UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024680 |
|---|---|
| Receipt number | R000027710 |
| Scientific Title | Therapeutic approach in elderly patients with polypharmacy by medical team: Prospective observational study |
| Date of disclosure of the study information | 2016/11/02 |
| Last modified on | 2020/05/06 09:15:15 |
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Basic information
Public title
Therapeutic approach in elderly patients with polypharmacy by medical team: Prospective observational study
Acronym
Polypharmacy reduction observational study
Scientific Title
Therapeutic approach in elderly patients with polypharmacy by medical team: Prospective observational study
Scientific Title:Acronym
Polypharmacy reduction observational study
Region
| Japan |
Condition
Condition
Polypharmacy
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety evaluation for reducing drugs
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate safety for the difference in the incidence of adverse drug reactions that polypharmacy patients (more than 5 agents) with the potentially inappropriate medications.
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
1 Patients can ensure more than 2 weeks from observation initiation
2 Patients recieve 5 or more medications from 4 weeks ago
3 Patient can consent by a document
Key exclusion criteria
1 Patient whose cannot consent in writing at the impact of dementia
2 Patients whose participation is deemed inappropriate at the discretion of the attending physician
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Arai |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Gerontology and Social Science
Zip code
4748511
Address
7-430 Morioka, Obu, Aichi 474-8511, Japan
TEL
0562-46-2311
harai@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Fumihiro |
| Middle name | |
| Last name | Mizokami |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Pharmacy
Zip code
4748511
Address
7-430 Morioka, Obu, Aichi 474-8511, Japan
TEL
0562-46-2311
Homepage URL
mizokami@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
the Comprehensive Research on Aging and Health from the Japan Agency for Medical Research and Development (AMED)
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
National Center for Geriatrics and Gerontology
Address
7-430 Morioka, Obu, Aichi 474-8511, Japan
Tel
0562462311
mizokami@ncgg.go.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
国立長寿医療研究センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 02 | 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
500
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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
All patients who admitted in National center for geriatrics and gerontology and meet the selection criteria from September 2016 to May 2019.
Management information
Registered date
| 2016 | Year | 11 | Month | 02 | Day |
Last modified on
| 2020 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027710
