NCT03937180已完成不适用
The Effectiveness of a Blended Care Program for the Discontinuation of Benzodiazepines Use for Sleeping Problems in Primary Care: a Clustered Randomized Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 924
- 试验地点
- 175
- 主要终点
- Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening
研究概览
简要总结
This study aims to compare two strategies performed by GPs to help patients taking benzodiazepines on a daily basis for at least six months to discontinue their use. The first strategy consists of the usual or standard support provided by the GP, which often starts with a discontinuation advice or letter, the second is blended support where face-to-face consultations with the GP are alternated with web-based self-learning by the patient.
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
- 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
- 否
入选标准
- •Patients aged 18 and older capable of giving informed consent,
- •Having his/her Global Medical File managed by one of the participating general practitioners
- •Receiving prescriptions of (z-)BZDs from participating GP for use on a daily basis
- •Reporting daily intake (≥ 80% of days) of (z-)BZDs in the last 6 months for a primary indication of sleeping problems
排除标准
- •Presence of any severe psychiatric and neurologic condition that in the judgment of the treating GP implies a contraindication for (z-)BZD withdrawal
- •Presence of terminal illness
- •Any cases where stopping of (z-)BZDs might be harmful
- •Unwillingness or inability to provide informed consent
- •Not having e-literacy (being familiar with email and internet use)
- •Patients with a substance use disorder (other than (z-)BZD) will also be excluded from the study because in these cases there is often a sub-therapeutic (z-)BZD dependence and/or comorbid psychological/psychiatric comorbid conditions requiring specialist care.
结局指标
主要结局
Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening
时间窗: 12 months
Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD
次要结局
- Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening(6 months)
- EQ-5D-3L assessed at week 6, 12, 26 and 52(12 months)
- Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52(12 months)
- The number of defined daily doses (DDD) of (z-)BZD prescribed in the preceding interval assessed at week 6, 12, 26 and 52(12 months)
研究者
Kristien Coteur
Project manager - p.p. Chief investigator prof. dr. Catharina Matheï
KU Leuven
研究点 (175)
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