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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024811
Receipt No. R000028553
Scientific Title An interventional study to examine the effect of shared decision making in a family on intention of HPV vaccination in order to protect Japanese girls from HPV due to the low coverage of the vaccination and excess of mothers' responsibility to make a decision.
Date of disclosure of the study information 2016/11/12
Last modified on 2019/05/08

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Basic information
Public title An interventional study to examine the effect of shared decision making in a family on intention of HPV vaccination in order to protect Japanese girls from HPV due to the low coverage of the vaccination and excess of mothers' responsibility to make a decision.
Acronym Shared decision making in a family on intention of HPV vaccination
Scientific Title An interventional study to examine the effect of shared decision making in a family on intention of HPV vaccination in order to protect Japanese girls from HPV due to the low coverage of the vaccination and excess of mothers' responsibility to make a decision.
Scientific Title:Acronym Shared decision making in a family on intention of HPV vaccination
Region
Japan

Condition
Condition Cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of the study is to examine the effect of shared decision making in a family with decision aids on improvement in intention of the HPV vaccination.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intention to vaccinate young females
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 The one group will be instructed to involve their husband in the discussion with newly created decision aid materials as well as the promotional leaflet. These materials and the questionnaire will be delivered by mail.
Interventions/Control_2 The control group of people will be mailed with only leaflet of vaccination promotion.
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
12 years-old <=
Age-upper limit
18 years-old >=
Gender Female
Key inclusion criteria The target population is married mothers whose daughters must be from 12 to 18 years old.
Key exclusion criteria The criteria of exclusion into the study is that their daughters have already had experience of HPV vaccination.
Target sample size 900

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Kimura
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita
TEL 06-6879-3351
Email tadashi@gyne.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Tanaka
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita
TEL 06-6879-3351
Homepage URL
Email ytanaka-jun@umin.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Investigator Studies Program by Merck & Co.
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
Address
Tel
Email

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
2016 Year 11 Month 12 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
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
2016 Year 05 Month 31 Day
Date of IRB
2016 Year 11 Month 14 Day
Anticipated trial start date
2016 Year 11 Month 21 Day
Last follow-up date
2019 Year 05 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 12 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028553

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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