A Randomized Trial of Care Navigator to Support Younger Latinx Adults Newly Diagnosed With Type 2 Diabetes (AURORA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Differences between study arms in HbA1c change 6-months following enrollment
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pregnant women
- •Type 1 Diabetes
结局指标
主要结局
Differences between study arms in HbA1c change 6-months following enrollment
时间窗: 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.
次要结局
- 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)