UMIN-CTR Clinical Trial

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
Email	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
Email	usukura@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047873