UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033814
Receipt number R000038567
Scientific Title The Intervention study for Medication assist provided by pharmacist for the elderly with polypharmacy (1)
Date of disclosure of the study information 2018/10/01
Last modified on 2019/03/13 12:44:36

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Basic information

Public title

The Intervention study for Medication assist provided by pharmacist for the elderly with
polypharmacy (1)

Acronym

IMPROVE study (The Intervention study for medication assist provided by pharmacist for the elderly with polypharmacy)

Scientific Title

The Intervention study for Medication assist provided by pharmacist for the elderly with
polypharmacy (1)

Scientific Title:Acronym

IMPROVE study (The Intervention study for medication assist provided by pharmacist for the elderly with polypharmacy)

Region

Japan


Condition

Condition

Polypharmacy

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of outcome by pharmacist's intervention on polypharmacy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Number of drugs prescribed

Key secondary outcomes

Number of PIMs prescribed
Patient proportion who was reduced one or more medication without problems
Patient proportion who was reduced one or more PIM without problems
Medication adherence
ADL score
Frequency of occurrence of drug adverse events
Quality of Life score
Drug cost


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Behavior,custom

Interventions/Control_1

Prescription review for deprescribing by pharmacist-led Multi-occupation collaboration

Interventions/Control_2

Usual care

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

Person who taking more than 5 medications
Person who agree to participate in the research

Key exclusion criteria

Cancer (palliative care) patients
Psychiatric disorders
Patients who have already reviewed the prescription
Patients judged inappropriate by the facility manager

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Mitsuko
Middle name
Last name Onda

Organization

Osaka University of Pharmaceutical Sciences

Division name

Department of Social and Administrative Pharmacy

Zip code

569-1041

Address

4-20-1 Nasahara, Takatsuki, Osaka

TEL

+81-72-690-1059

Email

onda@gly.oups.ac.jp


Public contact

Name of contact person

1st name Mitsuko
Middle name
Last name Onda

Organization

Osaka University of Pharmaceutical Sciences

Division name

Department of Social and Administrative Pharmacy

Zip code

569-1041

Address

4-20-1 Nasahara, Takatsuki, Osaka

TEL

+81-72-690-1059

Homepage URL


Email

onda@gly.oups.ac.jp


Sponsor or person

Institute

Osaka University of Pharmaceutical Sciences

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka University of Pharmaceutical Sciences

Address

4-20-1, Nasahara, Takatsuki, Osaka, Japan

Tel

+81-72-690-1103

Email

kenkyus@gly.oups.ac.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



Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 01 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

55

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

2018 Year 03 Month 09 Day

Date of IRB

2018 Year 03 Month 09 Day

Anticipated trial start date

2018 Year 03 Month 09 Day

Last follow-up date

2019 Year 01 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 20 Day

Last modified on

2019 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038567


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name