Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 主要终点
- Change in FASD Birthrate Levels
研究概览
简要总结
The Institute of Health Economics is conducting a study to determine how a breathalyzer linked to a cloud based alcohol monitoring system changes alcohol consumption during pregnancy in women with alcohol dependency issues.
IHE posits that the ability to self-monitor blood alcohol concentration and the ability to share sobriety via email or text with loved ones and counselors may reduce alcohol consumption and thus reduce the possibility of delivering a child with FASD.
The study will provide useful evidence for tailoring future optimal maternal and child healthcare for women, with the potential of decreasing healthcare utilization by prevention of FASD. Breathalyzer device usage plus secure document sobriety should improve patient monitoring convenience and demonstrate reductions in alcohol use outside of traditional office visits and patient self-reports.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant, Alcoholic, actively in treatment for alcoholism addiction
排除标准
- •Not pregnant, not in treatment/therapy for addiction
研究组 & 干预措施
Experimental
Intervention is pregnant women enrolled and using specialized breathalyzer device w face recognition technology linked to a cellphone
干预措施: specialized breathalyzer w face recognition technology (Device)
Control Group
No intervention. No breathalyzer given. Access granted by participant to IHE to collect data from Alberta Health Services (medical records)
结局指标
主要结局
Change in FASD Birthrate Levels
时间窗: 3 years
Binary- yes or no dx FASD within 3 years of birth
次要结局
未报告次要终点