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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038200
Receipt No. 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 2021/04/05

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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
Email 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
Email mana-t@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

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
Email 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 No longer recruiting
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
2021 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043530

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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