Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes: A Pilot Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Stanford Diabetes Self-Efficacy Scale (8- item)
研究概览
简要总结
The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants.
详细描述
This is a two-arm randomized trial. Participants will be randomized to the culturally tailored Diabetes Self-Management Education Program or standard care condition in a 1:1 allocation. All participants will receive standard type 2 diabetes care at the enrolled clinic and remain under their providers' care for the duration of the study. The culturally tailored Diabetes Education Program involves the following: 1) an initial 45-minute face-to-face consultation; and 2) six 2-hour weekly interactive educational sessions in a format to be determined (TBD) by Aim 1 (e.g., in-person, video/telephone conference call).
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
- Single (Participant)
盲法说明
Both conditions will receive standard care. We will use sequentially numbered opaque sealed envelopes to conceal the allocation determination
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-described Haitian immigrant aged 21 and older
- •Known diagnosis of type 2 diabetes for at least one year
- •Have lived in the US for at least one year
- •Have an HbA1c of 7.5%
- •Willing and able to participate in an individual interview
排除标准
- •Having a diagnosis of type 1 diabetes
- •Unable to comprehend, consent and or fully participate in the study
结局指标
主要结局
Stanford Diabetes Self-Efficacy Scale (8- item)
时间窗: (T0) baseline through (T3) 90 days post-intervention
Change in general self-efficacy 1-10, higher scores indicate improvement)
Wrist-worn actigraphy (ActiGraph) to be worn while awake
时间窗: (T0) baseline through (T3) 90 days post-intervention
Change in physical activity (Frequent physical activity indicates improvement)
Summary of Diabetes of Self-Care Activities Scale (11- item)
时间窗: (T0) baseline through (T3) 90 days post-intervention
Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)
Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro
时间窗: (T0) baseline through (T3) 90 days post-intervention
Time in range and glucose variability (More time in range and less glucose variability indicates improvement)
次要结局
- Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6((T0) baseline through (T3) 90 days post-intervention)