UMIN-CTR Clinical Trial

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
Last 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
1st 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
Institute	Osaka University of Pharmaceutical Sciences
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038567