UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022717 |
|---|---|
| Receipt number | R000026173 |
| Scientific Title | Analysis of the Evidence-practice Gap to Facilitate Proper Medical Care for the Elderly: Investigation, using Databases, of Utilization Measures for National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) in the Kyoto University Onsite Center |
| Date of disclosure of the study information | 2016/06/13 |
| Last modified on | 2016/12/13 09:50:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of the Evidence-practice Gap to Facilitate Proper Medical Care for the Elderly: Investigation, using Databases, of Utilization Measures for National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) in the Kyoto University Onsite Center
Acronym
Analysis of the evidence-practice gap for the elderly using NDB in Japan
Scientific Title
Analysis of the Evidence-practice Gap to Facilitate Proper Medical Care for the Elderly: Investigation, using Databases, of Utilization Measures for National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) in the Kyoto University Onsite Center
Scientific Title:Acronym
Analysis of the evidence-practice gap for the elderly using NDB in Japan
Region
| Japan |
Condition
Condition
Medical practice for elderly people (potentially inappropriate medication (PIMs), cancer, chronic kidney disease, end-of-life care)
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Nephrology |
| Geriatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify evidence-practice gaps in elderly patients in Japan
Basic objectives2
Others
Basic objectives -Others
To clarify gaps between practice and evidence in PIMs, Cancer, CKD and end-of-life care
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency and newly prescription rate of PIMs and quality and cost of cancer, CKD and end-of-life care
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have visited hospitals in Japan since April 2009
Key exclusion criteria
Patients with rare disease of which the number is less than 10 in the database
Target sample size
20000000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeo Nakayama |
Organization
Kyoto University
Division name
Graduate School of Medicine/School of Public Health
Zip code
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-9477
nakayama.takeo.4a@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | In charge of Conflict of Interest |
Organization
Kyoto University
Division name
Department of General Affairs and Human Resources, Graduate School of Medicine
Zip code
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-4305
Homepage URL
060rieki-sohan@mail2.adm.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
| 2016 | Year | 06 | Month | 13 | 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
| 2016 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Cross-sectional
Subjects: Patients who were registered in National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) and satisfied the criteria
Management information
Registered date
| 2016 | Year | 06 | Month | 13 | Day |
Last modified on
| 2016 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026173
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
