UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034644 |
|---|---|
| Receipt number | R000039497 |
| Scientific Title | Examination of effectiveness of counseling in menopausal outpatient |
| Date of disclosure of the study information | 2018/10/29 |
| Last modified on | 2020/10/26 11:30:29 |
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Basic information
Public title
Examination of effectiveness of counseling in menopausal outpatient
Acronym
counseling of menopausal outpatient
Scientific Title
Examination of effectiveness of counseling in menopausal outpatient
Scientific Title:Acronym
counseling of menopausal outpatient
Region
| Japan |
Condition
Condition
climacteric disorder
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of counseling that is conducted for menopausal patients at menopause outpatients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the center for epidemiologic studies depression scale
Key secondary outcomes
Subjective well-being inventry
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
counseling
Interventions/Control_2
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
receive counseling
Key exclusion criteria
severe mental symptom
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YUKIKO |
| Middle name | |
| Last name | IIOKA |
Organization
saitama prefectural university
Division name
Graduate school of Health and Social Services
Zip code
343-8540
Address
820 san-nomiya, koshigaya-shi,saitama, 343-8540, Japan
TEL
048-973-4168
iioka-yukiko@spu.ac.jp
Public contact
Name of contact person
| 1st name | YUKIKO |
| Middle name | |
| Last name | IIOKA |
Organization
Saitama Prefectural University
Division name
Graduate school of Health and Social Services
Zip code
3438540
Address
820 san-nomiya, koshigaya-shi, saitama, 343-8540, Japan
TEL
048-973-4168
Homepage URL
iioka-yukiko@spu.ac.jp
Sponsor or person
Institute
saitama prefectural university
Institute
Department
Personal name
Funding Source
Organization
saitama prefectural 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
Saitama Prefectural University
Address
820 San-nomiya, Koshigaya-shi, Saitama, 343-8540, JAPAN
Tel
048-971-0500
iioka-yukiko@spu.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
| 2018 | Year | 10 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 10 | Month | 25 | Day |
Last modified on
| 2020 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039497
