UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054452 |
|---|---|
| Receipt number | R000062140 |
| Scientific Title | Trial of Pregnancy and Medication Counseling Education Targeting 6th-Year Pharmacy Students in Japan: A Pilot Study Examining Effective Implementation Methods and Identifying Challenges for Evaluating Educational Effectiveness |
| Date of disclosure of the study information | 2024/05/21 |
| Last modified on | 2025/05/22 16:01:35 |
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Basic information
Public title
A pilot study of pregnancy and drug counseling education for 6th-year pharmacy students
Acronym
Pregnancy and Drug Counseling Education for Pharmacy Students
Scientific Title
Trial of Pregnancy and Medication Counseling Education Targeting 6th-Year Pharmacy Students in Japan: A Pilot Study Examining Effective Implementation Methods and Identifying Challenges for Evaluating Educational Effectiveness
Scientific Title:Acronym
A Pilot Study of Pregnancy and Medication Counseling Education for Pharmacy Students
Region
| Japan |
Condition
Condition
Sixth-year pharmacy students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Provide opportunities for sixth-year pharmacy students to learn the basic knowledge, skills, and attitudes needed to perform consultation services related to pregnancy and medication as pharmacists.
2. To evaluate the effectiveness of the education using the differences in scores in questionnaires completed before and after the exercise and to obtain helpful data to consider future education methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the difference between the scores of the 5-point scale questionnaires that were answered before and after providing education.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Pregnancy and medication workshop
Interventions/Control_2
Another workshop
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Sixth-year students who elect the Hospital Pharmacy Course at the Department of Pharmacy, School of Pharmaceutical Sciences, Meiji Pharmaceutical University in the academic year 2024.
Key exclusion criteria
Students who do not agree to participate in this study.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Akimasa |
| Middle name | |
| Last name | Yamatani |
Organization
Meiji Pharmaceutical University
Division name
Department of Clinical Pharmacy / Pediatric and Perinatal Pharmacology
Zip code
204-8588
Address
2-522-1 Noshio, Kiyose Tokyo Japan
TEL
042-495-8948
yamatani-a@my-pharm.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Nagai |
Organization
Meiji Pharmaceutical University
Division name
The Office of Institutional Research
Zip code
204-8588
Address
2-522-1 Noshio, Kiyose Tokyo Japan
TEL
042-495-8819
Homepage URL
nagai-j@my-pharm.ac.jp
Sponsor or person
Institute
Meiji Pharmaceutical University
Institute
Department
Personal name
Akimasa Yamatani
Funding Source
Organization
Meiji Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Japan Drug Information Institute in Pregnancy, National Center for Child Health and Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Secretariat of Institutional Review Board at Meiji Pharmaceutical University
Address
2-522-1 Noshio, Kiyose Tokyo Japan
Tel
042-495-8624
kenkyu-r@my-pharm.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
明治薬科大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 21 | 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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062140
