UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042527
Receipt number R000048144
Scientific Title Feasibility study of an intervention program to enhance self-confidence of professionals who deal with radiation-related health concerns
Date of disclosure of the study information 2020/11/25
Last modified on 2021/05/25 22:20:57

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Basic information

Public title

Development of an intervention program to enhance "self-confidence in answering questions when asked" for professionals who consult or disseminate information about radiation-related health concerns examination of its feasibility

Acronym

Development of an intervention program to enhance "self-confidence in answering questions when asked" for professionals who consult or disseminate information about radiation-related health concerns examination of its feasibility

Scientific Title

Feasibility study of an intervention program to enhance self-confidence of professionals who deal with radiation-related health concerns

Scientific Title:Acronym

Feasibility study of an intervention program to enhance self-confidence of professionals who deal with radiation-related health concerns

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the feasibility of a "literacy enhancement program" targeting professionals that frequently receive consultations about radiation health concerns.

Basic objectives2

Others

Basic objectives -Others

Feasibility

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Feasibility
Impressions of the program (whether it was easy to participate in the program and participants recommend attendance to others.)

Key secondary outcomes

Radiation-related knowledge
Literacy


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Lecture 50minutes
Group Discussion 40minutes
Presentation 10minutes

Interventions/Control_2

Provision of materials

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

N/A

Key exclusion criteria

N/A

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Seiji
Middle name
Last name Yasumura

Organization

Fukushima Medical University

Division name

Department of Public Health

Zip code

960-1295

Address

1, Hikarigaoka, Fukushima

TEL

024-547-1180

Email

yasumura@fmu.ac.jp


Public contact

Name of contact person

1st name Seiji
Middle name
Last name Yasumura

Organization

Fukushima Medical University

Division name

Department of Public Health

Zip code

9601295

Address

1, Hikarigaoka, Fukushima

TEL

0245471180

Homepage URL


Email

yasumura@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

Fukushima Medical University

Address

1, Hikarigaoka, Fukushima

Tel

0245471825

Email

rs@fmu.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

2020 Year 11 Month 25 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

25

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

2020 Year 10 Month 23 Day

Date of IRB

2020 Year 11 Month 17 Day

Anticipated trial start date

2020 Year 11 Month 25 Day

Last follow-up date

2021 Year 01 Month 31 Day

Date of closure to data entry

2021 Year 02 Month 04 Day

Date trial data considered complete

2021 Year 04 Month 07 Day

Date analysis concluded

2021 Year 04 Month 07 Day


Other

Other related information



Management information

Registered date

2020 Year 11 Month 24 Day

Last modified on

2021 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048144


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name