UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038200 |
|---|---|
| Receipt number | R000043530 |
| Scientific Title | Development of Curriculum for Community Medicine Based Screening for Arrhythmia |
| Date of disclosure of the study information | 2019/10/04 |
| Last modified on | 2022/10/06 13:07:39 |
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Basic information
Public title
Development of Curriculum for Community Medicine Based Screening for Arrhythmia
Acronym
Development of Curriculum for Community Medicine Based Screening for Arrhythmia
Scientific Title
Development of Curriculum for Community Medicine Based Screening for Arrhythmia
Scientific Title:Acronym
Development of Curriculum for Community Medicine Based Screening for Arrhythmia
Region
| Japan |
Condition
Condition
arrhythmia
Classification by specialty
| Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, a super-aging society has been developed, and advanced medical care and community medical care "healing and supporting medical care" have progressed in cooperation from hospital-centered "healing medical care". While advanced medical care is highly specialized for treatment of critically ill patients in advanced treatment hospitals, regional medical care such as disease prevention, mild illness treatment, and home care is based on community-institutions. Education and production of high-quality and leading next-generation pharmacists who can respond to such medical reforms is one of the major missions imposed on the faculty of pharmacy.
Recent progress in hospital training curriculums are remarkable, but on the other hand, there are few opportunities for students to be actively involved in disease prevention and health promotion of local residents, and there are few educational curricula to teach them. Therefore, the development of next-generation pharmacy education of community medicine curriculum is essential.
Since myocardial infarction and stroke facilitate mortality, screening is essential as part of disease prevention. In Japan, it is rare to have a health fair led by a student at the Faculty of Pharmaceutical Sciences, so the method of the health fair and clinical research methods based on the data obtained from the fair are not well known. The University of New Mexico, School of Pharmacy has already hosted many student-led health fairs that contribute to community medicine by screening for various diseases.
Therefore, in this project, a student-led health fair is held, and these methods are shared by the three organizations of the University of New Mexico, Nagasaki University, and the Nagasaki Prefectural Pharmacists Association.
Basic objectives2
Others
Basic objectives -Others
We investigate the prevalence of arrhythmia in Nagasaki citizens in the health fare.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A questionnaire survey will be conducted on subjects, students, pharmacists, and teachers who participated in cardiac arrhythmia screening events to investigate the benefits of this educational program.
We will analyze the prevalence rate of arrhythmia rate in Nagasaki citizens.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
No
Key exclusion criteria
No
Target sample size
384
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
Nagasaki University
Organization
Division
Category of Funding Organization
Other
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
| 2019 | Year | 10 | Month | 04 | 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
40
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
| 2019 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 04 | 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
Sunday, October 6, 2019, 12: 00-15: 00, a rapid test for arrhythmia will be conducted at Coco Square in Cocowalk-Nagasaki, a shopping mall in Mori-machi, Nagasaki City. We will analyze the prevalence of arrhythmia in Nagasaki citizens using the collected data. In addition, a questionnaire survey is conducted for pharmacists and pharmacy students to examine if this event is useful as a curriculum.
Management information
Registered date
| 2019 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043530
