Care Navigator Support for Type 2 Diabetes

(AURORA Trial)

Overseen By Amy Valdati

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Pregnancy, Type 1 diabetes

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 months

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new care strategy called AURORA to assist Latinx individuals recently diagnosed with Type 2 Diabetes. The study will determine if a care navigator (a person who coordinates healthcare services) improves diabetes management compared to usual care. It targets individuals diagnosed with Type 2 Diabetes in the past 1-8 months who have higher blood sugar levels (HbA1c of 8% or more). Participants should speak English or Spanish and be members of Kaiser Permanente Northern California. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes care strategies.

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 the AURORA Care Strategy is safe for younger-onset Latinx individuals with Type 2 Diabetes?

Research shows that the AURORA Care Strategy is a new method designed to help Latinx individuals with early-onset type 2 diabetes. Although specific safety data for this approach is unavailable, it focuses on support through care navigators. This includes personalized telemedicine visits, which are generally safe because they don't involve medications or surgeries.

The trial phase is labeled "Not Applicable," indicating that the study doesn't primarily test safety like drug trials. Instead, it evaluates the effectiveness of the care strategy, suggesting it is likely well-tolerated. For safety concerns, speaking with the trial coordinators can provide more personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AURORA Care Strategy for type 2 diabetes because it offers a novel approach to patient support. Unlike standard treatments that primarily focus on medication and lifestyle changes, this strategy adds an extra layer of personalized care through a care navigator. This navigator helps patients manage their condition more effectively by providing tailored guidance and support, potentially improving adherence to treatment plans and overall health outcomes. The hope is that this personalized approach will lead to better diabetes management and enhance patients' quality of life.

What evidence suggests that the AURORA Care Strategy is effective for Type 2 Diabetes?

Research has shown that care navigator strategies, such as the AURORA Care Strategy, can help manage Type 2 Diabetes, particularly in Latinx communities. Early findings suggest that patient navigators, who provide culturally sensitive support and education, improve health outcomes. This approach includes personalized telemedicine visits, making diabetes management more accessible from the start. These strategies aim to boost patient involvement and adherence to treatment plans, potentially leading to better blood sugar control. Although the AURORA strategy is still under study in this trial, early signs are promising for this type of targeted intervention. ^{1 2 3 5 6}

Who Is on the Research Team?

Anjali Gopalan, MD, MS

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for younger Latinx adults aged between 20 and 45 who are members of Kaiser Permanente Northern California, have been newly diagnosed with Type 2 Diabetes in the last 1-8 months, and have an HbA1c level of at least 8%. They must be proficient in English or Spanish. Pregnant women and individuals with Type 1 Diabetes cannot participate.

Inclusion Criteria

I am between 21 and 44 years old, recently diagnosed with Type 2 Diabetes, and my HbA1c is at least 8%.

I can communicate well in English or Spanish.

Exclusion Criteria

Pregnant women

I have Type 1 Diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AURORA Care Strategy, including three telemedicine visits tailored to Latinx adults with early onset type 2 diabetes

3 months

3 visits (telemedicine)

Follow-up

Participants are monitored for changes in HbA1c and other diabetes-related outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• AURORA Care Strategy

Trial Overview The AURORA Care Strategy is being tested to see if a culturally responsive care navigator can help young Latinx adults manage their new diagnosis of Type 2 Diabetes more effectively within the healthcare system provided by Kaiser Permanente Northern California.

How Is the Trial Designed?

Group I: AURORA Care Strategy Experimental Treatment 1 Intervention

Participants will receive the AURORA Care Strategy in addition to their usual diabetes care.

Group II: Usual Care Active Control 1 Intervention

No intervention will be employed. This arm will continue to receive their usual diabetes care.

AURORA Care Strategy is already approved in United States for the following indications:

Approved in United States as AURORA Care Strategy for:

• Type 2 Diabetes management in younger-onset Latinx individuals

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Published Research Related to This Trial

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]

Adverse drug events (ADEs) are a major cause of preventable harm in hospitals, particularly affecting older adults, prompting the creation of a National Action Plan to enhance medication safety.

The Action Plan focuses on preventing ADEs from three high-risk medication classes: anticoagulants, diabetes agents, and opioids, and emphasizes surveillance, evidence-based prevention, and education for both healthcare providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Medication Safety: Establishing a National Action Plan for Adverse Drug Event Prevention. Harris, Y., Hu, DJ., Lee, C., et al.[2019]

Implementing volunteer bilingual navigation in a children's multispecialty clinic led to a non-significant decrease in appointment no-shows, suggesting it may help improve attendance for monolingual Spanish-speaking families.

Patient satisfaction ratings increased from 84.0 to 92.9 during the intervention, indicating that bilingual navigation could enhance the overall experience for Spanish-speaking families, even though the increase was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Satisfaction and Appointment Attendance Through Navigation for Spanish-Speaking Families. Flower, KB., Wurzelmann, S., Rojas, C., et al.[2021]

A systematic review of 12 quantitative studies identified key barriers to healthcare access for Hispanics with type 2 diabetes, including self-care behaviors, individual resources like cost, and a lack of specialized providers.

