Validazione Dell'Orologio ADAMO Per l'Individuazione Precoce Delle Cadute Nel Paziente Anziano
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of self-reported fall events
研究概览
简要总结
"La Casa nel Parco" (CANP) Project is a multidisciplinary project funded by the European Union and Regione Piemonte aimed to explore innovative technology application in the care of older subjects. In this context, ADAMO is a single arm open label trial evaluating the capability of a wearable watch device to correctly detect fall events in community-dwelling older subjects aged 75 years and older, at high risk of falls. Secondary objectives of the study are to identify specific patterns on telemetric measures and health status variations able to predict future fall events, and to evaluate the tolerability and the influence on patient's quality of life of this wearable device.
The main objectives of the study are to evaluate the impact of the intervention on 1) medication adherence after discharge 2) medication appropriateness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
During the follow-up period both healthcare personnel and investigators will not be aware of data (including fall events) registered by the experimental device.
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 75 years and older
- •At least 2 fall events during the 12 months previous to enrollment
- •Signed written informed consent
排除标准
- •Severe cognitive impairment
- •Bedridden condition
- •Patients unable to walk autonomously (walking aids allowed)
结局指标
主要结局
Incidence of self-reported fall events
时间窗: 6 months
Fall event incidence evaluated through scheduled phone call interviews with the patient or the caregiver, from enrollment every 15 days through to 6 months, recording also timing and context of event, environmental factors, health status at the moment of the event, health consequences, therapeutic modifications.
Incidence of device-reported fall events
时间窗: 6 months
Fall event incidence automatically evaluated by the wearable watch device, based on biometric data continuously recorded from enrollment through to 6 months.
次要结局
- Variation in quality of life reported at three levels EQ-5D (EQ-5D-5L) Questionnaire(At enrollment and at 6 months)
- Variation in fear of falling evaluated with Short Falls Efficacy Scale International (Short FES-I)(At enrollment and at 6 months)
研究者
Dott.ssa RENATA MARINELLO
Principal Investigator
A.O.U. Città della Salute e della Scienza