Digital Navigation for Type 2 Diabetes

Overseen By Jorge A Rodriguez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Critical illness, dementia, delirium, others

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

Compensation: Varies

Number of Visits: 1

Duration: During hospital admission

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether teaching Latino adults with type 2 diabetes to use digital tools can improve their health management after hospital discharge. Participants will either receive one-on-one training to use a patient portal and telehealth services (referred to as Digital Navigation) or receive an educational sheet. Researchers aim to determine if this training helps patients manage their care more effectively using digital resources. Eligible participants are Latino adults with type 2 diabetes who have been admitted to Brigham and Women's Hospital and speak English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance digital health management for Latino adults with type 2 diabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that digital navigation is safe for patients with type 2 diabetes?

Research has shown that digital navigation, which aids in using tools like patient portals and telehealth, is generally safe. Although specific safety data for digital navigation is lacking, studies on similar digital health tools indicate they are well-tolerated. Digital navigation is not a drug or medical treatment, so it lacks the side effects associated with medications. Instead, it involves learning to use online health resources, which is considered low-risk. This makes digital navigation a safe choice for those seeking to enhance their digital health skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about digital navigation for Type 2 Diabetes because it offers a personalized approach to managing the condition. Unlike the standard care, which typically includes educational sheets, digital navigation provides one-on-one support to help patients effectively use patient portals and telehealth services. This method empowers patients by enhancing their ability to manage their health digitally, potentially leading to better outcomes and greater convenience in their daily lives.

What evidence suggests that digital navigation is effective for type 2 diabetes?

Research shows that digital guidance helps patients use health technology, such as patient portals, more effectively. Studies have found that when patients learn to use these portals, they often manage their health better. In this trial, some participants will receive one-on-one digital navigation support to learn about the functions of the patient portal and telehealth. For Latino patients with type II diabetes, using patient portals can improve health and make healthcare more efficient. Programs with digital health guides have successfully boosted these patients' digital skills. This training facilitates communication with healthcare providers and adherence to care plans. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for self-identified Latino adults with type II diabetes, admitted to Brigham and Women's Hospital, who speak English or Spanish. It excludes those critically ill or with dementia/delirium that affects learning and consent.

Inclusion Criteria

Preferred language: English or Spanish

I am a Latino adult with type II diabetes.

Admitted to general medicine floors at Brigham and Women's Hospital

Exclusion Criteria

Critical illness

I do not have dementia or similar conditions that affect my understanding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive digital literacy training by a digital navigator focusing on patient portal functions

During hospital admission

1 visit (in-person)

Follow-up

Participants are monitored for their use of the patient portal and telehealth post-discharge

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Navigation

Trial Overview The study tests if digital literacy training by a navigator helps Latino patients use online health tools post-hospitalization. It compares the effectiveness of this training against standard educational materials.

How Is the Trial Designed?

Group I: Digital Navigation Experimental Treatment 1 Intervention

Patients in this arm will receive 1:1 digital navigation support which will teach them about the functions of the patient portal and telehealth.

Group II: Standard of Care Active Control 1 Intervention

Patients in this arm will receive the standard of care which will be an educational sheet.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A prototype electronic Global Trigger Tool was developed to improve the identification of adverse events in hospitals, addressing limitations of existing methods that rely on retroactive chart reviews.

Feedback from six health professionals highlighted the need for better tracking of adverse events and suggested features for a user-friendly interface, paving the way for integration into electronic health record systems to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Usability Testing of a System to Detect Adverse Events and Medical Mistakes. Blakeney, EA., Dardas, T., Zierler, BK., et al.[2023]

This study introduces an innovative augmented reality (AR) solution aimed at improving health literacy regarding antihypertensive medications in individuals with type 2 diabetes, addressing a significant gap where up to 40% of patients struggle with health literacy.

The study evaluates the effectiveness of this AR tool compared to usual care, with the hypothesis that participants using the AR solution will show greater improvements in health literacy, potentially leading to better management of hypertension and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel augmented reality solution for improving health literacy around antihypertensives in people living with type 2 diabetes mellitus: protocol of a technology evaluation study. Ahmadvand, A., Drennan, J., Burgess, J., et al.[2019]

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 IC-Health project successfully developed 9 massive open online courses (MOOCs) aimed at improving digital health literacy among people with diabetes, with positive feedback on the cocreation process from 28 participants.

Participants showed a significant improvement in their digital health literacy after using the MOOCs, indicating that these educational tools can effectively address communication barriers and enhance self-management skills in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cocreation of Massive Open Online Courses to Improve Digital Health Literacy in Diabetes: Pilot Mixed Methods Study. Alvarez-Perez, Y., Perestelo-Perez, L., Rivero-Santana, A., et al.[2022]

A new health navigation program called 'Fala-M@ano-COVID-19' was developed specifically for men during the COVID-19 pandemic, utilizing input from both patient and professional navigators to ensure it meets real needs.

The program was structured through a systematic development process that included problem mapping, needs assessment, and the creation of care plans, demonstrating a thorough approach to addressing health navigation challenges during the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Fala-M@no-COVID-19": technological development of a health navigation program for men during the pandemic. Santos, FSD., Braga, LCA., Santos, RVPDS., et al.[2023]

A study analyzing 82,353 patient incident reports in Finland from 2007-2016 found that nearly half of the reports were due to inadequate, missing, or incorrect patient information, highlighting significant documentation hazards that can harm patient safety.

