UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042565 |
|---|---|
| Receipt number | R000048587 |
| Scientific Title | Effects of mailing program for preventing frailty on health behavior among community-dwelling older adults |
| Date of disclosure of the study information | 2020/11/26 |
| Last modified on | 2024/10/29 01:05:26 |
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Basic information
Public title
Effects of mailing program for preventing frailty on health behavior among community-dwelling older adults
Acronym
Effects of mailing program for preventing frailty
Scientific Title
Effects of mailing program for preventing frailty on health behavior among community-dwelling older adults
Scientific Title:Acronym
Effects of mailing program for preventing frailty
Region
| Japan |
Condition
Condition
Mental health and social network
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a mailing program on lifestyle and social network in older adults who participate in self-management social group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mental health and social network
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise, various food intake, and social interaction program by mailing materials
Interventions/Control_2
usual lifestyle
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons aged 65 years and older who participate in self-management groups
Key exclusion criteria
Those who are restricted from exercising by a doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | Seino |
| Last name | Seino |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Social Participation and Community Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi, Tokyo
TEL
0339643241
seino@tmig.or.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Seino |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Social Participation and Community Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi, Tokyo
TEL
0339643241
Homepage URL
seino@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ota City, Tokyo
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute of Gerontology Institutional Review Board
Address
35-2 Sakae-cho, Itabashi
Tel
03-3964-3241
naomi_hasegawa@tmghig.jp
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
| 2020 | Year | 11 | Month | 26 | 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
163
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
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048587
