Can Connected Devices Increase the Success Rate of Benzodiazepine Withdrawals in the Elderly?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- success to stop or reduce benzodiazepine consumption
研究概览
简要总结
This is a prospective randomized open study, which aims to evaluate the benefit of a connected watch to help people aged 65 years and older to withdraw from BZD over a six-month period, compared with classical withdrawal (e.g without connected watch). The study will include 100 patients, 50 in the control group and 50 in the intervention group.
Participants will be identified during a 12-month period through either external geriatric consultations or during a brief hospitalisation.
详细描述
Despite a trivialized use of benzodiazepine (BZD) in elderly people (EP), long-term efficacy is often questioned, and treatment has to be regularly re-examined to avoid side effects. Typical intervention techniques to aid patients in reducing their dosage involve: providing information about BZD, explaining the risks associated with a chronic exposure, and tips for a successful withdrawal. In addition, the usage of a connected device may reinforce the patient's motivation by providing details on the quality of sleep and the number of steps taken (activity).
This is a prospective randomized open study, which aims to evaluate the benefit of a connected watch to help people aged 65 years and older to withdraw from BZD over a six-month period, compared with classical withdrawal (e.g without connected watch). The study will include 100 patients, 50 in the control group and 50 in the intervention group.
Participants will be identified during a 12-month period through either external geriatric consultations or during a brief hospitalisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unassisted mobility (1/1 for the locomotion item on KATZ Activities of Daily Living scale)
- •Mini-Mental State Examination (MMSE) ≥ 20
- •With a daily consumption of benzodiazepine for more than 3 months
- •Smartphone and/or tablet with internet connection
排除标准
- •Patient under legal protection
- •Patient refuses to participate
- •Patient does not speak French
结局指标
主要结局
success to stop or reduce benzodiazepine consumption
时间窗: 6 months
success to stop benzodiazepine consumption (no more intake) or reduce benzodiazepine consumption (decrease in dosage of more than 25% or non-daily intake)
次要结局
未报告次要终点