Prevention Harmful EffectsWTCValIIINCT02899975
Interventional Validation Study (WeTakeCare-Project)
A study testing Validation in people with Prevention Harmful Effects, run by Zurich University of Applied Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention Harmful Effects
- What is being tested?
- Validation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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
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
Read more
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.
Read the detailed description
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.
Study phases
- "pre testing" of participants eligibility
- medical check
- first assessment (first part of baseline measurements)
- technical installation of the system Installation of the system at the end-users homes will be realized by staff members (See team member list) from the ZHAW.
- introduction of participants in the practical use of the system (second part of baseline measurements) To guarantee reality of the pilot it will be conducted without altering the environment except if there's environmental elements/factors posing risks to the end-users when performing the exercises/ using the program. The presence of potential risk factors will be controlled by occupational therapists, accompanying the installation of the system. If there's is any risk factor identified (i.e. reduced available space in front of the television screen), OT's (Occupational therapists) will ensure the removal. If a removal is not possible, alternate possibilities will be verified and in case of non-availability this will lead to study exclusion. After installation of the program participants will receive an initial training on functioning by occupational therapists Weekly follow-up controls will also be conducted by OT's (Occupational therapists) (short questionnaire and assessment of improvement of ADL capabilities). These OT's (Occupational therapists) will have received training in the WTC (WeTakeCare-system) use before.
- Validation phase with a permanent digital log and weekly measurement of…..
- final assessment (outcome measurements) Methods of minimising bias A description of the measures taken to minimize/avoid bias, including: Randomization, Blinding.
Within the pretesting phase possible participants are screened to validate the cognitive status as well as the physical condition to include only elderly and caregivers which have a benefit from participation.
STUDY INTERVENTION (SPIRIT #11) 8.1 Identity of Investigational Products (treatment / medical device) (ICH/E6 6.2.1, 6.4.2, 6.4.4; AGEK Checklist 2, item 3) Enrolled participants will get the technical appliances and support with the installation of the gadgets. (Kinect I (Microsoft-Kinect) and if necessary an appropriate Laptop) Occupational therapists will give a comprehensive instruction to the system, which also includes clarification of safety precautions.
The participants are free to use the system within their everyday life whenever they want.(Alone or together with their caregivers.)
- Conditions
- Prevention Harmful Effects
- Being tested
- Validation
- Keywords
- Validation, Information and Fitness Software, Elderly, WeTakeCare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValidationOther
Also called Validation of a fitness and information software
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
| Study group | Role | What they receive |
|---|---|---|
| Validation Swiss | Other | 20 german talking elderly and the non-professional caregiver will validate a Fitness and Information software Receives: Other: Validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
Question about Quality of life. We will use this assessment two times to measure a change after the intervention
Measured: Measured in Baseline and Endpoint after 3 month
Measuring a change with the assessment "Burden Scale of Family Caregivers (only caregivers)"
Question about stressing or difficult Situation concerning the caregiving.We will use this assessment two times to measure a change after the intervention
Measured: Measured in Baseline and Endpoint after 3 month
Measuring a change with the assessment "SIMPLIT" (Quality Label)
Question about usability of the prototyp. We will use this assessment two times to measure in elderly become familiar with the System while using it. SIMPLIT is a quality label that guarantees that products have been developed with a design aimed at elderly People.
Measured: Measured in Baseline and Endpoint after 3 month
Measuring a change with the assessment "Senior Fitness Test"
Measures endurance, strength, and other physiological abilities of People 60+. We will use this assessment two times to measure a change after the intervention.
