UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029774 |
|---|---|
| Receipt number | R000034022 |
| Scientific Title | Effectiveness of pediatric teleconsultation to reduce postpartum stress in mothers and to improve skin conditions in infants: a randomized controlled trial. |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2022/02/20 19:04:03 |
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Basic information
Public title
Effectiveness of pediatric teleconsultation to reduce postpartum stress in mothers and to improve skin conditions in infants: a randomized controlled trial.
Acronym
Sakae Infants and Mothers with Pediatric teLEconsultation (SIMPLE) study
Scientific Title
Effectiveness of pediatric teleconsultation to reduce postpartum stress in mothers and to improve skin conditions in infants: a randomized controlled trial.
Scientific Title:Acronym
Sakae Infants and Mothers with Pediatric teLEconsultation (SIMPLE) study
Region
| Japan |
Condition
Condition
Parenting stress
Atopic dermatitis
Classification by specialty
| Pediatrics | Dermatology | Psychiatry |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness of pediatric teleconsultation for reducing postpartum stress in mothers and preventing atopic dermatitis in infants
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
(1)Parenting Stress Index Short Form (PSI-SF) and General Health Questionnaire-12 (GHQ-12) of mothers at the 4-month checkup
(2)Prevalence of atopic dermatitis of infants at the 4-month checkup
Key secondary outcomes
･Breastfeeding rates at the 4-month checkup
･Developmental Quotient (DQ) of infants at the 4-month checkup
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Interventions: Participants have an option to use the pediatric teleconsultation service from the registration to 4 months of age
Interventions/Control_2
Control: no interventions
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
| 4 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Pairs of mother and infant who will submit the birth card to Yokohama City Sakae Ward Office from November 1, 2017 to May 31, 2018
Key exclusion criteria
1. Unwillingness or inability to comply with the study requirements and procedures
2. Determined by study staff that either the mother or the infant may be adversely affected by participating in this trial
3. Mothers' inability to understand Japanese (communication through interpreter could be exceptional)
4. Infants born before 37 weeks of gestation
5. Infants born after 42 weeks of gestation
6. Twins or multiples
7. Infants needed neonatal intensive care
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Tomohisa |
Organization
National Center for Child Health and Development
Division name
Department of Health Policy
Zip code
1578535
Address
2-10-1 Okura, Setagaya-ku, 157-8535, Tokyo, Japan
TEL
03-3416-0181
ando-tm@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Ando |
Organization
National Center for Child Health and Development
Division name
Department of Health Policy
Zip code
1578535
Address
2-10-1 Okura, Setagaya-ku, 157-8535, Tokyo, Japan
TEL
03-3416-0181
Homepage URL
simple-study@ncchd.go.jp
Sponsor or person
Institute
Department of Health Policy, National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yokohama City Sakae Ward Office
Name of secondary funder(s)
Kids Public Inc.
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya-ku, 157-8535, Tokyo, Japan
Tel
03-3416-0181
hagino-k@ncchd.go.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
横浜市栄区（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://pediatrics.jmir.org/2022/1/e27615
Number of participants that the trial has enrolled
278
Results
The prevalence of atopic dermatitis in infants was significantly lower in the intervention group than in the control group during the 4-month checkup (20% vs 33%, P=.03; relative risk ratio, 0.614 [95% CI 0.406-0.927]). No significant differences were observed in the Parenting Stress Index-Short Form and General Health Questionnaire-12 scores between the 2 groups.
Results date posted
| 2022 | Year | 02 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We detected no significant differences in their characteristics.
Participant flow
In total, 318 pairs of infants and mothers in the Yokohama City Sakae Ward were recruited when they submitted birth cards to the ward, received the explanation about the trial, and provided informed consent on the website for this trial. Eligible pairs of infants and mothers were randomly assigned to the intervention group (n=140) or the control group (n=138). Participants in the intervention and control groups received routine postnatal care from local government services. In addition, participants in the intervention group had the option to combine routine pediatric services with teleconsultation and email newsletters without charge from the date of registration until the infant turned 4 months.
Adverse events
There were no adverse events in this trial.
Outcome measures
The primary outcomes were the prevalence of atopic dermatitis in infants, parenting stress, and mothers' mental health status at the 4-month checkup.
Secondary outcomes were breastfeeding rates and the developmental quotient of infants at the 4-month checkup.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 31 | Day |
Last modified on
| 2022 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034022
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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