UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048379 |
|---|---|
| Receipt number | R000055139 |
| Scientific Title | Training of highly skilled pharmacists enabling to contribute to disease prevention through atrial fibrillation screening I (Basic training) |
| Date of disclosure of the study information | 2022/07/14 |
| Last modified on | 2025/01/14 10:09:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Training of highly skilled pharmacists enabling to contribute to disease prevention through atrial fibrillation screening I (Basic training)
Acronym
Training of highly skilled pharmacists enabling to contribute to disease prevention through atrial fibrillation screening I (Basic training)
Scientific Title
Training of highly skilled pharmacists enabling to contribute to disease prevention through atrial fibrillation screening I (Basic training)
Scientific Title:Acronym
Training of highly skilled pharmacists enabling to contribute to disease prevention through atrial fibrillation screening I (Basic training)
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Japan's population is rapidly aging, and problems surrounding healthcare are piling up, such as increasing medical and nursing care costs and a shortage of physicians. As one of the solutions, pharmacists are required to participate in the field of disease prevention. However, there are few opportunities for pharmacy students and pharmacists to be actively involved in the field of disease prevention, and no educational methods have been established. It is one of the missions of the Faculty of Pharmacy to educate and produce highly qualified, leading pharmacists of the next generation who can respond to such changes in the healthcare situation.
The Nagasaki University School of Pharmacy, in cooperation with the University of New Mexico and the Nagasaki Pharmaceutical Association, has implemented a training program on atrial fibrillation for pharmacy students and pharmacy pharmacists to provide basic knowledge of arrhythmia and its treatment, and to improve clinical judgment skills in arrhythmia such as ECG interpretation and recommendation for consultation. The training will be conducted and its effectiveness will be verified.
Basic objectives2
Others
Basic objectives -Others
Sharing clinical education methods for pharmacy students and pharmacists with the University of New Mexico School of Pharmacy, which supports the health of local residents, will enable the development of highly clinically competent pharmacists in Japan.
In 2019, Nagasaki University School of Pharmacy, in collaboration with the Nagasaki Pharmaceutical Association, implemented a student-led arrhythmia screening event that introduced the New Mexico model. The screening event used an Omron portable electrocardiograph to detect two subjects with abnormal pulse rates out of 40 subjects. The questionnaire survey suggested that subjects and pharmacy students found this arrhythmia screening event useful as a pharmacist education program. However, since this screening event only identified abnormalities based on the messages displayed on the portable electrocardiograph, there is a need for improvement if it is to be implemented as a highly qualified pharmacist training program in the future.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Atrial Fibrillation Comprehension Test and Self-Assessment Questionnaire will be administered to the study subjects periodically before the training program and thereafter at pre-screening event timing, i.e., approximately every six months. Researchers will analyze changes in test results and self-assessments.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Fourth and fifth year students of the Nagasaki University Faculty of Pharmaceutical Sciences (those who have obtained a pharmacist license)
1st, 2nd, and 3rd year students of the Doctoral Program of the Nagasaki University Graduate School of Biomedical Sciences (licensed pharmacists and those planning to become licensed pharmacists)
Community pharmacists in Nagasaki Prefecture
Key exclusion criteria
non
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mana |
| Middle name | |
| Last name | Miyakoda |
Organization
Nagasaki University
Division name
School of Pharmaceutical Sciences
Zip code
852-8521
Address
1-14 Bunkyo-machi, Nagasaki City
TEL
095-819-2456
mana-t@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mana |
| Middle name | |
| Last name | Miyakoda |
Organization
Nagasaki University
Division name
School of Pharmaceutical Sciences
Zip code
852-8521
Address
1-14 Bunkyo-machi, Nagasaki City
TEL
095-819-2456
Homepage URL
mana-t@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Pfizer Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Graduate School of Biomedical Science
Address
1-12-4 Sakamoto-machi, Nagasaki City
Tel
095-819-7198
gakujutu_gakuji@ml.nagasaki-u.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
| 2022 | Year | 07 | Month | 14 | 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
| 2022 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe the change in the rate of scoring on the Atrial Fibrillation Comprehension Test.
We observe the rate of increase in self-assessment questionnaires.
Management information
Registered date
| 2022 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055139
