sustain the effects.