Recruiting

Observational Study

Sponsor:

Kaiser Permanente

Code:

NCT05754008

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 21 - 44

Healthy Volunteers: Accepted

Interventions

AURORA Care Strategy

Study Details

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).

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT05754008

Start date

Mar 31, 2023

Status verified date

May, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Apr 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 44

Healthy Volunteers: Accepted

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 Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: AURORA Care Strategy

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

no intervention: Usual Care

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

Interventions

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.

Primary outcome measure

  • Differences between study arms in HbA1c change 6-months following enrollment [ Time Frame: 6-months following enrollment ]

Central Contacts and Locations

Central contacts

Amy Valdati

510-410-6659amy.valdati@kp.org

Locations

Kaiser Permanente Northern California

Recruiting

Oakland, California, United States, 94612

More Information

Sponsor

Kaiser Permanente

Last update posted

May 3, 2024

Last verified

May, 2024

Keywords

  • Care Navigator, Latinx

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2024-05-03.