A Non-randomised Pilot Study of the Smart and Healthy Ageing Through People Engaging in Supportive Systems (SHAPES) Digital App and Platform for Supporting Medicines Optimisation in Older Individuals With Multiple Long-term Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Participants' engagement with the SHAPES app during the pilot
研究概览
简要总结
The Smart & Healthy Ageing through People Engaging in Supportive Systems (SHAPES) Innovation Action is a Horizon 2020, EU-wide project looking at how technology can enable the older population to live healthier lives at home. It involves the development, piloting and deployment of a large scale, EU-standardised open platform. This platform will integrate with a wide-range of technological, organisational, clinical, educational and societal solutions seeking to facilitate long-term healthy and active aging.
Within this project are 7 pilot themes investigating various potential uses of the platform, in Northern Ireland we are leading on medicines control and optimisation.
This pilot is focused on identifying, managing and improving deficiencies in adherence to medicines and treatments of older individuals living with permanent or temporary reduced functions or capabilities due to chronic, age-related illnesses and living at home. Digital Solutions (including blood pressure monitors, pulse oximeters, weight scales and glucometers) will be used to enable self-monitoring of the individual's physiological parameters. Data will also be used to develop an algorithm to help predict decompensations in participants with heart failure and dynamic personal ranges will also be developed. In the future this may enable early opportunities to adjust medicines and treatments so as to deliver safer and more effective use of medicines in-home, however, in this pilot there will be no changes to treatment.
The target population is composed of older individuals (+65 years) living at home with heart failure and/or diabetes. We aim to recruit 30 people (for 3 months) to our pilot in Northern Ireland. We are working closely with colleagues in Spain, Czech Republic, Cyprus and Germany to run similar pilots within their healthcare systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Northern Health and Social Care Trust service user
- •≥60 years
- •Diagnosed with heart failure and/or diabetes mellitus (treatment includes regular self-monitoring of blood glucose)
- •Lives at home or in supported living accommodation (category 1 or 2).
- •Category 1 - self-contained accommodation for the more active elderly, which may include an element of scheme supervisor support and/or additional communal facilities
- •Category 2 - scheme supervisor supported self-contained accommodation for the less active elderly, which includes the full range of communal facilities
- •Has stable self-reported Wi-Fi connection at home
- •Has access to an appropriate android smartphone or tablet
- •Android device running version 8 or above; supports Wi-Fi; supports BLE; front facing camera for facial recognition
- •Self-reported stable disease state, the participant feels well enough to take part in the pilot
- •Self-reported confident user of smartphone/tablet
排除标准
- •Participant report of cognitive impairment
- •Wears an electronic medical device or implant (e.g. pacemaker, electrocardiogram)
研究组 & 干预措施
intervention
The intervention being piloted in this study is a novel system of supporting older individuals with multiple long-term conditions to self-manage their chronic conditions through the daily use of a digital health product that can also facilitate the remote monitoring of a person's health status.
干预措施: SHAPES app (Device)
结局指标
主要结局
Participants' engagement with the SHAPES app during the pilot
时间窗: 3 months (end of pilot)
The number of times the app is opened per day
次要结局
- Change in hospitalisation rate per person (hospitalisations/month) and A&E attendance rate (attendance/month)(Three months prior to baseline compared with 3 months during the pilot)
- Correlation between participants' self-reported medication adherence and beliefs about medicines(3 months (end of pilot))
- Exploration of healthcare practitioners' views on integration and alignment of the SHAPES platform and Digital Solutions with current care pathways(3 months (end of pilot))
- Participants' beliefs about medicines(Baseline and 3 months (end of pilot))
- Exploration of participants' views about their trust and acceptance of the SHAPES app(3 months (end of pilot))
- Exploration of user engagement behaviors(3 months (end of pilot))
- Participants' user experience with the SHAPES app(3 months (end of pilot))
- Usability of the SHAPES app(3 months (end of pilot))
- Number and rate of successful registrations of each clinical parameter per participant, per day(3 months (end of pilot))
- Number and rate of heart failure decompensation prediction (HFPred) risk scores successfully generated per person(3 months (end of pilot))
- Number and rate (score/week) of heart failure decompensation prediction (HFPred) risk scores successfully generated per person during the pilot(3 months (end of pilot))
- Correlation between HFPred scores and unscheduled care during the pilot(3 months (end of pilot))
- Number and rate of control limits (upper and lower) successfully generated by the 'Vitals Control' analytic tool per person(3 months (end of pilot))
- Participants' self-reported medication adherence(Baseline and 3 months (end of pilot))
- Health-related quality of life as measured using the EuroQol 5 dimension 5 level (EQ-5D-5L) descriptive system and visual analogue scale(Baseline and 3 months (end of pilot))
- Exploration of healthcare practitioners' views about their trust and acceptance of the SHAPES platform and Digital Solutions(3 months (end of pilot))
研究者
Prof Michael Scott
Prof Michael Scott
Northern Health and Social Care Trust