UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055722 |
|---|---|
| Receipt number | R000063675 |
| Scientific Title | Risk Assessment of Major Amputation in Adults Aged 75 or Older in Japan utilizing administrative claims |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2024/10/03 13:55:07 |
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Basic information
Public title
Risk Assessment of Major Amputation in Adults Aged 75 or Older in Japan utilizing administrative claims
Acronym
Risk Assessment of Major Amputation in Adults Aged 75 or Older in Japan utilizing administrative claims
Scientific Title
Risk Assessment of Major Amputation in Adults Aged 75 or Older in Japan utilizing administrative claims
Scientific Title:Acronym
Risk Assessment of Major Amputation in Adults Aged 75 or Older in Japan utilizing administrative claims
Region
| Japan |
Condition
Condition
Lower extremity amputation
Classification by specialty
| Endocrinology and Metabolism | Geriatrics | Vascular surgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As major amputation is a serious complication that causes disability among older adults, this study aimed to identify factors associated with major amputation using administrative claims data.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Major amputations, either above or below the knee
Key secondary outcomes
Any amputation, foot amputation, toe amputation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 75 | years-old | <= |
Age-upper limit
| 200 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All residents residing in Hokkaido prefecture who have qualification of Long Life Medical Insurance
Key exclusion criteria
None
Target sample size
700000
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Handa |
Organization
Juntendo University, Graduate School of Medicine
Division name
Digital Therapeutics
Zip code
225-0014
Address
1-15-23, Eda-nishi, Aoba-ku Yokohama-shi, 225-0014 Kanagawa-ken, Japan
TEL
0454825269
nhanda111@gmail.com
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Handa |
Organization
Juntendo University, Graduate School of Medicine
Division name
Digital Therapeutics
Zip code
225-0014
Address
1-15-23, Eda-nishi, Aoba-ku Yokohama-shi, 225-0014 Kanagawa-ken, Japan
TEL
0454825269
Homepage URL
nhanda111@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Takumi Hirata
Funding Source
Organization
a Grant-in-Aid for Scientific Research (KAKENHI, No.: 24K13323.)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute of Gerontology
Address
35-2, Sakae-cyo, Itabashi-ku, Tokyo, Japan
Tel
0339643241
jinjik@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
| 2024 | Year | 10 | Month | 03 | 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
705538
Results
Results: Major amputations, either above or below the knee, were identified in 504 participants (0.07%) over 42 months of follow-up . The multi-variate analysis identified 11 factors associated with major amputation: chronic dialysis (Odds ratio]=10.27), stroke (1.60), ischemic heart disease (1.60), anemia (1.62), peripheral arterial disease (3.91), dementia (2.15), use of anti-coagulant (1.77 ), use of insulin (4.58), use of oral anti-hyperglycemic agent (1.68), use of statin (0.52), and male sex (1.28).
Results date posted
| 2024 | Year | 10 | Month | 03 | Day |
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 | 03 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The claims records under the LLMCS comprise hospital admission records, prescription records, claims related to outpatient visits, claims related to medical supplies used during treatment, and medical procedure records. As a single-payer of the local government-managed claims of the LLMCS, claims from multiple medical institutions and clinics, pharmacies, home-visit medical care, and other healthcare facilities covered by the LLMCS were integrated. These records contain information on the mortality and movement of residents out of Hokkaido Prefecture, which disqualified an individual from the LLMCS coverage. A complete set of LLMCS insurance claims data for all qualified residents in Hokkaido Prefecture was available from April 2016 to March 2020.
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063675