The majority of barriers were self-related (92%), indicating that personal factors such as diet and exercise significantly impact access to care, while provider-related (50%) and environmental factors (25%) also play a role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Barriers to Access-to-Care in Hispanics With Type 2 Diabetes. Titus, SK., Kataoka-Yahiro, M.[2021]

A 27-week automated telephone self-management support program for diabetes significantly improved self-care behaviors and physical health scores among linguistically diverse patients, with effect sizes of 0.29 and 0.25 respectively.

The intervention was effective for English, Spanish, and Cantonese speakers, suggesting that automated telephone support can enhance diabetes management in low-income populations, although it did not significantly impact patient-centered care processes or cardiometabolic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes health information technology innovation to improve quality of life for health plan members in urban safety net. Ratanawongsa, N., Handley, MA., Sarkar, U., et al.[2022]

Culturally tailored diabetes self-management education (DSME) effectively improves glycemic control and health outcomes in Mexican Americans, as shown in a study with 165 participants in a rural Texas community.

Adding a nurse case manager (NCM) to the DSME program increased attendance rates, although both groups showed similar improvements in diet, physical activity, and clinical outcomes, indicating the need for further research on the NCM's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating education, group support, and case management for diabetic Hispanics. Brown, SA., García, AA., Winter, M., et al.[2021]

In a study of 27,542 patients with diabetes, Hispanic patients were found to have higher HbA1c levels compared to other racial/ethnic groups, indicating poorer diabetes control.

While medication adherence (measured by the proportion of days covered) was negatively associated with HbA1c levels, the disparity in HbA1c levels among Hispanic patients persisted, suggesting that other factors beyond medication adherence may contribute to these differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Relationship Between Medication Adherence and Diabetes Disparities among Hispanic Patients in a Large Health System. Narain, KDC., Patel, A., Skootsky, S., et al.[2023]

The Patient Navigator Program at NewYork-Presbyterian Queens successfully supported 30,164 patients from February 2020 to December 2022, significantly improving follow-up appointment attendance, with 81% of patients attending their scheduled appointments.

The program demonstrated that Patient Navigators, who provide culturally sensitive education and support, can effectively help patients without primary care providers establish new care connections, as 94% of these patients secured a new provider upon discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency department patient navigators successfully connect patients to care within a rapidly evolving healthcare system. Peretz, PJ., Vargas, H., D'urso, M., et al.[2023]

The DIALBEST trial demonstrated that a community health worker (CHW)-led intervention significantly improved glycemic control in 211 Latino adults with poorly controlled type 2 diabetes (T2D), with notable reductions in HbA1c levels over 18 months.

Participants receiving the CHW intervention showed consistent improvements in HbA1c at multiple time points (3, 6, 12, and 18 months), indicating the effectiveness of structured support in managing diabetes, although there were no significant changes in blood lipid levels, hypertension, or weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a community health workers-led structured program on blood glucose control among latinos with type 2 diabetes: the DIALBEST trial. Pérez-Escamilla, R., Damio, G., Chhabra, J., et al.[2022]

A culturally tailored, integrated care intervention for low-income, Spanish-speaking Latinos with type 2 diabetes significantly improved HbA1c levels over 6 months, showing a greater reduction compared to usual care (ΔHbA1c = -0.35 vs. ΔHbA1c = -0.02).

The intervention also led to improvements in total cholesterol and diastolic blood pressure, indicating that this model of care can effectively support diabetes management and self-care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos with diabetes. Talavera, GA., Castañeda, SF., Mendoza, PM., et al.[2022]

Limited English proficiency (LEP) among US Latinos with diabetes is linked to poorer glycemic control, particularly when patients have language-discordant physicians, as shown in a study of 3,688 patients.

LEP Latinos with language-concordant physicians had similar odds of poor glycemic control as English-speaking Latinos, suggesting that improving language concordance in healthcare could help reduce health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Language barriers, physician-patient language concordance, and glycemic control among insured Latinos with diabetes: the Diabetes Study of Northern California (DISTANCE). Fernandez, A., Schillinger, D., Warton, EM., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-diabetes-mellitus-2-2023-ba6cf

Care Navigator Support for Type 2 Diabetes (AURORA Trial) The AURORA Care Strategy is unique because it uses patient navigators to provide culturally sensitive support and education, helping younger Latinx patients ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05754008/care-navigator-support-for-younger-latinx-adults-with-type-2-diabetes

Care Navigator Support for Younger Latinx Adults With ... The AURORA strategy centers on a care navigator who will proactively conduct three telemedicine visits tailored to Latinx adults with early ...

3. divisionofresearch.kaiserpermanente.org divisionofresearch.kaiserpermanente.org/research/health-care-delivery-and-policy/health-care-delivery-and-policy-studies/

Health Care Delivery and Policy Studies Our goal is to evaluate the effectiveness of a proactive, tailored care intervention in improving early outcomes for Latinx individuals with younger-onset type ...

4. reporter.nih.gov reporter.nih.gov/project-details/8467924

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

5. policylab.us policylab.us/clinical-trials/l/california/condition/type-2-diabetes?page=5

California Type 2 Diabetes Paid Clinical Trials & Research Studies ... The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and type II diabetes outcomes in type ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9888733/

Barriers in Healthcare for Latinx Patients with Limited ... Several studies have evaluated the experience of Latinx patients with LEP and how it influences health outcomes.