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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016627
Receipt No. R000019249
Scientific Title The Feasibility Study of Personal Health Record Service: Center of Innovation STREAM in Japan
Date of disclosure of the study information 2015/02/25
Last modified on 2016/02/01

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Basic information
Public title The Feasibility Study of Personal Health Record Service: Center of Innovation STREAM in Japan
Acronym 100-Trial
Scientific Title The Feasibility Study of Personal Health Record Service: Center of Innovation STREAM in Japan
Scientific Title:Acronym 100-Trial
Region
Japan

Condition
Condition Primary prevention for metabolic syndrome
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine how exactly the service would measure the Personal Health Record (PHR), how much it would feedback the users with health information, and how the users would respond.
Basic objectives2 Others
Basic objectives -Others Validation
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sleep duration, self-reported meal size, number of steps and energy expenditure per day recorded in PHR during the study period.
Key secondary outcomes 1.The change of stages in behavior according to the transtheoretical model.
2.Self-reported mean sleep duration per night at one month prior to study.
3.Number of hours and days with accelerometers.
4.Number of times and days the subjects used smartphone app.
5.Service improvements.
6.Number of steps counted by other pedometers.
7.Sleep duration measured by other sleep monitoring devices.

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 Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 The provision of service with wearable sensor and smartphone app.
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
65 years-old >
Gender Male and Female
Key inclusion criteria Healthy individuals who own Android smartphones.
Key exclusion criteria 1.Subjects with sever chronic diseases such as cardiovascular diseases and renal failure.
2.Subjects who install medical equipment in body.
3.Subjects who are pregnant, expect pregnancy, and are breastfeeding.
4.Subjects who are directed to refrain from excessive exercise by medical doctors.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuji, Ichiro
Organization Tohoku University Graduate School of Medicine
Division name Division of Epidemiology, Department of Public Health and Forensic Medicine
Zip code
Address 2-1 Seiryomachi, Aoba-ku, Sendai, Japan
TEL 022-717-8123
Email tsuji1@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sugiyama, Kemmyo
Organization Tohoku University Graduate School of Medicine
Division name Division of Epidemiology, Department of Public Health and Forensic Medicine
Zip code
Address 2-1 Seiryomachi, Aoba-ku, Sendai, Japan
TEL 022-717-8123
Homepage URL
Email ksugiyama@med.tohoku.ac.jp

Sponsor
Institute Division of Epidemiology,Department of Public Health & Forensic Medicine,
Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Research support program "COI STREAM" by Ministry of Education, Culture, Sports, Science and Technology and Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Toshiba Corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東北大学大学院医学系研究科公衆衛生学分野、株式会社東芝ヘルスケア社

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1.	In the first month of the trial, the frequency of the PHR recording was 64.9% in Maintenance stage, 70.0% in Action stage, 73.3% in Preparing stage, 74.1% in Contemplation stage, and 97.6% in Precontemplation stage.  However, in the third month, those frequency fell down to 43.3%, 66.7%, 49.3%, 51.9%, and 37.3%, respectively.
2.	At the end of the trial, 70% level of those who were at first in the Contemplation and Precontemplation stage improved their behavior modification stage. However, among those who were at first in the other stages, the stage improvement percentages were all under 50%.
3.	According to the opinions of the questionnaire respondents, the usage of the PHR service turned out to be low due to our originally developed integration indices for PHR recording.
4.	With regard to the sleep duration time, the correlation coefficient between the time by PHR and that by another accelerometer was -0.32, using the data from 7 nights in 3 subjects. Also, the correlation ratio between the time from PHR and that from the questionnaire was 0.27.
5.	The result using the multiple linear regression analysis showed that, compared to those in the Pre-contemplation stage, those in the Contemplation, Preparation, Action, and Maintenance stage took more daily average steps by 825.9, 658.0, 3011.0, and 2412.4, respectively, at point estimate.  However, neither of them were statistically significant except for Maintenance stage (p=0.02).  Therefore, the effect of our service was not efficient for those whom we intended to change their behavior.
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
2015 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
2015 Year 10 Month 31 Day
Date trial data considered complete
2015 Year 11 Month 30 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 25 Day
Last modified on
2016 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019249

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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