UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053110 |
|---|---|
| Receipt number | R000060511 |
| Scientific Title | The effectiveness of health education-enhanced decision making program to get HPV vaccination for women's college students : A randomized controlled trial |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2023/12/13 20:29:06 |
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Basic information
Public title
the effectiveness of health education-enhanced decision making program to get HPV vaccination for women's college students : A randomized controlled trial
Acronym
The effectiveness of health education-enhanced decision making program to get HPV vaccination for women's college students : A randomized controlled trial
Scientific Title
The effectiveness of health education-enhanced decision making program to get HPV vaccination for women's college students : A randomized controlled trial
Scientific Title:Acronym
The effectiveness of health education-enhanced decision making program to get HPV vaccination for women's college students : A randomized controlled trial
Region
| Japan |
Condition
Condition
College women's students who are unvaccinated for HPV
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of the decision making program which was developed to promote knowledge about HPV vaccine and beliefs and intention to get HPV vaccines
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HPV vaccine-related beliefs and intention
Key secondary outcomes
HPV vaccine-related knowledge, Decisional conflict
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention program is 45 minutes, consists of a 20-minutes health educations and 25-minutes decision aid program.
Interventions/Control_2
Control group: distribute brochures on HPV vaccines
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
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
1 Females born in 1997 to 2007
Key exclusion criteria
1 Females who are fully vaccinated against HPV
2 Females who are suffering from an acute condition/illness
3 Females who made the decision about HPV vaccinations
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Maki |
| Middle name | |
| Last name | Edazawa |
Organization
Mukogawa Women's University
Division name
Graduate School of Nursing
Zip code
663-8558
Address
6-46 Ikebiraki-cho, Nishinomiya-city, Hyogo
TEL
0798-39-9031
edasawam@mukogawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Edazawa |
Organization
Mukogawa Women's University
Division name
Graduate School of Nursing
Zip code
6638558
Address
6-46 Ikebiraki-cho, Nishinomiya-city, Hyogo
TEL
08031686103
Homepage URL
edasawam@mukogawa-u.ac.jp
Sponsor or person
Institute
Mukogawa Women's University
Institute
Department
Personal name
Maki Edazawa
Funding Source
Organization
Mukogawa Women's University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Mukogawa Women's University
Address
6-46 Ikebiraki-cho, Nishinomiya-city, Hyogo
Tel
0798-45-3575
sienka@mukogawa-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
| 2023 | Year | 12 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 14 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060511
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