Measured: Measured in Baseline and Endpoint after 3 month
Measuring a change with the assessment "Berg Balance Scale"
Measures Balance capabilities. We will use this assessment two times to measure a change after the Intervention
Measured: Measured in Baseline and Endpoint after 3 month
Measuring a change with the assessment "ICON FES" (Iconographical Falls Efficacy Scale)
Image-based assessment to evaluate fear of falling. We will use this assessment two times to measure a change after the Intervention
Measured: Measured in Baseline and Endpoint after 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention Harmful EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de València
- Responsible party
- Principal investigator, Heidrun Becker, Zurich University of Applied Sciences
- Investigators
- Rakel Poveda, Prof, Principal investigator, Universitat Politècnica de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899975
- Sponsor's protocol ID
- ZurichUAS
- Acronym
- WTCValIII
- Status last verified
- Sep 2016
- First submitted
- 14 Apr 2015
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02899975
- Acronym / sponsor ID
- WTCValIII / ZurichUAS
- Conditions
- Prevention Harmful Effects
- Keywords
- Validation, Information and Fitness Software, Elderly, WeTakeCare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Collaborators
- Universitat Politècnica de València
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study phases
- "pre testing" of participants eligibility
- medical check
- first assessment (first part of baseline measurements)
- technical installation of the system Installation of the system at the end-users homes will be realized by staff members (See team member list) from the ZHAW.
- introduction of participants in the practical use of the system (second part of baseline measurements) To guarantee reality of the pilot it will be conducted without altering the environment except if there's environmental elements/factors posing risks to the end-users when performing the exercises/ using the program. The presence of potential risk factors will be controlled by occupational therapists, accompanying the installation of the system. If there's is any risk factor identified (i.e. reduced available space in front of the television screen), OT's (Occupational therapists) will ensure the removal. If a removal is not possible, alternate possibilities will be verified and in case of non-availability this will lead to study exclusion. After installation of the program participants will receive an initial training on functioning by occupational therapists Weekly follow-up controls will also be conducted by OT's (Occupational therapists) (short questionnaire and assessment of improvement of ADL capabilities). These OT's (Occupational therapists) will have received training in the WTC (WeTakeCare-system) use before.
- Validation phase with a permanent digital log and weekly measurement of…..
- final assessment (outcome measurements) Methods of minimising bias A description of the measures taken to minimize/avoid bias, including: Randomization, Blinding.
Within the pretesting phase possible participants are screened to validate the cognitive status as well as the physical condition to include only elderly and caregivers which have a benefit from participation.
STUDY INTERVENTION (SPIRIT #11) 8.1 Identity of Investigational Products (treatment / medical device) (ICH/E6 6.2.1, 6.4.2, 6.4.4; AGEK Checklist 2, item 3) Enrolled participants will get the technical appliances and support with the installation of the gadgets. (Kinect I (Microsoft-Kinect) and if necessary an appropriate Laptop) Occupational therapists will give a comprehensive instruction to the system, which also includes clarification of safety precautions.
The participants are free to use the system within their everyday life whenever they want.(Alone or together with their caregivers.)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation Swiss | Other | Other: Validation20 german talking elderly and the non-professional caregiver will validate a Fitness and Information software |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- Elderly and caregivers
- presence of environmental risk factors inhibiting the safe accomplishment of the study
- Elderly
- Medical restrictions or instability such as
- high risk of falling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValidationAlso: Validation of a fitness and information softwareValidation 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 | Other | Validation Swiss |
Primary outcome
Measuring a change with the assessment "Performance Quality Rating Scale" (PQRS)
Time frame: 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.
6 secondary outcomes
Measuring a change with the assessment "EQ 5D" (assessment from EuroQol-Group (Researcher Network) 5D (=fifth Version)
Time frame: Measured in Baseline and Endpoint after 3 month
Measuring a change with the assessment "Burden Scale of Family Caregivers (only caregivers)"
Time frame: Measured in Baseline and Endpoint after 3 month
Measuring a change with the assessment "SIMPLIT" (Quality Label)
Time frame: Measured in Baseline and Endpoint after 3 month
Measuring a change with the assessment "Senior Fitness Test"
Time frame: Measured in Baseline and Endpoint after 3 month
Measuring a change with the assessment "Berg Balance Scale"
Time frame: Measured in Baseline and Endpoint after 3 month
Measuring a change with the assessment "ICON FES" (Iconographical Falls Efficacy Scale)
Time frame: Measured in Baseline and Endpoint after 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakel Poveda, Prof principal investigator
Universitat Politècnica de València
Questions about this trial
What is this clinical trial studying?
A study testing Validation in people with Prevention Harmful Effects, run by Zurich University of Applied Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring a change with the assessment "Performance Quality Rating Scale" (PQRS) (time frame: Measured in Baseline and Endpoint after 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.