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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name