UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000038474
Receipt No. R000042864
Scientific Title Development of day service for elderly people requiring mild care and independence support program that can be continued at home
Date of disclosure of the study information 2019/11/05
Last modified on 2019/11/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Development of day service for elderly people requiring mild care and independence support program that can be continued at home
Acronym Development of day service for elderly people requiring mild care and independence support program that can be continued at home
Scientific Title Development of day service for elderly people requiring mild care and independence support program that can be continued at home
Scientific Title:Acronym Development of day service for elderly people requiring mild care and independence support program that can be continued at home
Region
Japan

Condition
Condition People Certified for Long-Term
requiring support 1 or 2
Requiring long-term care 1
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the feasibility and usefulness of the independence support program for the needy supporters supported by the day care staff
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes walking speed (5m)
Behfore intervention, After intervention(8weeks later)
Key secondary outcomes Geriatric Depression Scale Japan
Time up go
Mini-Mental State Examination
Behfore intervention, After intervention(8weeks later)

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
Behavior,custom
Interventions/Control_1 Target elderly perform daily hor 8weeks
Rise frome the chair 10times/day
walking 30minutes/day
write a diary every day
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)More than 3 months use of day care use
Requiring support 1or2
Requiring long-term care1
Key exclusion criteria Person who can not writeI can not write
People with an MMSE of 21 or less
People with hearing loss
Person who did not obtain written consent
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yumi
Middle name
Last name Fukaya
Organization University of Human Envuronments
Division name Department of Nursing,Graduate School of University of Human Environments
Zip code 474-0035
Address 3-220,Ebaata-cho,Obu-City,Aichi,Japan
TEL 0562-43-0701
Email dn16007@uhe.ac.jp

Public contact
Name of contact person
1st name Yumi
Middle name
Last name Fukaya
Organization University of Human Envuronments
Division name Graduate School of University of Human Environments
Zip code 474-0035
Address 3-220,Ebaata-cho,Obu-City,Aichi,Japan
TEL 0562-43-0701
Homepage URL
Email dn16007@uhe.ac.jp

Sponsor
Institute University of Human Envuronments
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Human Envuronments
Address 3-220,Ebaata-cho,Obu-City,Aichi,Japan
Tel 0562-43-0701
Email dn16007@uhe.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
2019 Year 11 Month 05 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 Suspended
Date of protocol fixation
2017 Year 06 Month 11 Day
Date of IRB
2017 Year 09 Month 19 Day
Anticipated trial start date
2017 Year 11 Month 10 Day
Last follow-up date
2019 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 02 Day
Last modified on
2019 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042864

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.