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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AURORA Care Strategy
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Care Navigator, Latinx

Eligibility Criteria

21 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kaiser Permanente Northern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AURORA Care Strategy

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Differences between study arms in HbA1c change 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.

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2023
Last Updated
April 25, 2023
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT05754008
Brief Title
Care Navigator Support for Younger Latinx Adults With Type 2 Diabetes
Acronym
AURORA
Official Title
A Randomized Trial of Care Navigator to Support Younger Latinx Adults Newly Diagnosed With Type 2 Diabetes (AURORA)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Care Navigator, Latinx

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study team will conduct a patient-level randomized, parallel-group pragmatic trial of usual care vs. the AURORA care strategy among Latinx members (ages 18-44), recently diagnosed with T2D with a diagnosis HbA1c ≥8% (n=102/study arm). Outcomes assessed at 6 months post-enrollment will include HbA1c changes, medication initiation and adherence, and changes in patient-reported measures (e.g., self-efficacy).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AURORA Care Strategy
Arm Type
Experimental
Arm Description
Participants will receive the AURORA Care Strategy in addition to their usual diabetes care.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No intervention will be employed. This arm will continue to receive their usual diabetes care.
Intervention Type
Behavioral
Intervention Name(s)
AURORA Care Strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences between study arms in HbA1c change 6-months following enrollment
Description
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.
Time Frame
6-months following enrollment
Secondary Outcome Measure Information:
Title
Healthcare contact
Description
Differences in healthcare contact with members of the T2D diabetes care team, including care manager, PCPs, educators.
Time Frame
6-months following enrollment
Title
Completion of recommended HbA1c monitoring
Description
Completing HbA1c labs
Time Frame
6-months following enrollment
Title
T2D-related medication initiation
Description
Initiation of T2D-related medication
Time Frame
6-months following enrollment
Title
T2D-related medication adherence
Description
Adherence to T2D-related medication
Time Frame
6-months following enrollment
Title
Use of remote glucose monitoring to measure glucose levels
Description
Use of a remote glucose monitoring to measure glucose levels
Time Frame
6-months following enrollment
Title
Participant-reported measures: Confidence in Accessing Care
Description
Assessed at 3-month survey
Time Frame
3-months following enrollment
Title
Participant-reported measures: Diet and Exercise
Description
Assessed at 3-month survey
Time Frame
3-months following enrollment
Title
Participant-reported measures: Self-efficacy for diabetes
Description
Assessed at 3-month survey
Time Frame
3-months following enrollment
Title
Participant-reported measures: Motivation and locus of control
Description
Assessed at 3-month survey
Time Frame
3-months following enrollment
Title
Participant-reported measures: Diabetes distress
Description
Assessed at 3-month survey
Time Frame
3-months following enrollment
Title
Participant-reported measures: Diabetes stigma
Description
Assessed at 3-month survey
Time Frame
3-months following enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Valdati
Phone
510-410-6659
Email
amy.valdati@kp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjali Gopalan, MD, MS
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Northern California
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Valdati

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Care Navigator Support for Younger Latinx Adults With Type 2 Diabetes

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