Interventional Study to Validate a Investigational Fitness and Information Software for Healthy Elderly and Their Informal Caregivers Within the Scope of the EU (European Union) (AAL: Ambient Active Living) Project WeTakeCare
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 主要终点
- Measuring a change with the assessment "Performance Quality Rating Scale" (PQRS)
研究概览
简要总结
The objective of this study is to validate the prototype of the WeTakeCare- system in the real environment (=end users homes) and is embedded in Work-Package 4 (validation and evaluation) with the following main tasks:
T4.1. Definition of methodologies and protocols T4.2. First validation: concept assessment T4.3. Second validation: functional assessment T4.4. Third validation: real environment T4.5. Final check
Within the validation phase III of our project the investigators want to validate the contents of our fitness and information software WeTakeCare with the target group: elderly and their unprofessional caregivers. It runs on the Microsoft Kinect-System, which is authorised in Switzerland, and is in accordance with the prescribing information. The fitness- and information software contains information about strategies and devices which are available in case an older person is not able to perform the everyday movements in a safe and easy way.
Aim of the training and information software is to support elderly to stay independent from others help as long as possible. The mentioned software is not a medical or therapeutical treatment or a medical or therapeutical product. Performed exercises or presented information are highly regarded in the interest of safety and protection of the participants, and serves to prevent physical restrictions or damage .
There is only minimal risk or burden for the participants; the contents of the intervention itself (training of basic motor skills, instruction of strategies and the use of assistive devices to (partly) compensate restrictions in ADL performance, enablement of caregivers) are a standard in rehabilitation of elderly.
The investigators expect the start of the third validation in October 2015.
详细描述
General study design and justification of design
Type of study: Validation of the prototype of the fitness- and information Software: WeTakeCare (pilot test) in a pre- post design, no comparators
Duration:
- Preparation of the validation study containing: recruiting, pre-screening, assessing, instructing (2-4 month)
- Validation implies the use of the system during expected 3-6 consecutive months, starting soonest in October 2015- (expected) April 2016.
Population to be studied: Healthy elderly (aged 50+) with mild to moderate restrictions in the performance of ADL and their caregivers Number of participants: Involvement of a total of 20 couples in Switzerland. Incorporating 2-5 couples in the first month to allow detection and resolution of any problem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy elderly with mild to moderate restrictions in performance of ADL, support from an informal caregiver
- •aged > 50 years
- •living in the German-speaking part of Switzerland
- •with self-perceived reduced abilities in the performance of ADL and help from an informal caregiver Caregivers
- •aged > 18 years
- •expenditure of care > i.e. 1-2 times/week; > 1-2 hrs/week,…
- •Elderly and caregivers
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •Good knowledge of German language
- •Availability of internet connection
排除标准
- •Elderly and caregivers
- •presence of environmental risk factors inhibiting the safe accomplishment of the study
- •Medical restrictions or instability such as
- •History of epilepsy
- •Severe cardiovascular disorders
- •Severe neurological disorders
- •Surgery less than 3 months ago
- •Recent fractures (< 6 weeks ago and/or instable)
- •moderate to severe depression
- •non- correctible hearing and/or visual impairment
- •progressive or terminal illness
- •cognitive restrictions (MMSE score < 24)
- •high risk of falling
- •Severe restrictions in ADL performance
- •living in a care facility
- •receiving professional care
结局指标
主要结局
Measuring a change with the assessment "Performance Quality Rating Scale" (PQRS)
时间窗: Measured in Baseline and Endpoint after 3 month
Measures the completeness and Quality of performing different daily tasks. We will use this assessment two times to measure a change after the Intervention.
次要结局
- Measuring a change with the assessment "EQ 5D" (assessment from EuroQol-Group (Researcher Network) 5D (=fifth Version)(Measured in Baseline and Endpoint after 3 month)
- Measuring a change with the assessment "Senior Fitness Test"(Measured in Baseline and Endpoint after 3 month)
- Measuring a change with the assessment "Burden Scale of Family Caregivers (only caregivers)"(Measured in Baseline and Endpoint after 3 month)
- Measuring a change with the assessment "SIMPLIT" (Quality Label)(Measured in Baseline and Endpoint after 3 month)
- Measuring a change with the assessment "Berg Balance Scale"(Measured in Baseline and Endpoint after 3 month)
- Measuring a change with the assessment "ICON FES" (Iconographical Falls Efficacy Scale)(Measured in Baseline and Endpoint after 3 month)
研究者
Heidrun Becker
Prof.Dr. phil.
Zurich University of Applied Sciences