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Care Navigator Support for Type 2 Diabetes (AURORA Trial)

N/A

Recruiting

Led By Anjali Gopalan, MD, MS

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Proficient (written and spoken) in English or Spanish

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months following enrollment

Awards & highlights

AURORA Trial Summary

This trial aims to help Latinx people newly diagnosed with Type 2 Diabetes by providing culturally-sensitive care navigation. #diabetes #care

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves a care strategy rather than medication, there may not be direct side effects like those associated with drugs. However, participants might experience stress or anxiety from changes in their healthcare routine.

AURORA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can communicate well in English or Spanish.

AURORA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months following enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months following enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months following enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Differences between study arms in HbA1c change 6-months following enrollment

Secondary outcome measures

Completion of recommended HbA1c monitoring

Healthcare contact

Participant-reported measures: Confidence in Accessing Care

+8 more

AURORA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AURORA Care StrategyExperimental Treatment1 Intervention

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

Group II: Usual CareActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,112,889 Total Patients Enrolled

Anjali Gopalan, MD, MSPrincipal InvestigatorKaiser Permanente

1 Previous Clinical Trials

817 Total Patients Enrolled

Media Library

AURORA Care Strategy Clinical Trial Eligibility Overview. Trial Name: NCT05754008 — N/A

Type 2 Diabetes Research Study Groups: AURORA Care Strategy, Usual Care

Type 2 Diabetes Clinical Trial 2023: AURORA Care Strategy Highlights & Side Effects. Trial Name: NCT05754008 — N/A

AURORA Care Strategy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05754008 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment number for this research endeavor?

"Yes, according to clinicaltrials.gov this study is still recruiting patients; it was initially published on March 31st 2023 and last modified a month later. A total of 204 participants are required from one medical site."

Answered by AI

Are additional participants being sought for this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that this clinical experiment is presently enlisting individuals, and was initially published on March 31st 2023 with a recent edit made April 25th 2023. The investigation needs 204 participants from 1 site to participate in the trial."

Answered by AI

Does the protocol of this medical experiment allow for participants aged 55 and above?

"To be eligible for this research, applicants must fall between ages 21 and 44. Conversely, there are 199 studies recruiting patients under 18 years of age and 1101 investigating treatments for those over 65."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

10-year Follow-up of Intensive Glucose Control in Type 2 Diabetes

Holman, Rury R., Sanjoy K. Paul, M. Angelyn Bethel, David R. Matthews, and H. Andrew W. Neil. 2008. “10-year Follow-up of Intensive Glucose Control in Type 2 Diabetes”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0806470.

Statistics in MedicineJournal

Multiple Imputation Using Chained Equations: Issues and Guidance for Practice

White, Ian R., Patrick Royston, and Angela M. Wood. 2010. “Multiple Imputation Using Chained Equations: Issues and Guidance for Practice”. Statistics in Medicine. Wiley. doi:10.1002/sim.4067.

Implementation ScienceJournal

Fostering Implementation of Health Services Research Findings into Practice: A Consolidated Framework for Advancing Implementation Science

Damschroder, Laura J, David C Aron, Rosalind E Keith, Susan R Kirsh, Jeffery A Alexander, and Julie C Lowery. 2009. “Fostering Implementation of Health Services Research Findings into Practice: A Consolidated Framework for Advancing Implementation Science”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/1748-5908-4-50.

clinicaltrials.govStudy