UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016627 |
|---|---|
| Receipt number | 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 11:27:50 |
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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
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
ksugiyama@med.tohoku.ac.jp
Sponsor or person
Institute
Division of Epidemiology,Department of Public Health & Forensic Medicine,
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019249
