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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024680
Receipt No. 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 2016/11/02

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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
Middle name
Last name Hidenori arai
Organization National Center for Geriatrics and Gerontology
Division name Center for Gerontology and Social Science
Zip code
Address 7-430 Morioka, Obu, Aichi 474-8511, Japan
TEL 0562-46-2311
Email harai@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiro Mizokami
Organization National Center for Geriatrics and Gerontology
Division name Department of Pharmacy
Zip code
Address 7-430 Morioka, Obu, Aichi 474-8511, Japan
TEL 0562-46-2311
Homepage URL
Email mizokami@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Address
Tel
Email

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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 06 Day
Date of IRB
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
2016 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027710

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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