跳至主要内容
临床试验/CTRI/2024/03/064241
CTRI/2024/03/064241尚未招募3 期

Advancing Research to Reduce Alcohol-Related Harms - Lessons for Policy, Practice and Sustainable Development in India

London School of Hygiene & Tropical Medicine1 个研究点 分布在 1 个国家目标入组 491 人开始时间: 2024年12月2日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
491
试验地点
1
主要终点
Alcohol (gms) consumed in the past week measured using measured using the Time Line Follow Back (TLFB), a calendar tool supplemented by memory aids to obtain retrospective estimates of daily drinking over a specified time period. The TLFB is a validated instrument (Sobell & Sobell, 1992) that has been used in the study setting (Nadkarni, Weobong, et al., 2017).

研究概览

简要总结

Using systematic and evidence-based intervention development processes I will integrate interventions developed in the study setting into a single integrated intervention (APT+). The process will include consultations with various stakeholders such as expert clinicians, individuals with drinking problems, and family members; followed by evaluation of acceptability and feasibility through treatment cohorts using process evaluation and in-depth interviews with the various stakeholders. Through a hybrid effectiveness-implementation RCT with two arms I will compare enhanced usual care (EUC) with APT+.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
Male

入选标准

  • Screen positive for hazardous and harmful drinking (score >8) on the Alcohol Use Disorders Identification Test (AUDIT).

排除标准

  • Severe mental disorder Requiring emergency medical treatment.

结局指标

主要结局

Alcohol (gms) consumed in the past week measured using measured using the Time Line Follow Back (TLFB), a calendar tool supplemented by memory aids to obtain retrospective estimates of daily drinking over a specified time period. The TLFB is a validated instrument (Sobell & Sobell, 1992) that has been used in the study setting (Nadkarni, Weobong, et al., 2017).

时间窗: 3 months post randomisation

次要结局

  • Percentage days abstinent (PDA)
  • Alcohol (gms) consumed in the past week(12 months)
  • Percentage days heavy drinking (PDHD)(3 months and 12 months)
  • Abstinence
  • Remission (score <8)(3 months and 12 months)
  • Recovery (Remission at 3 and 12 months)(3 and 12 months)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Abhijit Nadkarni

Sangath

研究点 (1)

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