UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019473
Receipt number R000022443
Scientific Title Comparison of knowledge integration-oriented clinical practice and experience-oriented Clinical Clerkship
Date of disclosure of the study information 2015/10/23
Last modified on 2019/10/25 10:26:38

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Basic information

Public title

Comparison of knowledge integration-oriented clinical practice and experience-oriented Clinical Clerkship

Acronym

Effect of the clinical clerkship

Scientific Title

Comparison of knowledge integration-oriented clinical practice and experience-oriented Clinical Clerkship

Scientific Title:Acronym

Effect of the clinical clerkship

Region

Japan


Condition

Condition

Healthy young persons

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to clarify the effects of students' self-assessments in their affective domain in knowledge integration-oriented clinical practice and experience-oriented clinical practice.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

General Self Efficacy Scale: GSES.

The evaluation period in all items.
Intervention before evaluation is carried out within two weeks.
Post-intervention evaluation is carried out within two weeks.

Key secondary outcomes

Profile of Mood States: POMS.
A self-assessment questionnaire with 70 items.
Questionnaire of VAS format.

The evaluation period in all items.
Intervention before evaluation is carried out within two weeks.
Post-intervention evaluation is carried out within two weeks.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Clinical practice with an emphasis on experience (Clinical Clerkship)

Interventions/Control_2

Clinical practice with an emphasis on knowledge integration

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

20 years-old <=

Age-upper limit

30 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy young persons

Key exclusion criteria

Mental illness
Depression
Emotional turmoil

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Tomonori
Middle name
Last name Yasuda

Organization

Kumamoto Health Science University

Division name

Department of Rehabilitation

Zip code

861-5598

Address

325 Izumi-machi, Kita-ku, Kumamoto 861-5598, Japan

TEL

096-275-2111

Email

t-yasuda@kumamoto-hsu.ac.jp


Public contact

Name of contact person

1st name Tomonori
Middle name
Last name Yasuda

Organization

Kumamoto Health Science University

Division name

Department of Rehabilitation

Zip code

861-5598

Address

325 Izumi-machi, Kita-ku, Kumamoto 861-5598, Japan

TEL

096-275-2111

Homepage URL


Email

t-yasuda@kumamoto-hsu.ac.jp


Sponsor or person

Institute

Kumamoto Health Science University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kumamoto Health Science University

Address

325 Izumi-machi, Kita-ku, Kumamoto 861-5598, Japan

Tel

096-275-2111

Email

t-yasuda@kumamoto-hsu.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

2015 Year 10 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

83

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

2015 Year 06 Month 25 Day

Date of IRB

2015 Year 06 Month 25 Day

Anticipated trial start date

2015 Year 06 Month 25 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 10 Month 23 Day

Last modified on

2019 Year 10 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022443


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name