Interventional Validation Study (WeTakeCare-Project)

NCT02899975 | Completed

• 1 other identifier: ZurichUAS
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prevention Harmful Effects

Keywords

Validation; Information and Fitness Software; Elderly; WeTakeCare

Outcome Measures

Primary Outcomes (1)

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

  Measures the completeness and Quality of performing different daily tasks. We will use this assessment two times to measure a change after the Intervention.

  Measured in Baseline and Endpoint after 3 month

Secondary Outcomes (6)

• 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 "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 "Senior Fitness Test"

  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

Study Arms (1)

Validation Swiss

OTHER

20 german talking elderly and the non-professional caregiver will validate a Fitness and Information software

Other: Validation

Interventions

Validation OTHER

Validation of fitness and information software for elderly and caregivers. The participants use a Fitness Software for 2-3 months in their own homes. They should use it 3 times a week The aim of this Intervention is to find out if the regularly use of the Software maintains or improves your physical capabilities. The caregivers also use the games and get a lot of Information about supporting the elderly Person in their everyday life

Also known as: Validation of a fitness and information software

Validation Swiss

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zurich University of Applied Sciences: lead
• Universitat Politècnica de València: collaborator

MeSH Terms

Interventions

Validation Studies as Topic

Intervention Hierarchy (Ancestors)

Evaluation Studies as Topic; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Rakel Poveda, Prof

  Universitat Politècnica de València

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr. phil.

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: September 14, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share