Care Navigator Support for Younger Latinx Adults With Type 2 Diabetes (AURORA)

May 2, 2024 updated by: Kaiser Permanente

A Randomized Trial of Care Navigator to Support Younger Latinx Adults Newly Diagnosed With Type 2 Diabetes (AURORA)

The study proposes to rigorously evaluate a proactive, culturally responsive care navigator intervention targeting younger-onset Latinx individuals with a new T2D diagnosis (AURORA [Active Outreach to Younger Latinx]) within Kaiser Permanente Northern California (KPNC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study has three primary objectives: 1) learn what is required to create and sustain a care navigator workforce and document our experience hiring a care navigator for the study, 2) implement and evaluate the AURORA strategy within KPNC, and 3) refine and adapt the AURORA strategy for future Kaiser Permanente (KP) wide dissemination. The AURORA strategy centers on a care navigator who will proactively conduct three telemedicine visits tailored to Latinx adults with early onset type 2 diabetes (T2D, defined as age <45 years). The AURORA strategy will conducted with the following five goals: 1) assessment of familiarity and use of T2D care within KP, 2) assessment of individual's self-management support needs, 3) motivational interviewing to support behavior change, 4) pragmatic skills training, including use of crucial technologies to support self-management, and 5) matching member's needs with existing KPNC T2D resources.

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Recruiting
        • Kaiser Permanente Northern California
        • Contact:
          • Amy Valdati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • KPNC member, age >20 and age <45 with
  • New clinical diagnosis of T2D within the prior 1-8 months
  • 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

Exclusion Criteria:

  • Pregnant women
  • Type 1 Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AURORA Care Strategy
Participants will receive the AURORA Care Strategy in addition to their usual diabetes care.
Behavioral: AURORA Care Strategy
Participants will be invited to partake in three telemedicine visits with the care navigator during the months following diagnosis. The visits center around proactive and tailored T2D self-management support.
No Intervention: Usual Care
No intervention will be employed. This arm will continue to receive their usual diabetes care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences between study arms in HbA1c change 6-months following enrollment
Time Frame: 6-months following enrollment
Change in HbA1c will be assessed using HbA1c values obtained through routine care, with the most recent HbA1c preceding study enrollment and the HbA1c value closest to 6-months following enrollment used to assess HbA1c change.
6-months following enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare contact
Time Frame: 6-months following enrollment
Differences in healthcare contact with members of the T2D diabetes care team, including care manager, PCPs, educators.
6-months following enrollment
Completion of recommended HbA1c monitoring
Time Frame: 6-months following enrollment
Completing HbA1c labs
6-months following enrollment
T2D-related medication initiation
Time Frame: 6-months following enrollment
Initiation of T2D-related medication
6-months following enrollment
T2D-related medication adherence
Time Frame: 6-months following enrollment
Adherence to T2D-related medication
6-months following enrollment
Use of remote glucose monitoring to measure glucose levels
Time Frame: 6-months following enrollment
Use of a remote glucose monitoring to measure glucose levels
6-months following enrollment
Participant-reported measures: Confidence in Accessing Care
Time Frame: 3-months following enrollment
Assessed at 3-month survey
3-months following enrollment
Participant-reported measures: Diet and Exercise
Time Frame: 3-months following enrollment
Assessed at 3-month survey
3-months following enrollment
Participant-reported measures: Self-efficacy for diabetes
Time Frame: 3-months following enrollment
Assessed at 3-month survey
3-months following enrollment
Participant-reported measures: Motivation and locus of control
Time Frame: 3-months following enrollment
Assessed at 3-month survey
3-months following enrollment
Participant-reported measures: Diabetes distress
Time Frame: 3-months following enrollment
Assessed at 3-month survey
3-months following enrollment
Participant-reported measures: Diabetes stigma
Time Frame: 3-months following enrollment
Assessed at 3-month survey
3-months following enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: Anjali Gopalan, MD, MS, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1833646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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