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临床试验/NCT05747703
NCT05747703进行中(未招募)不适用

A Telehealth Intervention to Increase Screening and Treatment for Alcohol Use Disorder

Ria Health1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2024年1月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
135
试验地点
1
主要终点
percent of subjects without heavy drinking

研究概览

简要总结

Participants with alcohol use disorder will be randomly assigned to either the Ria Treatment Platform or a waitlist control. The Ria Treatment Platform is a telehealth approach that incorporates medical assessment, medications for alcohol use disorder, individual and group coaching, educational video modules, and a Bluetooth-enabled breathalyzer. Patients are followed for three months during which data are collected, including measures of alcohol consumption and its consequences.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • alcohol use disorder

排除标准

  • inability to provide informed consent

研究组 & 干预措施

waitlist control

No Intervention

Patients in this arm will not be provided treatment during the study period.

Ria Treatment Platfrom

Experimental

The Ria Treatment Platform is a telehealth approach that includes medical assessment, prescription of clinically appropriate medications for alcohol use disorder, individual and group coaching, educational video modules, and monitoring of breath alcohol concentrations through a Bluetooth-enabled breathalyzer.

干预措施: Ria Treatment Platform (Combination Product)

结局指标

主要结局

percent of subjects without heavy drinking

时间窗: last four weeks

percent of subjects without heavy drinking per timeline follow-back

Percent of subjects without heavy drinking days

时间窗: Final 4 weeks of the 12-week trial period

Heavy drinking is defined as 5 or more standard drinks per day for men and 4 or more standard drinks per day for women, as assessed by the Timeline Followback.

次要结局

  • Proportion of abstinent days(12-week trial period)
  • Liver function (ALT, AST, GGT)(12 weeks)

研究者

发起方
Ria Health
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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