Åldrande: en Innovativ Och teknologistödd hemmiljö för äldre Patienter Med Alzheimers Sjukdom, TECH@HOME.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from baseline in time spent in informal care at month 12
研究概览
简要总结
This randomized controlled trial aims to recruit a total of 320 dyads composed by persons with dementia living in community settings and their primary informal caregivers. In the intervention group, persons with dementia will have a home monitoring kit installed in the household while participants in the control group will receive their usual care. The kit includes home leaving sensors, smoke and water leak sensors, bed sensors as well as automatic lights that monitor the individual's behavior. Alerts (text message and/or phone call) will be sent to the caregiver if anything unusual occurs. All study participants will receive three home visits by project administrators that have received project specific training in order to harmonize data collection. These will take place at enrollment and 3 and 12 months following installation of the home kits. At every home visit, a standardized questionnaire will be administered to all study participants to assess their health, quality of life and resource utilization. The primary outcome of this trial is the amount of informal care support provided by primary informal caregivers to the Person with Dementia.
详细描述
While the enormous technological progress made in recent years has put technologies, such as mobile devices and smart phones, in the reach of many, innovators in dementia care are just starting to explore the full potential of these developments to transform them into valuable products and services for users. There is indeed a lack of studies that evaluate the effectiveness and cost-effectiveness of these new technologically-enriched interventions targeted at people with dementia. Previous large scale evaluations of the impact of telemedicine and telecare, such as the Whole Demonstrator System in the United Kingdom, did not include people with dementia despite Alzheimer's disease being one of the most burdensome diseases in Europe.
This randomized controlled trial aims to evaluate the effects of new technologies on caregiver burden by reducing the time spent in supervision. The trial builds on previous promising results from the UP-TECH project in Italy (https://clinicaltrials.gov/ct2/show/NCT01700556) . The technologies used in TECH@HOME will include similar, but improved, home monitoring kits potentially leading to a greater impact on caregivers' caring conditions. In addition, while the UP-TECH study did not allow the researchers to estimate the impact of the technology as a "stand-alone" intervention (the monitoring kits were only given in combination with case-management support), TECH@HOME will overcome this limitation thanks to the possibility to compare a group of technology users vs. non-users. Results from this intervention in dementia care in Sweden hold the potential to inform regional and national policy makers in Sweden and beyond.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Technology intervention
Patients randomized in the intervention group will receive a technical home monitoring kit for 12 months. The kits will be composed of a control unit and a set of sensors that immediately notify caregivers, through their phones, of any potential risks for the person with dementia. The kit will have home leaving sensors, bed occupancy sensors, smoke and water leak sensors, automatic lights, and other interactive functions. These devices will be connected to a single-board microcontroller that will transmit alarm messages to the caregivers in case of need.
干预措施: Home monitoring kit (Device)
Usual care
Patients receiving usual care, as provided to people with dementia in Southern Sweden can vary. In the target area, people with dementia usually receive comparable pharmaceutical treatment depending on the dementia type, as prescribed by a general practitioner or a specialist at a memory clinic. The social worker from the Municipality ("Biståndshandläggaren") where the person resides, together with the district nurse, have a meaningful role in tailoring the care plan by mediating access to other care services such as respite care homes, home help and (dementia) nurse home visits. Use of such services depends on the specific needs of the person with dementia, which can also be unrelated to dementia, but rather dependent upon concomitant health and social issues.
结局指标
主要结局
Change from baseline in time spent in informal care at month 12
时间窗: 12 months
The amount of informal care provided by caregivers to the persons with dementia, considered as a proxy of the caregiver burden, will be measured in hours/week and assessed using a specific section of the Resource Utilization in Dementia (RUD) instrument.
Change from baseline in time spent in informal care at month 3
时间窗: 3 months
The amount of informal care provided by caregivers to the persons with dementia, considered as a proxy of the caregiver burden, will be measured in hours/week and assessed using a specific section of the Resource Utilization in Dementia (RUD) instrument.
次要结局
- Change from baseline in Fear of falling at month 12(12 months)
- Domestic accidents at month 3(3 months)
- Change from baseline in Fear of falling at month 3(3 months)
- Change from baseline in Quality of life of the caregiver at month 12(12 months)
- Change from baseline in Quality of Life of the person with dementia at month 12(12 months)
- Change from baseline in Quality of life of the caregiver at month 3(3 months)
- Change from baseline in Caregiver burden using the Zarit Burden Inventory (ZBI) at month 12(12 months)
- Change from baseline in Quality of Life of the person with dementia at month 3(3 months)
- Change from baseline in Caregiver anxiety at month 3(3 months)
- Change from baseline in Caregiver anxiety at month 12(12 months)
- Change from baseline in Caregiver burden using the Zarit Burden Inventory (ZBI) at month 3(3 months)
- Domestic accidents at month 12(12 months)