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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000010325
Receipt No. R000012086
Scientific Title A Randomized Controlled Trial of a Functioning Improved Tool home visit program for Japanese frail older people
Date of disclosure of the study information 2013/03/27
Last modified on 2015/03/02

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Basic information
Public title A Randomized Controlled Trial of a Functioning Improved Tool home visit program for Japanese frail older people
Acronym Preventive Home Visits: Hokkaido Study 3
Scientific Title A Randomized Controlled Trial of a Functioning Improved Tool home visit program for Japanese frail older people
Scientific Title:Acronym Preventive Home Visits: Hokkaido Study 3
Region
Japan

Condition
Condition Dementia
Depression
Disuse syndrome
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effects of a Functional Improvement Tool home visit program for older people
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes cognitive function
Key secondary outcomes Depressive status
Activities of Daily Living

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Functioning Improvement Tool home visit program
Interventions/Control_2 Home visits that included general conversations
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. Living at Takikawa city, Hokkaio, Japan
2. Frail elderly according to Japan Long Term Care system
3. Single or couple households
Key exclusion criteria Mini-Mental State Examination score: <18
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigekazu Ukawa
Organization Hokkaido University Graduate School of Medicine
Division name Department of Public Health
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638
TEL +81-11-706-5068
Email s-ukawa@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigekazu Ukawa
Organization Hokkaido University Graduate School of Medicine
Division name Department of Public Health
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638
TEL +81-11-706-5068
Homepage URL
Email s-ukawa@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization NIPPONKOA WELFARE FOUNDATION
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 03 Month 27 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 Completed
Date of protocol fixation
2013 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 27 Day
Last modified on
2015 Year 03 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012086

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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