Evaluating the Feasibility of Type 1 Diabetes Education and Support Intervention to Improve Diabetes Distress Among Black Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Diabetes Distress
研究概览
简要总结
Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.
详细描述
This research focuses on the unique needs of Black young adults aged 18-30 years to address a critical gap in the research and clinical care. The goal is to test the feasibility and preliminary efficacy of a culturally adapted and tailored intervention to enhance diabetes management strategies among Black young adults with T1D, addressing the pervasive racial disparity in health outcomes for this population.
The specific aims for this study are to:
Aim 1: Assess feasibility of the culturally tailored intervention T1DES by measuring intervention acceptability, demand (retention, completed > 80% of sessions), practicality, and implementation fidelity through participant surveys and key informant interviews with participants and the health care delivery team.
Aim 2: Evaluate the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among N=40 Black young adults age 18-30 years with T1D and elevated HbA1c (>7.5%) by comparing changes in HbA1c, diabetes distress, and self-management from baseline to 6-months post-baseline among participants randomized to T1DES compared to the diabetes education-only control condition.
The goal of this study is to provide diabetes education and emotion regulation support tailored for Black young adults' experiences that will result in sustained glycemic control and can be incorporated into adult endocrinology practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kaiser Permanente Georgia Member
- •Aged 18 - 30 years
- •Confirmed diagnosis of Type 1 diabetes
- •Hemoglobin A1c > 7.5 at time of enrollment
- •a cell phone able to send/receive text messages
- •Self-reported race of Black or African American
- •Ability to read in English and provide informed consent
排除标准
- •Developmental delay or other cognitive impairment that would render the participant unable to provide informed consent
- •Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions
- •Diabetes complications that would preclude participation in the study
研究组 & 干预措施
Diabetes Education
Participants in this arm will receive traditional diabetes education following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months.
干预措施: Diabetes Education (Behavioral)
T1DES
Participants in this arm will receive a emotion regulation intervention called T1DES following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months.
干预措施: T1DES (Behavioral)
结局指标
主要结局
Diabetes Distress
时间窗: 6 months
Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.
Diabetes Distress
时间窗: 3 months
Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.
A1C
时间窗: 3 months
Point of Care A1C
A1C
时间窗: 6months
Point of Care A1C
次要结局
未报告次要终点