Remote-controlled Dispensing of Medication and Electronic Monitoring of Adherence in Ambulatory Patients With Opioid Dependency Syndrome and Polypharmacy - a Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Taking Adherence (Number of days with correctly dispensed pouches (%)
研究概览
简要总结
Electronic dispensers for polypharmacy are used in home care to assist patients with their medication management and to improve adherence. Opioid dependent patients with substitution therapy often exhibit multiple risk factors for non-adherence. The increase of both the age and associated comorbidities in this population demand for innovative solutions to optimize medication management. The investigators developed a novel medication supply model with an automated electronic medication dispenser to simultaneously assist opioid dependent patients with their medication and objectively monitor their adherence. This study aims to demonstrate the feasibility of the new supply model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •written informed consent given
- •reading and writing skills in German
- •Stable housing situation in the canton of Basel-City and adjacent communities
- •Accessibility by phone
- •Minimum duration in opioid substitution treatment for 2 months
- •Polypharmacy (> 3 solid oral medications)
- •Routine monitoring of clinical parameters less than 1 week before inclusion or agreed within 1 week from inclusion
- •Insured with Swiss health insurance
排除标准
- •opioid substitution treatment with Diacetylmorphine
- •> 2 drugs, which can not be packaged in pouches (eg liquids)
研究组 & 干预措施
electronic medication dispenser
An Automatic Tablet Dispensing and Packaging System is used to repack all solid oral prescription medications for each participant into unit-of-dose pouches. Every participant receives a roll with pouches for 14-28 days loaded into a dispenser installed at their homes. The electronic medication dispenser is a remote controlled, electronic medication management aid reminding the patients with acoustic alerts to take their medication.
干预措施: electronic medication dispenser (medido) (Device)
结局指标
主要结局
Taking Adherence (Number of days with correctly dispensed pouches (%)
时间窗: continuous, up to 24 weeks
Number of days with correctly dispensed pouches (%)
次要结局
- Timing adherence (number of correctly dispensed pouches within predefined time-frame (%)(continuous, up to 24 weeks)
- Patients' specific routine parameters according to condition(s) of participant (composite outcome)(up to 24 weeks)
- Psychological distress(inclusion, week 12, 24, 36)
- Quality of Life(inclusion, weeks 3, 6, 9, 12, 15, 18, 21, 24, 36)
- Satisfaction(week 12, 24, 36)
- Instrumental Activities of Daily Living(inclusion, week 12, 24, 36)
- Cognitive Impairment(inclusion, week 12, 24, 36)