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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
Must not have
Type 1 Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months following enrollment
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have Type 1 Diabetes.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Differences between study arms in HbA1c change 6-months following enrollment
Secondary study objectives
Completion of recommended HbA1c monitoring
Healthcare contact
Participant-reported measures: Confidence in Accessing Care
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
552 Previous Clinical Trials
27,731,418 Total Patients Enrolled
11 Trials studying Diabetes
312,323 Patients Enrolled for Diabetes
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
Diabetes Research Study Groups: AURORA Care Strategy, Usual Care
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
~34 spots leftby Apr 2025
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