UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012037 |
|---|---|
| Receipt number | R000014069 |
| Scientific Title | Development And Validation Of Comprehensive Care Program For Secondary Prevention In Obu City – In terms of physical, oral and nutritional function- |
| Date of disclosure of the study information | 2013/10/31 |
| Last modified on | 2013/10/15 14:22:52 |
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Basic information
Public title
Development And Validation Of Comprehensive Care Program For Secondary Prevention In Obu City – In terms of physical, oral and nutritional function-
Acronym
Secondary Prevention for Kihon Check-list in Obu city
Scientific Title
Development And Validation Of Comprehensive Care Program For Secondary Prevention In Obu City – In terms of physical, oral and nutritional function-
Scientific Title:Acronym
Secondary Prevention for Kihon Check-list in Obu city
Region
| Japan |
Condition
Condition
Frailty older people
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of comprehensive intervention program to improve physical function and maintain independent living among older adults that need primary and secondary prevention for prevention of long-term care state decided by Kihon Check-list
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Range of life space, physical activity
Key secondary outcomes
Physical function, oral function, state of nutrition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Comprehensive program which improve physical and oral function and nutrition status
Interventions/Control_2
Control group: non-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
Applied to primal prevention or secondary prevention in health check-up questionnaire (Kihon Check-list) made by ministry of Health, Labour and Welfare of Japan
Key exclusion criteria
1) Have serious or unstable illnesses
2) Have difficulty in gait
3) Participant in other studies
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suzuki Takao |
Organization
National Center for Geriatrics and Gerontology
Division name
Research Institute
Zip code
Address
35 Gengo, Morioka-machi, Obu, Aichi, 474-8511, Japan
TEL
0562871285
suzutaka@ncgg.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shimada Hiroyuki |
Organization
National Center for Geriatrics and Gerontology
Division name
Section for Health Promotion, Department for Research and Development to Support Independent Life of
Zip code
Address
35 Gengo, Morioka-machi, Obu, Aichi, 474-8511, Japan
TEL
0562871285
Homepage URL
shimada@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Obu City Office
Organization
Division
Category of Funding Organization
Local Government
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
| 2013 | Year | 10 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 15 | Day |
Last modified on
| 2013 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014069
