CompletedNot Applicable

Interventional Validation Study (WeTakeCare-Project)

13 participantsStarted 2016-01

Plain-language summary

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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Elderly * 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 Exclusion Criteria: * Elderly and caregivers * presence of environmental risk factors inhibiting the safe accomplishment of the study Elderly * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measuring a change with the assessment "Performance Quality Rating Scale" (PQRS)

Timeframe: Measured in Baseline and Endpoint after 3 month

Trial details

NCT IDNCT02899975

SponsorZurich University of Applied Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

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