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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031799
Receipt No. R000036301
Scientific Title The effect of the order made preventive care based on analyzing self-problems by local residences
Date of disclosure of the study information 2018/03/19
Last modified on 2019/10/16

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Basic information
Public title The effect of the order made preventive care based on analyzing self-problems by local residences
Acronym The preventive care based on analyzing self-problems
Scientific Title The effect of the order made preventive care based on analyzing self-problems by local residences
Scientific Title:Acronym The preventive care based on analyzing self-problems
Region
Japan

Condition
Condition frailty
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To inspect the effect of the order made preventive care based on analyzing self-problems by local residences
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the living conditions measured by the basic check list after four and ten months
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 the preventive care based on analyzing self-problems by participants
Interventions/Control_2 the conventional action in the local voluntary group
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 Man and woman 65 years or older participating the local voluntary group
Key exclusion criteria The elderly who has difficulty in exercise or in participating the local voluntary group
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Shinohara
Organization Takasaki University of Health and Welfare
Division name Department of Physical Therapy, Faculty of Health Care
Zip code 370-0033
Address 501, Nakaorui-machi, Takasaki-shi, Gunma
TEL 0273521291
Email shinohara-t@takasaki-u.ac.jp

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Shinohara
Organization Takasaki University of Health and Welfare
Division name Department of Physical Therapy, Faculty of Health Care
Zip code 370-0033
Address 501, Nakaorui-machi, Takasaki-shi, Gunma
TEL 0273521291
Homepage URL
Email shinohara-t@takasaki-u.ac.jp

Sponsor
Institute Takasaki University of Health and Welfare
Institute
Department

Funding Source
Organization Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research Ethics Committee, Takasaki University of Health and Welfare
Address 501, Nakaorui-machi, Takasaki-shi, Gunma
Tel 0273521291
Email mune@takasaki-u.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
2018 Year 03 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 56
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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 07 Day
Date of IRB
2017 Year 11 Month 07 Day
Anticipated trial start date
2017 Year 11 Month 20 Day
Last follow-up date
2018 Year 12 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
2018 Year 03 Month 19 Day
Last modified on
2019 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036301

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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