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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012037
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email shimada@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014069


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