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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041548
Receipt No. R000047431
Scientific Title Effects on practice of Tactile Car to quality of life (quality of life) and consciousness for dementia among the elderly in the group homes
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/25

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Basic information
Public title Effects on practice of Tactile Car to quality of life (quality of life) and consciousness for dementia among the elderly in the group homes
Acronym Effects on practice of Tactile Car to quality of life (quality of life) and consciousness for dementia among the elderly in the group homes
Scientific Title Effects on practice of Tactile Car to quality of life (quality of life) and consciousness for dementia among the elderly in the group homes
Scientific Title:Acronym Effects on practice of Tactile Car to quality of life (quality of life) and consciousness for dementia among the elderly in the group homes
Region
Japan

Condition
Condition th elderly
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Tactile Care in the group of the elderly people determines the effect that practice of the care gives to consciousness for quality of life (quality of life) and dementia from the both sides of a quantitative study (questionary survey) and the qualitative study (focus group interview) investigation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes quality of life, JST-Index of Competence: JST-IC
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Tactile Care
Interventions/Control_2
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Normal person 70 years or older
Key exclusion criteria healthy paerson
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Mizue
Middle name
Last name Suzuki
Organization Hamamatsu University School of Medicine
Division name Faculty of Nursing
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL 053-435-2826
Email mizuesuzuki@gmail.com

Public contact
Name of contact person
1st name Mizue
Middle name
Last name suzuki
Organization Hamamatsu University School of Medicine
Division name Faculty of Nursing
Zip code 431-3192
Address Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL 053-435-2826
Homepage URL
Email mizuesuzuki@gmail.com

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
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 Hamamatsu University School of Medicine
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
Tel 053-435-2826
Email m~suzuki@hama-med.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
2020 Year 09 Month 01 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
2020 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2023 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
2020 Year 08 Month 25 Day
Last modified on
2020 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047431

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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