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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003877
Receipt No. R000004669
Scientific Title Effect of Preventive Home Visits for the Elderly: a Randomized Control Trial
Date of disclosure of the study information 2010/07/06
Last modified on 2010/07/06

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Basic information
Public title Effect of Preventive Home Visits for the Elderly: a Randomized Control Trial
Acronym Preventive Home Visits: Hokkaido study
Scientific Title Effect of Preventive Home Visits for the Elderly: a Randomized Control Trial
Scientific Title:Acronym Preventive Home Visits: Hokkaido study
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study was to demonstrate the effects of preventive home visits using the Functioning Improvement Tool for senior citizen on usual activity, depression, and cognitive function among community-dwelling elderly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Usual activity
Depression
Cognitive function
Key secondary outcomes Subjective Health
General trust
Self efficacy

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Preventive home visits using the Functioning Improvement Tool for senior citizen
Interventions/Control_2 No intervention
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 home
2. Among frail seniors with requiring mild degree of support or care for daily activities from healthy seniors: seniors with three lowest levels in seven stages of certified long-term care levels according to Japan implemented mandatory social long-term care insurance system
Key exclusion criteria None
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoyuki Yuasa
Organization Juntendo University School of Medecine
Division name Department of Public Health
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hokkaido University Graduate School of Medicine
Division name Department of Public Health Sciences
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Hokkaido University Graduate School of Medicine Department of Public Health Sciences
Institute
Department

Funding Source
Organization Health, Labour and Welfare Ministry
Organization
Division
Category of Funding Organization
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
2010 Year 07 Month 06 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
2008 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 07 Month 01 Day
Date trial data considered complete
2009 Year 07 Month 01 Day
Date analysis concluded
2009 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 06 Day
Last modified on
2010 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004669

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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