Clinical trial NCT05754008: Care Navigator Support for Younger Latinx Adults With Type 2 Diabetes
Official title: A Randomized Trial of Care Navigator to Support Younger Latinx Adults Newly Diagnosed With Type 2 Diabetes (AURORA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Care Navigator, Latinx
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 204
Sex: ALL
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Differences between study arms in HbA1c change 6-months following enrollment
timeFrame: 6-months following enrollment
Secondary outcomes:
measure: Healthcare contact
timeFrame: 6-months following enrollment
measure: Completion of recommended HbA1c monitoring
timeFrame: 6-months following enrollment
measure: T2D-related medication initiation
timeFrame: 6-months following enrollment
measure: T2D-related medication adherence
timeFrame: 6-months following enrollment
measure: Use of remote glucose monitoring to measure glucose levels
timeFrame: 6-months following enrollment
measure: Participant-reported measures: Confidence in Accessing Care
timeFrame: 3-months following enrollment
measure: Participant-reported measures: Diet and Exercise
timeFrame: 3-months following enrollment
measure: Participant-reported measures: Self-efficacy for diabetes
timeFrame: 3-months following enrollment
measure: Participant-reported measures: Motivation and locus of control
timeFrame: 3-months following enrollment
measure: Participant-reported measures: Diabetes distress
timeFrame: 3-months following enrollment
measure: Participant-reported measures: Diabetes stigma
timeFrame: 3-months following enrollment
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Anjali Gopalan, MD, MS
role: PRINCIPAL_INVESTIGATOR
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