UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041946 |
|---|---|
| Receipt number | R000047873 |
| Scientific Title | Examination of the effects of self-monitoring on improving the mental and physical health of people affected by Great East Japan Earthquake |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2021/10/01 13:27:56 |
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Basic information
Public title
Research on promotion of mental and physical health using wristband activity tracker
Acronym
Research on promotion of mental and physical health
Scientific Title
Examination of the effects of self-monitoring on improving the mental and physical health of people affected by Great East Japan Earthquake
Scientific Title:Acronym
Intervention research of self-monitoring
Region
| Japan |
Condition
Condition
Asymptomatic adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to examine the effectiveness of self-monitoring regarding sleep, activity, mental state among the people affected by Great East Japan Earthquake, and to investigate factors involved in maintenance and improvement of mental and physical health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the Pittsburgh Sleep Quality Index (PSQI-J)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants use the wristband activity tracker and record self-monitoring for 3 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Residents of Shichigahama Town
(2) Participating in sleep education conducted in advance
(3) Using a smartphone that can install the app
(4) Japanese is the mother tongue
Key exclusion criteria
(1) Persons with serious physical illness such as infectious disease, cancer, severe diabetes, or gait disturbance
(2) Persons who are currently being treated for mental illness
(3) Persons who have difficulty understanding Japanese
(4) Persons who are judged to be inappropriate by the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Tomita |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
980-8574
Address
1-1 Seiryo-machi, Aobaku, Sendai, Miyagi
TEL
022-717-7262
htomita@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Usukura |
Organization
International Research Institute of Disaster Science, Tohoku University
Division name
Department of Disaster Psychiatry
Zip code
980-8573
Address
2-1 Seiryo-machi, Aobaku, Sendai, Miyagi
TEL
022-717-7897
Homepage URL
usukura@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Medicine
Address
N/A
Tel
N/A
med-kenkyo@grp.tohoku.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
| 2020 | Year | 09 | Month | 30 | 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
6
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
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 12 | 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 | 09 | Month | 30 | Day |
Last modified on
| 2021 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047873
