T1CARE: A Randomized Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of participants with resolution of health-related social needs
研究概览
简要总结
Randomized controlled trial with a wait list control arm. Participants will be randomized 1:1 to T1CARE or wait list usual care arm. Participants will be recruited from the Yale Adult and Pediatric Diabetes Centers. Patients assigned to T1CARE will receive support from a Community Health Navigator at Project Access-New Haven.
详细描述
Primary Objective To determine whether the T1CARE intervention improves resolution of health-related social needs compared to usual care.
Secondary Objectives
- To assess the feasibility and acceptability of the T1CARE intervention.
- To evaluate the impact of T1CARE on patient-reported outcomes, including diabetes distress, illness intrusiveness, and quality of life.
- To examine preliminary effects on clinical outcomes, particularly changes in HbA1c.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes
- •fluent in Spanish or English who reside in the greater New Haven area
排除标准
- •cognitive impairment and otherwise unable to give written informed consent about participating in this study
研究组 & 干预措施
T1CARE
Patients who are randomized to the intervention arm will be contacted by the Community Health Navigator (CHN) from Project Access-New Haven (PA-NH) (PA-NH). The CHN will conduct an in-depth in-person intake interview to understand the patient's social and clinical need. Additional assessment will include access to insulin, diabetes technologies, and other supplies. The intake will be the basis for a personalized intervention that will respond to patient's unique needs. The initial interview will be audio-recorded to allow for qualitative data analysis. Outcomes will be measured at 6 months. Participants in the T1CARE group will have an option to join a social media platform in addition to receiving individualized support from the CHN.
干预措施: T1CARE (Behavioral)
Standard Care
Participants in the control group will be receive standard screening for SDOH and standard diabetes care at their respective clinics.
结局指标
主要结局
Number of participants with resolution of health-related social needs
时间窗: 6 months
Resolution of health-related social needs, assessed via adapted Accountable Health Communities (AHC) Model screening questions. Yes/No for resolution.
次要结局
- Change in HbA1c(6 months)
- Mean score Diabetes Distress Scale (T1-DDS)(6 months)
- Mean score Illness intrusiveness rating scale (IIRS)(6 months)
- Mean score DAWN Impact of Diabetes Profile (DIDP) scale(6 months)
- Mean score Patient satisfaction survey(6 Months)