Optimizing Diabetes Technology Use for Latinx Youth Through DREAM (Device Use Reimagined Through Education And Mentorship) Virtual Peer Groups [Study-wide] - DREAM Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Caregiver Survey
研究概览
简要总结
Diabetes technology, such as insulin pumps and continuous glucose monitoring devices, can help improve glucose control for people with type 1 diabetes (T1D), which keeps them at lower risk for diabetes complications, but many Latinx adolescents, who make up the largest marginalized ethnic group of youth with T1D in California, use these devices less often and have less optimal glucose control compared to White youth. In phase 1 of this project, we worked directly with Latinx youth, their families, and diabetes care team members in California to develop DREAM, Device use Reimagined through Education And Mentorship, a virtual peer group (VPG) intervention that will encourage and support the use of diabetes devices in Latinx adolescents with T1D. The goals for phase 2 (intervention) of this project are to evaluate the feasibility and acceptability of the stakeholder-informed VPG intervention, and evaluate clinical and person-centered outcomes.
详细描述
This multi-site project has two phases: phase 1 involved stakeholders focus groups to assess barriers and facilitators to diabetes technology and the creation of advisory councils. Feedback was obtained and used to develop phase 2, the single arm trial. A virtual peer group curriculum is being refined and will be implemented. The aims of this project are: (1) Partner with stakeholders to design a virtual peer group (VPG) intervention to promote the initiation and continued use of diabetes technology among Latinx adolescents with T1D. (2) Evaluate the feasibility and acceptability of DREAM VPGs in a pragmatic, single arm trial. (3) Assess the effects of DREAM VPGs on clinical and person-centered outcomes.
Our DREAM intervention will:
- Build trust/rapport and "relational connections" between participants
- Empower participants to be advocates in their/their adolescents' diabetes care
- Provide tools/knowledge to navigate healthcare and diabetes technology systems
- Increase knowledge, confidence, and interest in using diabetes technology
- Create a culturally sensitive/inclusive VPG toolkit that will be scalable, feasible, and sustainable in broader clinical contexts if found to be beneficial
The DREAM project's findings will inform future efforts to improve diabetes technology use and T1D health outcomes among Latinx adolescents. If found to be effective, the VPG curriculum can be adapted for other clinic settings in order to improve education and peer support for Latinx patients and families. Future studies may extend or adapt DREAM to other cohorts, including other age groups, geographic settings, or marginalized and historically excluded populations with T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents 13-17 years old and their caregivers
- •Adolescent must have T1D of any duration, and be receiving diabetes care at UCSF, CHLA or UC Davis
- •Self-identify as Latina/o/x or other variations such as Hispanic
- •Preferred language of English or Spanish
排除标准
- •Participants who have a medical, developmental, or psychiatric condition that would make peer group participation difficult
- •Adolescents who are planning to transfer care to a different medical center within the next year, which would prevent assessment of longitudinal outcomes
研究组 & 干预措施
Intervention
Virtual peer groups (VPGs)
Six different VPGs topics will be offered. Each VPG topic will be presented separately to youth and caregivers, in Spanish and English. Frequency of scheduling for each VPG will vary on a month-to-month basis depending on the distribution of current enrollees who have not yet discussed that topic and the availability of the relevant facilitators.
In-Person Events
Optional in-person events may be offered quarterly during the 6-12 month study participation period.
干预措施: DREAM intervention (Behavioral)
Comparator Group
An equal number of eligible non-enrolled patients at each site will be selected and matched to the enrolled cohort based on age, language, HbA1c, insurance type, and diabetes technology use at a population level.
结局指标
主要结局
Caregiver Survey
时间窗: Baseline
Captures personal and family background (e.g. gender, income)
Caregiver Phase 2 Intervention Survey - "Feedback Survey"
时间窗: End of Study to (6-15 months)
Assess various intervention components (e.g., frequency of virtual peer groups, in person events).
Caregiver In Person Event Evaluation
时间窗: Throughout the study, up to 15 months
Captures in the moment in person event feedback (e.g., improve experience and components).
Caregiver Online Group Evaluation
时间窗: Throughout the study, up to 15 months
Captures moment group feedback (e.g., improve experience and content).
Adolescent Survey
时间窗: Baseline
Captures diabetes technology, personal and family background (e.g., diabetes technology history, gender).
Adolescent Phase 2 Intervention Survey - "Feedback Survey"
时间窗: End of Study (6-15 months)
Assess various intervention components (e.g, frequency of virtual peer groups, in person events).
Adolescent In Person Event Evaluation
时间窗: Throughout the study, up to 15 months
Captures in the moment in person event feedback (e.g., improve experience and components).
Adolescent Online Group Evaluation
时间窗: Throughout the study, up to 15 months
Captures moment group feedback (e.g., improve experience and content).
Attendance at VPG and in-person events
时间窗: Throughout the study, up to 15 months
Attendance will be recorded for each in person and online events
Retention of enrolled patients
时间窗: End of Study (6-15 months)
Engagement of participants throughout study trajectory
次要结局
- Patient Health Utilization(Baseline, 3-months, 6-months, 9-months, End of Study 12 to 15-months)
- Caregiver Diabetes Distress Scale (DDS)(Baseline and End of Study (6-15 months))
- Caregiver Diabetes Family Conflict Scale (DFCS)(Baseline and End of Study (6-15 months))
- Caregiver Health Care Relationship (QHR)(Baseline and End of Study (6-15 months))
- Patient Health Utilization(Baseline, 3-months, 6-months, 9-months, End of Study 12 to 15-months)
- Adolescent Diabetes Distress Scale (DDS)(Baseline and End of Study (6-15 months))
- Adolescent Benefits and Burdens of CGM (BenCGM & BurCGM)(Baseline and End of Study (6-15 months))
- Adolescent Diabetes Family Conflict Scale, (DFCS)(Baseline and End of Study (6-15 months))
- Adolescent Diabetes Strengths and Resilience Measure (DSTAR)(Baseline and End of Study (6-15 months))
- Adolescent BenPump/Pod & BurPump/Pod(Baseline and End of Study (6-15 months))