UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040594 |
|---|---|
| Receipt number | R000045667 |
| Scientific Title | the use of teleconsultation in pediatrics, obstetrics and gynecology in rural areas |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/05/30 19:54:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
the use of teleconsultation in pediatrics, obstetrics and gynecology in rural areas
Acronym
the use of teleconsultation in pediatrics, obstetrics and gynecology in rural areas
Scientific Title
the use of teleconsultation in pediatrics, obstetrics and gynecology in rural areas
Scientific Title:Acronym
the use of teleconsultation in pediatrics, obstetrics and gynecology in rural areas
Region
| Japan |
Condition
Condition
pediatrics, obstetrics and gynecology in general
Classification by specialty
| Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of teleconsultation in pediatrics, obstetrics and gynecology in rural areas in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
# proportion of participants who have access to pediatricians, obstetricians, gynecologists, and midwives to consult for
Key secondary outcomes
# frequency of hesitation to consult for specialists in pediatrics, obstetrics and gynecology
# frequency of non-urgent healthcare visit
# maternal anxiety in child raising
# maternal anxiety for child sickness
# number of people who consult for about child raising
# proportion of EPDS positive participants
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
utilization of teleconsultation in pediatrics, obstetrics and gynecology for 6-9 months
Interventions/Control_2
nothing
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
# participants who have LINE application
# fluent in Japanese
Key exclusion criteria
# participants whose child has chronic disease
Target sample size
186
Research contact person
Name of lead principal investigator
| 1st name | Harada |
| Middle name | |
| Last name | Masanori |
Organization
Yamaguchi Prefectual Grand Medical Center
Division name
Support Center for Rural Medicine
Zip code
7478511
Address
10077 Osaki, Hofu, Yamaguchi 747-8511 Japan
TEL
0835-22-4411
masa.harada@mac.com
Public contact
Name of contact person
| 1st name | Harada |
| Middle name | |
| Last name | Masanori |
Organization
Yamaguchi Prefectual Grand Medical Center
Division name
Support Center for Rural Medicine
Zip code
7478511
Address
10077 Osaki, Hofu, Yamaguchi 747-8511 Japan
TEL
0835-22-4411
Homepage URL
masa.harada@mac.com
Sponsor or person
Institute
Yamaguchi Prefectual Grand Medical Center Support Center for Rural Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Yamaguchi Prefectual Grand Medical Center
Address
10077 Osaki, Hofu, Yamaguchi 747-8511 Japan
Tel
0835-22-4411
masa.harada@mac.com
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
| 2020 | Year | 06 | Month | 01 | 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
| 2020 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | 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
| 2020 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045667
