Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDECIDE) Among Unrepresented Groups With Poor Cardiovascular and Cardiometabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Percentage of participants adhering to the intervention
研究概览
简要总结
The objective of the UDECIDE study is to demonstrate adherence to decentralized clinical trials among underrepresented groups with cardiometabolic conditions .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of pre-diabetes/diabetes and/or pre-hypertension/hypertension
- •History of Cardiometabolic risk factors including the following: hypertension, Coronary Artery Disease (CAD), heart attack, heart failure, stroke, atherosclerosis, arrhythmias, Peripheral Artery Disease (PAD), type 2 diabetes, metabolic syndrome, obesity, dyslipidemia, insulin resistance, or elevated cholesterol.
- •Identify as Black or non-White Hispanic
- •Own a smart phone
排除标准
- •Does not meet inclusion criteria
研究组 & 干预措施
Control Group
Participants in this group will be receiving the standard of care for up to 3 months.
干预措施: Control Group (Other)
Decentralized Group
Participants in this group will be receiving the decentralized intervention for up to 3 months.
干预措施: Decentralized Group (Behavioral)
Digital Literacy Navigation Group
Participants in this group will be receiving the Digital Literacy Navigation intervention for up to 3 months.
干预措施: Decentralized Group (Behavioral)
Digital Literacy Navigation Group
Participants in this group will be receiving the Digital Literacy Navigation intervention for up to 3 months.
干预措施: Digital Literacy Navigation Group (Behavioral)
Social Care Navigation Group
Participants in this group will be receiving the Social Care Navigation intervention for up to 3 months.
干预措施: Decentralized Group (Behavioral)
Social Care Navigation Group
Participants in this group will be receiving the Social Care Navigation intervention for up to 3 months.
干预措施: Digital Literacy Navigation Group (Behavioral)
Social Care Navigation Group
Participants in this group will be receiving the Social Care Navigation intervention for up to 3 months.
干预措施: Social Care Navigation Group (Behavioral)
结局指标
主要结局
Percentage of participants adhering to the intervention
时间窗: 3 months
Will be measured in percentage
Percentage of participants retained in the intervention
时间窗: 3 months
Will be measured in percentage
次要结局
未报告次要终点
研究者
Azizi Seixas
Associate Professor
University of Miami