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

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 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


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

Value
https://center6.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