UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004767 |
|---|---|
| Receipt number | R000005674 |
| Scientific Title | Effect of Preventive Home Visits for the Elderly -the Functioning Improvement Tool vs. daily conversation -: a randomized, controlled Trial |
| Date of disclosure of the study information | 2010/12/21 |
| Last modified on | 2011/06/21 10:04:59 |
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Basic information
Public title
Effect of Preventive Home Visits for the Elderly -the Functioning Improvement Tool vs. daily conversation -: a randomized, controlled Trial
Acronym
Preventive Home Visits: Hokkaido study (2)
Scientific Title
Effect of Preventive Home Visits for the Elderly -the Functioning Improvement Tool vs. daily conversation -: a randomized, controlled Trial
Scientific Title:Acronym
Preventive Home Visits: Hokkaido study (2)
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
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Usual activity
Depression
Cognitive function
Key secondary outcomes
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
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Preventive home visits using the Functioning Improvement Tool for senior citizen
Interventions/Control_2
Home visits with daily conversation
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
3. subjects participated in Hokkaido preventive home visit study and allocated to control group
Key exclusion criteria
None
Target sample size
50
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
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
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine Department of Public Health Sciences
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 12 | Month | 21 | 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
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 21 | Day |
Last modified on
| 2011 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005674
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
