UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050378 |
|---|---|
| Receipt number | R000057364 |
| Scientific Title | Multicentre, randomised, controlled trial of the EU-Japan Joint Virtual Coaching System (e-VITA) to improve the quality of life of older people - a proof-of-concept study. |
| Date of disclosure of the study information | 2023/02/18 |
| Last modified on | 2023/02/18 00:17:57 |
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Basic information
Public title
Multicentre, randomised, controlled trial of the EU-Japan Joint Virtual Coaching System (e-VITA) to improve the quality of life of older people - a proof-of-concept study.
Acronym
Multicentre, randomised, controlled trial of the EU-Japan Joint Virtual Coaching System (e-VITA) to improve the quality of life of older people - a proof-of-concept study.
Scientific Title
Multicentre, randomised, controlled trial of the EU-Japan Joint Virtual Coaching System (e-VITA) to improve the quality of life of older people - a proof-of-concept study.
Scientific Title:Acronym
Multicentre, randomised, controlled trial of the EU-Japan Joint Virtual Coaching System (e-VITA) to improve the quality of life of older people - a proof-of-concept study.
Region
| Japan | Europe |
Condition
Condition
Healthy women and men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The e-VITA project is a collaboration between two separate consortia of academic and industrial actors from the European Union (France, Italy, Belgium and Germany) and Japan, with the aim of developing a virtual coach for older people. These virtual coaches are installed in the homes of older people and interact with them, suggesting a range of activities and advice for an active and healthy ageing.
The aim of the study is to demonstrate that the use of the virtual coach improves the user's quality of life (QOL) as assessed by the EQ-5D-5L. It is also to measure user adherence to the virtual coach system based on the frequency of use of the virtual coach and the drop-out rate.
Basic objectives2
Others
Basic objectives -Others
Usability, user experience, acceptability, fulfilment of use
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL measured by EQ-5D-5L
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A virtual coach is set up in their home and used for a period of six months. They also receive digital support from a human coach and fortnightly advice on behaviour change by phone.
Interventions/Control_2
The control group will train on their own for 6 months using a self-training booklet that includes information on cognitive activity, physical activity, psychological well-being and nutritional activation.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-who are willing to participate in the study and meet the eligibility criteria
-Be 65 years of age or older and retired.
-Able to understand and consent to an explanation.
-Able to walk independently.
-MoCA>22 (no significant cognitive impairment).
-GDS <9 (not depressed).
-SPPB > 7 (including 7 and no motor impairment).
-Clinical Frailty Scale score between 2 and 4.
-Has a good understanding of the Japanese language.
-Consent to participate in the study.
Key exclusion criteria
Exclusion criteria.
Failure to meet the inclusion criteria.
Use of active implants or non-implant medical devices.
Allergy to nickel.
Concurrent participation in other trials.
Lack of written informed consent.
Myocardial infarction or stroke within 6 months.
Painful arthritis, scoliosis, amputation of any limb, painful foot lesions or neuropathy limiting balance and mobility.
Uncontrolled hypertension.
Patients with a pacemaker or implantable cardioverter-defibrillator.
Advanced Parkinson's disease or other neuromuscular disorders.
Metastatic cancer or immunosuppressive therapy.
Significant visual or hearing impairment.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku Universiy
Division name
Smart Aging Research Center
Zip code
9808575
Address
4-1Seiryocho, Aoba-ku, Sendai
TEL
0227178561
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Toshimi |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University
Division name
Smart Aging Research Center
Zip code
9808575
Address
4-1Seiryocho, Aoba-ku, Sendai
TEL
0227178561
Homepage URL
toshimi.ogawa.e6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1SeiryochoAoba-kuSendai
Tel
+81227178824
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 18 | Day |
Last modified on
| 2023 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057364
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