DREAM Project Community Health Worker Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 441
- 试验地点
- 1
- 主要终点
- Change in Baseline Hemoglobin A1c at 6-Months
研究概览
简要总结
The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in New York City (NYC).
详细描述
The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in New York City (NYC). For a two-arm, randomized controlled trial (RCT), investigators will recruit a sample of 256 participants, all of whom are 1) of Bangladeshi descent, 2) residing in NYC, 3) diagnosed with Type 2 diabetes mellitus (T2DM) and a recent Hemoglobin A1c (HbA1c) of ≥ 6.5, and 4) between the ages of 21-85. The treatment group receives a six-month CHW-led intervention consisting of five monthly group educational sessions, two one-on-one visits, and follow-up phone calls as needed from a CHW. The control group receives an introductory educational session only. Primary and secondary outcomes include clinical and behavioral measures, such as HbA1c and weight change, access to and utilization of care (i.e. appointment keeping and use of specialty care), and knowledge and practice of physical activity and healthful eating. Additionally, information regarding CHW characteristics, the processes and mechanisms for influencing healthful behavior change, and fidelity of the intervention are collected. Outcomes are measured at Baseline, 3-Months, 6-Months for both groups, and at 12-Months for the treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed clinical diagnosis of T2DM with a Hemoglobin A1c (HbA1c) of ≥ 6.5%; and
- •male or female between the ages of 21-85 years old; and
- •willingness to be randomized to either treatment or control groups.
排除标准
- •is or was on renal dialysis;
- •experiencing an acute or terminal illness or serious mental illness;
- •had a history of recent coronary event within the last 3 months of recruitment;
- •is pregnant at the time of recruitment;
- •experienced other severe medical conditions that might preclude participation;
- •has poor short-term prognosis (expected death in <2 years); or
- •is participating in another research study.
研究组 & 干预措施
Full CHW Intervention
5 monthly group educational sessions, 2 1v1 Visits with CHW, Phone Calls as Needed
干预措施: CHW Intervention (Other)
Control: Intro to Diabetes Session Only
One-time, Introduction to Diabetes educational session only
结局指标
主要结局
Change in Baseline Hemoglobin A1c at 6-Months
时间窗: Baseline, 6-Months
Change in Baseline HbA1c at 6-Months
次要结局
- Change in Baseline Self-Efficacy at 6-Months(Baseline, 6-Months)
- Change in Baseline Access to / Utilization of healthcare at 6-Months(Baseline, 6-Months)
- Change in Baseline Perceived Social Support at 6-Months(Baseline, 6-Months)
- Change in Baseline Perceived Benefits & Barriers at 6-Months(Baseline, 6-Months)
- Change in Baseline Diabetic Management Practices & Knowledge at 6-Months(Baseline, 6-Months)
- Change in Baseline Engagement in Physical Activity & Healthy eating at 6-Months(Baseline, 6-Months)
- Change in Baseline Lipid Profile at 6-Months(Baseline, 6-Months)