Effectiveness of brief intervention on alcohol consumption among Chronic Liver Disease patients with alcohol use disorder at Institute of Liver and Biliary Sciences, New Delhi.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ILBS
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Rate of alcohol consumption among Chronic Liver Disease patients with alcohol use disorder.
研究概览
简要总结
A randomized control trial is planned to be implemented on sample of 110 subjects who met inclusion criteria to see for effectiveness of brief intervention given by world Health Organization.
Goal of the study is to evaluate effectiveness of Brief intervention on alcohol consumption among Chronic liver disease patients with alcohol use disorder.
Background of Study
Alcohol consumption, particularly heavy drinking, is an important risk factor for many health problems and represents a considerable contributor to the global burden of disease. As highlighted by the World Health Organization (WHO), public health problems caused by harmful use of alcohol represent a substantial health, social and economic burden worldwide. Harmful alcohol use seems a risk factor in more than 60 diseases and injuries resulting in approximately 2.5 million deaths per year worldwide. (Addolorato et al., 2013).
A study from Bangalore reported that one-fourth of adult men consumed alcohol. There are more than 200 million alcohol users estimated in India including 1.5 million deaths due to Alcoholic liver disease (Ray et al., 2014)
Several meta-analyses have shown that screening using short questionnaires followed by brief intervention that is comprising simple advice or psychological counseling, significantly reduces alcohol consumption in primary care populations.(Kaner et al., 2013).
Findings from a research published in Addiction science and Clinical practice 2013, these findings have been mixed as to whether brief intervention (BI) is appropriate and effective for individuals with more severe alcohol use problems. Motivation to change drinking has been supported as a mechanism of behavior change for BI. The exploratory study examined aspects of motivation as mechanisms of clinical response to BI and alcohol problem severity as a moderator of treatment effects.(Meredith et al., 2021)
The study will focus on reducing alcohol use in patients who is suffering from alcohol use diseases with the use of brief intervention.
Objectives of the Study
Primary objective:
1. To evaluate effectiveness of brief intervention© on alcohol consumption among chronic liver disease patients with alcohol use disorder in Institute of Liver and Biliary Sciences, New Delhi.
Secondary objective:
1. To find association of alcohol consumption with selected clinical variables among Chronic Liver disease patients with alcohol use disorder.
2. To find association of alcohol consumption with selected socio-demographic variables among Chronic Liver disease patients with alcohol use disorder.
| Setting of the Study: |
Outpatient and inpatient department of Institute of Liver and Biliary Sciences, New Delhi.
|Population:
CLD patients with Alcohol use disorder
|Sampling Technique:
Consecutive Sampling
Duration of intervention: Brief intervention© is short counseling session of about 10 minutes provided at Day 0, 7,30 and 60.
The planned intervention is given in 2 phases:
Phase 1. Rapport building.
Points to be discussed in sessions are:
· Scores on AUDIT
· Indication of scores
· History of alcoholism
· Client’s feelings on his drinking pattern
· Stage of behavioral change
Phase 2. Brief Intervention© session
Points to be discussed in this are:
• Harmful Effects of Alcohol
• Myths about de-addiction
• Quality of life without alcohol
• Perception of subject related to pros and cons of drinking
• High risk situations and their prevention
• Stick to plans
Screening is done with Alcohol Use Disorder Identification Test (AUDIT) before randomization, after providing intervention, the subjects are retested with AUDIT at Day 7, 30, 60 and 90
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- Male
入选标准
- •Under criteria ICD 10
- •Scores more than 8 in AUDIT (moderate to severe risk)
- •Can understand English/ Hindi
- •Will visit the selected outpatient and admitted in inpatient department at ILBS.
排除标准
- •Patients with mental impairment, not able to provide informed consent
- •Those already undergoing alcohol reduction treatment.
结局指标
主要结局
Rate of alcohol consumption among Chronic Liver Disease patients with alcohol use disorder.
时间窗: At day 7, 30, 60 and 90
次要结局
- Association of alcohol consumption with selected clinical variables among Chronic Liver disease patients with alcohol use disorder.(At day 7, 30, 60 and 90)
- Association of alcohol consumption with selected socio-demographic variables among Chronic Liver disease patients with alcohol use disorder.(At day 7, 30, 60 and 90)
