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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name