Although serious adverse events related to documentation were rare, 18 cases resulted in serious harm, indicating a need for improved uniformity in documentation practices to enhance patient care and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Register-Based Research of Adverse Events Revealing Incomplete Records Threatening Patient Safety. Kinnunen, UM., Kivekäs, E., Palojoki, S., et al.[2020]

In a pilot program involving 28 participants with type 2 diabetes, digital literacy was found to be essential for effective self-management using mobile health (mHealth) tools.

Providing digital training and support significantly improved participants' engagement and sustainable use of mHealth applications, highlighting the importance of equipping patients with the necessary skills to manage their health effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Digital Engagement in the Self-Management of Type 2 Diabetes. Park, S., Burford, S., Nolan, C., et al.[2018]

A randomized clinical trial involving 48 insulin-dependent diabetes patients showed that a 12-week electronic education program significantly reduced hemoglobin A1C levels (p < 0.001) and low-density lipoprotein cholesterol (p < 0.002) in the intervention group.

The study suggests that electronic education can effectively improve metabolic control in diabetes patients, enhancing health outcomes and patient satisfaction while reducing the need for additional training personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of electronic education on metabolic control indicators in patients with diabetes who need insulin: a randomised clinical control trial. Moattari, M., Hashemi, M., Dabbaghmanesh, MH.[2022]

The My Diabetes Care (MDC) portal was rated as having above-average usability by participants, with a median System Usability Scale score of 78.8, indicating it is user-friendly for individuals managing diabetes.

Participants, including those with limited health literacy, reported improved understanding of their diabetes health data and increased patient activation after using MDC, suggesting it could effectively support diabetes self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The My Diabetes Care Patient Portal Intervention: Usability and Pre-Post Assessment. Martinez, W., Hackstadt, AJ., Hickson, GB., et al.[2022]

About 51.3% of consumers with chronic health conditions reported having navigational needs when seeking health information online, indicating a significant portion would benefit from assistance in finding reliable resources.

Participants with navigational needs tended to have lower eHealth literacy and sought a wider variety of health information, suggesting that targeted support could enhance their ability to manage their health effectively online.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer Use of "Dr Google": A Survey on Health Information-Seeking Behaviors and Navigational Needs. Lee, K., Hoti, K., Hughes, JD., et al.[2022]

A review of 23 studies on consumer health technologies for diabetes management highlighted the importance of usability in determining patient engagement and the effectiveness of these interventions.

The studies employed various methods to assess usability, but there is a need for standardized testing processes and published findings to better understand the success or failure of these technologies in supporting diabetes education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting a technology-based diabetes intervention ready for prime time: a review of usability testing studies. Lyles, CR., Sarkar, U., Osborn, CY.[2021]

Out of 9,000 patient safety reports analyzed from 2012 to 2017, 36% identified usability issues related to electronic health records (EHRs) that contributed to medication events, highlighting significant safety concerns in pediatric care.

Among the usability issues, the most frequent problems were related to system feedback and visual display, with improper dosing being the most common medication error, indicating critical areas for improvement in EHR design to enhance safety for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Electronic Health Record Usability And Safety Challenges In Pediatric Settings. Ratwani, RM., Savage, E., Will, A., et al.[2019]

The implementation of electronic health records (EHR) has introduced challenges in diabetes care, particularly for patients with limited health literacy and English proficiency, highlighting the need for safer medication prescribing practices.

Recommendations for improving patient safety include adopting standardized medication naming, enhancing communication with pharmacies, and conducting research on EHR practices in safety net healthcare systems to better serve diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Challenges of Electronic Health Records and Diabetes Electronic Prescribing: Implications for Safety Net Care for Diverse Populations. Ratanawongsa, N., Chan, LL., Fouts, MM., et al.[2021]

A survey of 848 Spanish nurses revealed that most believe reliable digital information can help reduce unnecessary patient consultations and that over half of their patients could benefit from online health resources.

Nurses identified older age and low educational levels of patients as major barriers to using digital tools, while training and user-friendly technology were seen as key enablers to enhance patient empowerment in health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurses' view of benefits, enablers and constraints to the use of digital health tools with patients: A cross-sectional study. Navarro Martínez, O., Igual García, J., Salcedo, VT.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06283992

Digital Health Navigation for Latino Patients With Type II ... The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer ...

2. withpower.com withpower.com/trial/digital-navigation-for-type-2-diabetes-9824f

Digital Navigation for Type 2 Diabetes Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10114024/

Digital healthcare equity in primary care - PubMed Central - NIH To address digital disparities in primary care, we implemented an integrated digital health navigator program supporting portal use among patients with type II ...

4. trialx.com trialx.com/clinical-trials/listings/287009/digital-health-navigation-for-latino-patients-with-type-ii-diabetes/

Digital Health Navigation for Latino Patients With Type II ... Overview. The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8459217/

The Impact of Digital Patient Portals on Health Outcomes ... The aim of this systematic review was to summarize evidence on the impact of patient portals on health outcomes and health care efficiency.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10899831/

Telehealth Technologies in Diabetes Self-management ... This review focuses on self-educational telehealth tools available for diabetes self-management, their advantages and disadvantages, and factors that need to ...