跳至主要内容
临床试验/NCT05563740
NCT05563740已完成不适用

Assisted vs Unassisted Domiciliary Alcohol Detoxification: A Randomised Control Trial

Dr Sneha B Suresh1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Succesful Detoxification

研究概览

简要总结

Alcohol Use Disorders (AUD) form a major public health issue in India. In a densely populated country with limited mental health resources, it is challenging to treat those with AUD appropriately. Detoxification is the first step in dealing with clinically significant AUD. Institution based detoxification is not universally available and home based detoxification is mired with poor outcomes with people resuming drinking behaviour. This trail therefore aimed to study the effect of a psychosocial intervention to improve the outcome of domiciliary alcohol detoxification. The intervention involved Brief Interventions for alcohol and daily telephone monitoring and psychosocial support of patients undergoing home detoxification.

详细描述

Background: Alcohol use is a major contributor to the worldwide disease burden. Alcohol consumption has dropped in high-income nations over the last decade, whereas it has increased in some low- and middle-income countries in Southeast Asia, including India, where alcohol use resulted in 3.4 million deaths and 14.7 million disability-adjusted life years for the year 2019.

According to World Health Organization (WHO) estimates, total adult alcohol per capita consumption (APC, in liters of pure alcohol) in India has rapidly increased from 2.3 liters (2000) to 5.5 liters (2018), with further rises anticipated until 2025, thus making alcohol use disorders an important public health issue which needs urgent attention from all stakeholders.

A considerable proportion of persons in India with Alcohol Use Disorder (AUD) do not have access to treatment for their alcohol-related disorders, resulting in an 86 percent treatment gap. Community based care options being limited; treatment for AUD is largely dependent upon institutional care, which is both limited and strained. AUD encompasses a broad range of drinking behaviors, however for the purpose of this study the term AUD will refer to drinking behavior needing clinical attention.

Detoxification is the initial stage in therapy for AUD. It can take place in the community or in an inpatient facility; the option is based on the degree of the alcohol use. Evidence suggests that community detoxification is preferable to inpatient detoxification in terms of overall success, cost-effectiveness, feasibility, treatment gap reduction, and client acceptability.

Domiciliary alcohol detoxification is a process where the management of detoxification is advised at the level of patient's home, where an alcohol dependent patient is safely detoxified without admission to an inpatient unit. Whereas in assisted domiciliary alcohol detoxification additional monitoring is provided while the patient undergoes detoxification in the community. The implementation of Mental Health Care Act 2017 recommends treatment of the patient in the community, thus domiciliary detoxification is a step in that direction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Consenting male patients aged between 18-65 years who presented in alcohol withdrawal state and were advised Domiciliary Detoxification by treating doctor.

排除标准

  • 未提供

研究组 & 干预措施

Intervention Group

Experimental

All received care for alcohol withdrawal state as is routinely provided at the centre by their respective treating doctors and followed up as directed. All treatment and follow up decisions were made by the respective treating doctors. Study team did not have any role in it.

In addition all received a session of Brief Intervention (BI) for alcohol, at the time of recruitment and again after completing detoxification. Further, patient or designated caregiver received daily phone calls and Information was provided regarding any queries related to their withdrawal or detoxification process. Adverse outcomes such as sedation, seizure, confusion were enquired for and records were kept. Patient was encouraged to continue the treatment and report back for scheduled follow ups and in case of any adverse outcomes patient was asked to report back to the treating doctor and an appointment was facilitated. Phone calls were discontinued once detoxification (CIWA < 8) was complete.

干预措施: Psychosocial (Other)

Control Group

No Intervention

All participants received care for alcohol withdrawal state as is routinely provided at the centre by their respective treating doctors and followed up as directed. All treatment and follow up decisions were made by the respective treating doctors. Study team did not have any role in it.

结局指标

主要结局

Succesful Detoxification

时间窗: Up to four weeks

Proportion of participants successfully completing detoxification as indicated by CIWA score of less than 8

次要结局

  • Abstinence at one month(One month)

研究者

发起方
Dr Sneha B Suresh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Sneha B Suresh

Principle Investigator

Goa Medical College

研究点 (1)

Loading locations...

相似试验