UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026515 |
|---|---|
| Receipt number | R000030451 |
| Scientific Title | A community-wide intervention trial for preventing or reducing frailty among older adults living in metropolitan areas |
| Date of disclosure of the study information | 2017/03/12 |
| Last modified on | 2018/09/13 09:46:43 |
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Basic information
Public title
A community-wide intervention trial for preventing or reducing frailty among older adults living in metropolitan areas
Acronym
A community-wide intervention trial for preventing frailty
Scientific Title
A community-wide intervention trial for preventing or reducing frailty among older adults living in metropolitan areas
Scientific Title:Acronym
A community-wide intervention trial for preventing frailty
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create a social mechanism (i.e., intervention content) that postpones frailty and examine its effectiveness.
Basic objectives2
Others
Basic objectives -Others
To examine the requirements for it to spread to other communities (transferability).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Check-List 15 score and prevalence of frailty (i.e. score of 4 and above)
Key secondary outcomes
Physical activity and physical function
Dietary variety
Social activity and psychosocial function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention/the interventions that focus on improving dietary variety and physical and social activities will be conducted with respect to each intervention cluster as participatory action research.
Interventions/Control_2
Control/usual health practices will be conducted.
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
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 65-84 years old living in Ota City, Tokyo.
Key exclusion criteria
Individual with long-term care insurance certification and those admitted to hospitals or residing in nursing homes were excluded.
Target sample size
15500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Shinkai |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Vice director
Zip code
Address
35-2 Sakae-cho, Itabashi, Tokyo
TEL
03-3964-3241
sshinkai@tmig.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naomi Hasegawa |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Corporate Planning department
Zip code
Address
35-2 Sakae-cho, Itabashi, Tokyo
TEL
03-3964-3241
Homepage URL
naomi_hasegawa@tmghig.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ota City
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
| 2017 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 27 | 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
| 2017 | Year | 03 | Month | 12 | Day |
Last modified on
| 2018 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030451
| Research Plan | |
|---|---|
| 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 |
