UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Takeo Nakayama
Organization	Kyoto University
Division name	Graduate School of Medicine/School of Public Health
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9477
Email	nakayama.takeo.4a@kyoto-u.ac.jp

Public contact
Name of contact person	In charge of Conflict of Interest
Organization	Kyoto University
Division name	Department of General Affairs and Human Resources, Graduate School of Medicine
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-4305
Homepage URL
Email	060rieki-sohan@mail2.adm.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026173