UMIN-CTR Clinical Trial

Basic information
Public title	A randomized, crossover, controlled Japanese trial examining the use of electronic Patient-Reported Outcomes to improve medication adherence by outpatient Pharmacists.
Acronym	JPRO-P
Scientific Title	A randomized, crossover, controlled Japanese trial examining the use of electronic Patient-Reported Outcomes to improve medication adherence by outpatient Pharmacists.
Scientific Title:Acronym	JPRO-P
Region	Japan

Condition
Condition	Atrial fibrillation, Venous thromboembolism
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Improve adherence through pharmacist counseling and use of electronic patient-reported outcomes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Medication adherence rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Fill out the electronic patient-reported outcome(ePRO) daily for medications and side effects during first month. Take medication as usual for next month without ePRO.
Interventions/Control_2	Take medication as usual for first month without ePRO. Fill out the ePRO daily for medications and side effects during next month.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who are taking anticoagulants (warfarin, dabigatran, edoxaban, rivaroxaban, apixaban). 2) Patients who are able to use a cell phone or computer. 3) Patients who have received sufficient explanation and understanding of the study, and have given their free written consent to participate in this study.
Key exclusion criteria	1) Patients who were judged by the physician in charge to be inappropriate as subjects. 2) In addition, patients who were judged by Principal Investigator to be unsuitable for participation in this study.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Rie Middle name Last name Ozeki
Organization	Juntendo University
Division name	School of Medicine Breast Oncology
Zip code	113-8421
Address	2-1-1, Hongo Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	r.ozeki.gs@juntendo.ac.jp

Public contact
Name of contact person	1st name Rie Middle name Last name Ozeki
Organization	Juntendo Univerity
Division name	School of Medicine Breast Oncology
Zip code	113-8421
Address	2-1-1, Hongo Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	r.ozeki.gs@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Grants-in-Aid Scientific Research
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Cardiovascular Medicine, Juntendo University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Juntendo University
Address	3-1-3, Hongo Bunkyo-ku, Tokyo
Tel	03-5802-1584
Email	kenkyu5858@juntendo.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	2021 Year 02 Month 16 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	Preinitiation
Date of protocol fixation	2020 Year 11 Month 24 Day
Date of IRB	2020 Year 12 Month 04 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 15 Day
Last modified on	2021 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049244

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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