UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050095 |
|---|---|
| Receipt number | R000057066 |
| Scientific Title | Relationship between menopausal women's health literacy, work performance, and QOL |
| Date of disclosure of the study information | 2023/01/21 |
| Last modified on | 2025/02/15 16:03:42 |
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Basic information
Public title
Relationship between menopausal women's health literacy, work performance, and QOL
Acronym
Relationship between menopausal women's health literacy, work performance, and QOL
Scientific Title
Relationship between menopausal women's health literacy, work performance, and QOL
Scientific Title:Acronym
Relationship between menopausal women's health literacy, work performance, and QOL
Region
| Japan |
Condition
Condition
menopausal symptoms
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between women's health literacy, work performance and QOL of perimenopausal working women.
Basic objectives2
Others
Basic objectives -Others
The intervention group will be compared with the control group to clarify whether the health literacy score increases.
The intervention group will be sent weekly messages about health issues specific to menopausal women for 8 weeks.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
health literacy, health, work performance, QOL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
| Behavior,custom |
Interventions/Control_1
The intervention group will be sent weekly messages about health issues specific to menopausal women for 8 weeks.
Interventions/Control_2
No message is sent to the control group.
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
| 40 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged 40-55 working in Japan
Key exclusion criteria
People who cannot read or write Japanese
People with a history of cancer or a history of current illness
After hysterectomy/oophorectomy, chromosomal abnormalities that cause premature menopause (Turner syndrome, fragile X syndrome, etc.), autoimmune diseases (thyroiditis, myasthenia gravis, vitiligo, etc.), diabetes, Addison's disease, parathyroid function Women with depression and other metabolic disorders
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Emiko |
| Middle name | |
| Last name | Nishioka |
Organization
Juntendo University
Division name
Faculty of Health Science and Nursing
Zip code
4118787
Address
3-7-33, Oomiya-cho, Mishima, Shizuoka
TEL
0559416792
enishio@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Emiko |
| Middle name | |
| Last name | Nishioka |
Organization
Juntendo University
Division name
Faculty of Health Science and Nursing
Zip code
4118787
Address
3-7-33, Oomiya-cho, Mishima, Shizuoka
TEL
0559746792
Homepage URL
enishio@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Emiko Nishioka
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Defense Medical College
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Faculty of Health Science and Nursing IRB
Address
3-7-33, Oomiya-cho, Mishima, Shizuoka
Tel
0559913111
enishio@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
4-014
Org. issuing International ID_1
4-18
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 | 01 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 21 | Day |
Last modified on
| 2025 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057066
