UMIN-CTR Clinical Trial

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