The Connect Trial: Connecting Hospital Patients to Alcohol Care - a Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
The main objective of this pilot study is to assess feasibility of conducting a definitive RCT with concealed allocation, blinded outcome assessment and a 1:1 parallel group design of A) an invitation to meet an AUD therapist for up to 10 treatment sessions at the hospital in up to 6 months (intervention) compared to B) guidance on how to seek alcohol care in an AUD treatment centre in the community, outside of the hospital (control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
allocation concealment
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalised or seen in an outpatient clinic at SUH Køge
- •Full-filling international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use
- •Informed written consent
- •Being able to meet the AUD therapist in connection with a hospital visit with a health condition wholly or partly attributable to alcohol
排除标准
- •Ongoing specialized treatment for AUD
- •Not speaking Danish
- •Not living in the catchment area of Zealand University hospital
- •Age < 18 years
- •Enrolled in the Zealand alcohol-related liver disease cohort study
结局指标
主要结局
Recruitment
时间窗: 6 months
\>50% of eligible individuals invited to the study give written informed consent
Retention
时间窗: 6 months
\>50% individuals recruited and randomized to the intervention, will attend to the intervention of seing the AUD therapist at least once
Completion
时间窗: 6 months
\>50% of all randomized study participants complete the follow-up interview and blood sample
次要结局
- Number of AUD treatment sessions(6 months)
- Proportion initiating medical AUD therapy(6 months)
- Proportion receiving medical AUD treatment at 6- and 12 months follow up(12 months)
- Change in blood phosphatidyl ethanol level from baseline to 6 months after inclusion(6 months)
- Number of acute hospital admissions or emergency room visits at 6 and 12 months(12 months)
- Change in motivation to cut down on alcohol (yes or no), calculated as the difference between baseline and 6 months follow-up(6 months)
- AUD treatment engagement after 6 and 12 months(12 months)
- Mortality after 6 and 12 months(12 months)
- Change in drinks (containing 12 g ethanol) per last 30 days from baseline till 6 months after inclusion(6 months)
- Proportion with abstinence or light drinking (<10 drinks/week) last 30 days(6 months)
- Number of hospital outpatient visits at 6 and 12 months(12 months)
- 3- year follow-up, conducted through health care registries and AUD treatment facilities to look for incidence of alcohol-related morbidity and mortality, visits to general practitioner and hospital contacts(3 years)
研究者
Gro Askgaard
MD PhD
Zealand University Hospital