UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052223 |
|---|---|
| Receipt number | R000059590 |
| Scientific Title | Verification of the effectiveness of information dissemination on HPV vaccination by insurance pharmacies targeting patients visiting pharmacies |
| Date of disclosure of the study information | 2023/09/25 |
| Last modified on | 2024/07/25 22:04:37 |
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Basic information
Public title
Ongoing questionnaire survey of patients visiting pharmacies regarding vaccination
Acronym
Ongoing questionnaire survey of patients visiting pharmacies regarding vaccination
Scientific Title
Verification of the effectiveness of information dissemination on HPV vaccination by insurance pharmacies targeting patients visiting pharmacies
Scientific Title:Acronym
Verification of the effectiveness of information dissemination on HPV vaccination by insurance pharmacies targeting patients visiting pharmacies
Region
| Japan |
Condition
Condition
For healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether disseminating information about cervical cancer and the HPV vaccine to patients visiting pharmacies will increase their willingness to recommend the HPV vaccine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients visiting pharmacies who were positive about HPV vaccination 3 months after the poster was posted
Key secondary outcomes
(1) Percentage of patients positive about HPV vaccination in relation to the number of visits to the pharmacy
(2) Amount of change in knowledge about HPV vaccine between before and after the poster was posted
(3) Evaluation of the relationship between the presence of active informational support by pharmacies displaying posters and impressions of HPV vaccination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention group: Receiving Information on Cervical Cancer and HPV Vaccine at a Pharmacy (Poster Display and Leaflet Distribution).
Interventions/Control_2
Control group: Not receiving information on cervical cancer and HPV vaccine at a pharmacy (no poster display, no leaflet distribution),
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who received sufficient explanation regarding the purpose and contents of this research, those who could consent, and those who fully understood the goal of this research and voluntarily agreed to participate.
Key exclusion criteria
(1) Those who declined to participate in the research on their own will
(2) Individuals who are deemed ineligible by the research director
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
n-wakui@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
Homepage URL
n-wakui@hoshi.ac.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Funding Source
Organization
Hoshi 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
Research Ethics Committee of Hoshi university
Address
Ebara, Shinagawa-ku, Tokyo
Tel
03-3786-1011
somu@hoshi.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 | 09 | 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
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
| 2023 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2024 | 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 | 09 | Month | 15 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059590
