VIP (Very Important Patient) Project on Alcohol and Drug Abusers - RCT of Efficacy of the Adding the Health Promotion and Rehabilitation for Treatment of Alcohol and Drug Abusers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Change from abuser to non-abuser
研究概览
简要总结
The purpose of this study is to evaluate the effect of adding the Health Promotion activities and rehabilitation to the usual alcohol and drug interventions on the outcome for alcohol and drug abusers compared to the usual intervention alone.
详细描述
Background: Alcohol and drug abuse are followed by tremendous physical, psychological and social problems as well as early death. Heavy smoking, poor nutrition, physical inactivity and chronic diseases (co-morbidity) are often part of these problems and illnesses.
There seems to be a large potential for a better outcome by including smoking cessation, physical training, diet and nutrition as well as co-morbidity in a multi-disciplinary setting - a potential not used yet. This Very Integrated Program (VIP) is inspired from the rehabilitation offered to patients with chronic diseases and surgical patients having a likewise unhealthy lifestyle and similar co-morbidity.
Aim: to evaluate the effect of adding the VIP program to the usual alcohol and drug intervention on the outcome for alcohol and drug abusers compared to the usual intervention alone.
The VIP project consists of 3 steps:
- To map the health status and estimate the potential improvement for 400 alcohol and drug abusers
- To pilot test the VIP program
- To evaluate it compared to the daily routines for 260 alcohol and drug abusers with a poor health status in a randomised controlled trial.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •alcohol or drug dependency
排除标准
- •withdrawal of informed consent
- •missing competence to give informed consent
- •pregnant or nursing women
研究组 & 干预措施
Health Promotion activities
干预措施: Health promotion activities (Behavioral)
No Intervention
结局指标
主要结局
Change from abuser to non-abuser
时间窗: 6 weeks, 3, 6, 9, 12 and 24 months
次要结局
- Health status(6 weeks, 3, 6, 9, 12 and 24 months)
- Quality of life(6 weeks, 3,6,9,12 and 24 months)
- Harm reduction(6 weeks, 3,6,9,12 and 24 months)
- Cost-effectiveness(24 months)
研究者
Hanne Tønnesen
Professor
Lund University