iTAPP Study - Identification and Treatment of Alcohol Problems in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Proportion of patients exceeding the Danish national low-risk alcohol consumption limits
研究概览
简要总结
The Identification and Treatment of Alcohol Problems in Primary Care (iTAPP) Study is a pragmatic cluster randomized controlled intervention trial evaluating the effectiveness of the 15-Method as an identification and treatment tool for alcohol-related problems in Danish general practice. The 15-Method combines evidence-based approaches from specialized addiction treatment with screening and readily available treatment options in general practice to help identify and treat alcohol problems in a primary care setting. The method has shown promising results as a treatment tool in Sweden. A feasibility study of the 15-Method in Denmark suggested that the method can be implemented in Danish general practice.
The trial is led by the Unit for Clinical Alcohol Research at The University of Southern Denmark in collaboration with The Research Unit of General Practice Odense at The University of Southern Denmark.
详细描述
The study protocol with a detailed description of the iTAPP Study is in preparation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Affiliated with the participating general practices
排除标准
- 未提供
结局指标
主要结局
Proportion of patients exceeding the Danish national low-risk alcohol consumption limits
时间窗: Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024).
Using Timeline Follow Back one-week data from patient surveys. The Danish national low-risk alcohol consumption limit is maximum 10 standard units (1 unit = 12 grams of ethanol) per week and maximum 4 standard units on a single day. Patients are coded 1 (drinking above limits) or 0 (not drinking above limits).
Number of heavy drinking days per week in patients
时间窗: Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024).
The number of heavy drinking days (HDD) per week is derived from the Timeline Follow Back one-week (range 0-7 HDD/week) in patient surveys. A HDD is defined as \>4 standard units (1 unit = 12 grams of ethanol) on the same day. Is a sum of the number of days patients drink \>4 standard units.
次要结局
- Likelihood of alcohol use being addressed during a consultation in general practice(Data is collected from enrollment in trial until the end of the trail (January 2023-August 2024).)
- Frequency of use of biomarkers as a screening tool for harmful alcohol use(Data is collected 1 year prior to trial start/enrollment (January 2022-December 2023) and from enrollment in trial until the end of the trial (January 2023-August 2024).)
- Prescription rate of pharmacological treatment for alcohol problems(Data is collected 1 year prior to trial start/enrollment (January 2022-December 2023) and from enrollment in trial until the end of the trial (January 2023-August 2024).)