A Randomized Trial of Care Navigator to Support Younger Latinx Adults Newly Diagnosed With Type 2 Diabetes (AURORA)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Kaiser Permanente
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- Differences between study arms in HbA1c change 6-months following enrollment
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Participant-reported measures: Motivation and locus of control(3-months following enrollment)
- Participant-reported measures: Confidence in Accessing Care(3-months following enrollment)
- Healthcare contact(6-months following enrollment)
- T2D-related medication initiation(6-months following enrollment)
- Participant-reported measures: Diet and Exercise(3-months following enrollment)
- Participant-reported measures: Diabetes stigma(3-months following enrollment)
- T2D-related medication adherence(6-months following enrollment)
- Participant-reported measures: Self-efficacy for diabetes(3-months following enrollment)
- Completion of recommended HbA1c monitoring(6-months following enrollment)
- Use of remote glucose monitoring to measure glucose levels(6-months following enrollment)
- Participant-reported measures: Diabetes distress(3-months following enrollment)