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Care Navigator Support for Type 2 Diabetes (AURORA Trial)

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
KPNC member, age >20 and age <45 with new clinical diagnosis of T2D within the prior 1-8 months and HbA1c≥8%. If the study team are having trouble recruiting an adequate sample, the study team may lower the HbA1c threshold to ≥7.5%
Proficient (written and spoken) in English or Spanish
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
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.

AURORA Trial Timeline

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.

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
538 Previous Clinical Trials
24,113,624 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
~71 spots leftby Dec 2024