Stopping Benzodiazepines and Related Molecules Among Elderly Living in Residential Institutions: Feasibility and Impact on Sleep and Behavior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 主要终点
- Feasibility: Percentage of residents exposed to benzodiazepines & related molecules (B& RM) and eligible but refusing to participate in the trial included proportion of patients whose attending physician refuses to stop B & RM
研究概览
简要总结
Intervention randomized controlled open study with 2 parallel arms . The objective of this study is to evaluate the feasibility of stopping the benzodiazepines treatment in elderly living in nursing homes.
It will check that the judgment of these molecules has no pejorative effect on sleep or behavior of residents and does not induce withdrawal syndrome. Two patient groups will be constituted. One will begin a gradual withdrawal of benzodiazepines in six weeks. The other group will continue his treatment and withdrawal will be proposed after 8 weeks by his general practitioner (delayed intervention).
Effects on sleep will be assessed by wrist actimetry for 10 weeks and a sleep diary . The repercussions of withdrawal on behavior will be rated by the NPI scale.
详细描述
Introduction: In France, more than 30% of people over 65 consume benzodiazepines or related drugs (B & M) on a long term basis. These drugs are responsible for side effects like cognitive impairment, falls and fractures and the installation of an addiction, while their long-term efficacy is poorly documented. Recent best practice guidelines developed by the French Health Authority (HAS) focused on stopping the benzodiazepines and related drugs in elderly. Residents of geriatric institutions are particularly at risk of falls and cognitive impairment, it is possible to stop these drugs under facilitating conditions.
OBJECTIVES: To evaluate the feasibility and safety of stopping the benzodiazepines and related drugs in institutionalized elderly. Studying one year later to maintain the cessation of benzodiazepines and related drugs
METHODS:
DESIGN: Intervention Study randomized controlled open 2 parallel arms. Participating centers: 20 geriatric institutions (nursing homes)
Randomization: Residents will be included paired by geographical criteria (living unit). Residents of each pair will be randomized using a randomization list: a group in the Immediate and the other group in the delayed intervention.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residents aged 70 or older and institutionalized for over a month
- •Receiving one or more benzodiazepines and related drugs for over 30 days;
- •Corresponding to stop aspects of benzodiazepines and related drugs as recent best practice guidelines by the French health authority (HAS)
- •Signature of informed consent by the patient attended or not his guardian, the guardian or a relative;
- •General practitioner agreeing to adhere to recommendations.
排除标准
- •psychiatric pathology,
- •end of life situation
- •Refusal to participate (or representative if he is unable to consent).
研究组 & 干预措施
Immediate intervention
Gradual withdrawal of benzodiazepines or related drugs : 25% reduction of the benzodiazepines dose or related drugs every 2 weeks during nine weeks in order to stop the treatment .
干预措施: Immediate intervention (Drug)
结局指标
主要结局
Feasibility: Percentage of residents exposed to benzodiazepines & related molecules (B& RM) and eligible but refusing to participate in the trial included proportion of patients whose attending physician refuses to stop B & RM
时间窗: screening
Percentage of residents exposed to benzodiazepines \& related molecules (B\& RM) and eligible but refusing to participate in the trial included proportion of patients whose attending physician refuses to stop B \& RM
No negative impact on sleep assessed by NPI scale
时间窗: evolution between day 0 and week 10
sleep disturbances severity assessed by the score of the item to sleep NPI-scale.
No negative impact on the behavior
时间窗: evolution between day 0 and week 10
The severity of agitation and aberrant motor behavior assessed by scores on items agitation / aggression and aberrant behavior of the same scale
次要结局
- Average time of sleep(each week up to week 10)
- Average number of nighttime awakenings(each week up to week 10)
- Severity of behavioral problems assessed by NPI scale(baseline, on the 5th weeks, on the10th weeks)
- Proportion of patients with adverse events (including withdrawal symptoms).(on the 5th weeks, on the10th weeks)
- Proportion of patients discharged from study.(between day 0 and week 10)
- Proportion of patients in the immediate intervention in which the Benzodiazepines and related drugs are stopped(on the 10th weeks and after one year.)