UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007955 |
|---|---|
| Receipt number | R000008442 |
| Scientific Title | Trial examining the efficacy of the list of potentiall inappropriate medications in long-term care facilities |
| Date of disclosure of the study information | 2012/05/15 |
| Last modified on | 2017/05/20 21:31:38 |
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Basic information
Public title
Trial examining the efficacy of the list of potentiall inappropriate medications in long-term care facilities
Acronym
Trial examining the efficacy of the PIM list
Scientific Title
Trial examining the efficacy of the list of potentiall inappropriate medications in long-term care facilities
Scientific Title:Acronym
Trial examining the efficacy of the PIM list
Region
| Japan |
Condition
Condition
Residents of geriatric health service facilities
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of decreasing the clinical events by applying the Japanese version of the Beers list to the residents of geriatric health service facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurence of acute illness or acute exaggeration of chronic disease in 3 months after admission.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Prescribing drugs to residents of long term care facilities by using the the Japanese version of Beers list as reference at admission.
Interventions/Control_2
Prescribe drugs to residents of long term care facilities at admission as usual.
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
Consecutive admitting residents aged 65 years or older.
Key exclusion criteria
1. Residents of scheduled short-term placement
2. Residents who have history of placement to the same facility within last 6 months.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Akishita |
Organization
The University of Tokyo
Division name
Department of Geriatric Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8652
akishita-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Akishita |
Organization
The University of Tokyo
Division name
Department of Geriatric Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8652
Homepage URL
akishita-tky@umin.ac.jp
Sponsor or person
Institute
Study group for appropriate medical services for the elderly
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
YES
Study ID_1
9
Org. issuing International ID_1
Japan Association of Geriatric Health Services Facilities
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 15 | Day |
Last modified on
| 2017 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008442
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/05/20 | s1-ln22256803374533453-1939656818Hwf550412600IdV75771585322256803PDF_HI0001.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
