Culturally Grounded Diabetes Intervention With Lakota Populations in South Dakota
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin (HbA1c)
研究概览
简要总结
The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to address the unique underlying risk and protective factors and social determinants of diabetes among American Indian/Alaska Native (AI/AN) populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent Evaluators are masked to the study participants' randomized group status/
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Index Participants:
- •18 years and older
- •Self-identifies as American Indian or Alaska Native
- •Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center
- •Verification from a health provider to confirm Type 2 Diabetes diagnosis by laboratory test.
- •Caregiver to a 10- to 25-year-old in their home at the time of screening.
- •Willing to complete all implementation and follow-up assessments.
- •Willing to be randomized for the intervention.
排除标准
- •Adult Index Participants:
- •Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
- •Willing to serve as 'support person' for the adult participant.
- •Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation
- •Inclusion Criteria - Youth Support Participants:
- •Between 10 years and 25 years old
- •Self-identifies as American Indian or Alaska Native.
- •Willing to serve as 'support person' for the adult participant.
- •Willing to complete all implementation and follow-up assessments.
- •Willing to be randomized for the intervention.
- •Exclusion Criteria - Youth Support Participants:
- •Cognitively or visually impaired
- •Youth in foster care (due to potential mobility of foster youth).
研究组 & 干预措施
Waitlist Standard of Care
Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.
干预措施: Waitlist Standard of Care (Behavioral)
Together Overcoming Diabetes Intervention
Together Overcoming Diabetes curriculum adapted for Lakota caregivers and the caregivers families
干预措施: TOD Great Plains (Behavioral)
结局指标
主要结局
Glycated hemoglobin (HbA1c)
时间窗: Baseline, 3 months, 6 months, and 12 months
Glycated hemoglobin as measured by a point-of-care A1c test
次要结局
未报告次要终点