UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051454 |
|---|---|
| Receipt number | R000058638 |
| Scientific Title | A study of a Predictive Data Model for maternal mental health depression using a Commercial Wearable Device |
| Date of disclosure of the study information | 2023/06/26 |
| Last modified on | 2024/05/17 12:25:07 |
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Basic information
Public title
A study of a Predictive Data Model for maternal mental health depression using a Commercial Wearable Device
Acronym
A study of a Predictive Data Model for maternal mental health depression using a Commercial Wearable Device
Scientific Title
A study of a Predictive Data Model for maternal mental health depression using a Commercial Wearable Device
Scientific Title:Acronym
A study of a Predictive Data Model for maternal mental health depression using a Commercial Wearable Device
Region
| Japan |
Condition
Condition
Healthy pregnant woman or nursing mother
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Since self-administered questionnaires are currently used to confirm symptoms of perinatal depression, quantification will be attempted in this study by comparing the scores of the self-administered questionnaires, information related to exercise and sleep obtained from a wearable device, and processed information such as heart rate and blood oxygen level.
Basic objectives2
Others
Basic objectives -Others
Since self-administered questionnaires are currently used to confirm symptoms of perinatal depression, quantification will be attempted in this study by comparing the scores of the self-administered questionnaires, information related to exercise and sleep obtained from a wearable device, and processed information such as heart rate and blood oxygen level.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of stress-related values (heart rate variability) with the top 25% and bottom 25% of the Edinburgh Postnatal Depression Scale (EPDS)
Key secondary outcomes
(1) Changes in stress-related values (heart rate variability)
(2) Changes in physical activity
(3) Changes in sleeping hour and sleep efficiency
(4) Edinburgh Postnatal Depression Scale (EPDS)
(5) Correlation coefficient between device data and scores for all information acquired via wearable device
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Subjects with no illness being treated at the time of informed consent
(2) Females aged not less than 18 but less than 60 at the time of informed consent, who are in the second trimester or later of their first pregnancy
(3) Subjects who have a smartphone terminal on which applications can be installed, with no plans to change the model during the research period, and who agree to the terms of use for the wearable device and application used in this research.
(4) Subjects within 4 weeks before the expected delivery date or within 4 weeks after delivery
(5) Subjects who have given written consent to participate in this study and to provide information for this study prior to participating in the study
Key exclusion criteria
(1) Subjects who have difficulty in health management in the perioperative period or due to infection, etc.
(2) Subjects who judged by the principal investigator to have difficulty using a wearable device
(3) Subjects who have any implanted device that can affect heart rate, such as a pacemaker
(4) Subjects who have previously received any treatment for mental disorder such as depression
(5) Subjects with a history of mental disorder such as depression
(6) Subjects taking any drug that may affect heart rate
(7) Subjects who may develop a skin rash due to continuous use of a wearable device
(8) Others who are judged by the principal investigator to be inappropriate for participation in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Soromon |
| Middle name | |
| Last name | Kataoka |
Organization
Hakodate Central General hospital
Division name
obstetrics and gynecology
Zip code
040-8585
Address
33-2, Honcho, Hakodate-shi, Hokkaido
TEL
0138-52-1231
kataokasoromon@outlook.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Ozawa |
Organization
Satt Co.,Ltd
Division name
Clinical Research Promotion Group
Zip code
160-0022
Address
5F ACN Shinjuku Building, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo
TEL
03-5312-5026
Homepage URL
mama-fit@sa-tt.co.jp
Sponsor or person
Institute
Hakodate Central General hospital
Institute
Department
Personal name
Funding Source
Organization
The Dai-ichi Life Insurance Co., Ltd
Tech Doctor Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The Dai-ichi Life Insurance Co., Ltd
Tech Doctor Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakodate Central General hospital
Address
33-2, Honcho, Hakodate-shi, Hokkaido
Tel
0138-52-1231
kataokasoromon@outlook.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 | 06 | Month | 26 | 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
40
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 | 05 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058638
