UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043330 |
|---|---|
| Receipt number | R000049244 |
| Scientific Title | A randomized, crossover, controlled Japanese trial examining the use of electronic Patient-Reported Outcomes to improve medication adherence by outpatient Pharmacists. |
| Date of disclosure of the study information | 2021/02/16 |
| Last modified on | 2024/02/26 12:21:22 |
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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
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
r.ozeki.gs@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
100
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
No longer recruiting
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 | 06 | Month | 14 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049244
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
