UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054392 |
|---|---|
| Receipt number | R000062126 |
| Scientific Title | Health Impact of a Comprehensive Approach for Community Elderly Residents (Including Diabetes) |
| Date of disclosure of the study information | 2024/05/17 |
| Last modified on | 2024/05/14 12:16:41 |
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Basic information
Public title
Health Impact of a Comprehensive Approach for Community Elderly Residents (Including Diabetes)
Acronym
Impact of health policies on local aging society (including diabetes)
Scientific Title
Health Impact of a Comprehensive Approach for Community Elderly Residents (Including Diabetes)
Scientific Title:Acronym
Impact of health policies on local aging society (including diabetes)
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Impact of Health Policies on Community Health
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement effect on HbA1c
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
14 weeks of gym and brain function improvement courses regarding exercise, learning, and education.
Interventions/Control_2
Nothing for 14 weeks
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Residents over 60 years old who wish to participate in Miyaki-cho's "Kenko Daigaku" project.
Key exclusion criteria
Those deemed inappropriate as research subjects by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | shinichiro |
| Middle name | - |
| Last name | miura |
Organization
Fukuoka University Hospital
Division name
Cardiovascular Medicine
Zip code
814-0180
Address
Nanakuma, Jonan-ku, Fukuoka City, Fukuoka Prefecture
TEL
0928011011
yutarisou@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | - |
| Last name | Ibayahshi |
Organization
Fukuoka Heart Net Hospital
Division name
Internal medicine
Zip code
8190002
Address
2-2-50, Niece-nohama, Nishi-ku, Fukuoka City, Fukuoka Prefecture
TEL
092-881-0536
Homepage URL
yutarisou@gmail.com
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Foundation for Comprehensive Health Promotion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nanakuma, Jonan-ku, Fukuoka City, Fukuoka 814-0133, Japan
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka 814-0133, Japan
Tel
092-881-0536
tsujiyama@fukuoka-u.ac.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
| 2024 | Year | 05 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2024 | Year | 05 | Month | 14 | Day |
Last modified on
| 2024 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062126
