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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021848
Receipt No. R000025194
Scientific Title Clinical efficacy of a telemedicine program on lifestyle modification with vital monitoring
Date of disclosure of the study information 2016/04/10
Last modified on 2016/04/10

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Basic information
Public title Clinical efficacy of a telemedicine program on lifestyle modification with vital monitoring
Acronym Effects of telemedicine with vital monitoring on lifestyle modification (TVM study)
Scientific Title Clinical efficacy of a telemedicine program on lifestyle modification with vital monitoring
Scientific Title:Acronym Effects of telemedicine with vital monitoring on lifestyle modification (TVM study)
Region
Japan

Condition
Condition Lifestyle diseases (incl. hypertension, dyslipidemia and diabetes mellitus)
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To change lifestyle behaviors for the treatment of hypertension, diabetes, dyslipidemia and obesity, a telemonitoring system (i-TECHO) consisting of an automated sphygmomanometer, a body weighing scale and a pedometer with a specific home-gateway device connected to every monitor in the system by USB, which transmitted self-monitoring data to a central server via the cellular-phone network, is examined.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Body weight reduction or decrease of blood pressure or increase of steps
2. Lifestyle modification (improved lifestyle behavior stages)
Key secondary outcomes Operation performance of the system

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Self-monitoring of a pedometer, an automated sphygmomanometer, and a body weighing scale and a feed-back of the results of monitoring for 3 month-period
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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients with lifestyle diseases including hypertension or dyslipidemia or diabetes mellitus
Key exclusion criteria Patients under risks induced by promotion of exercise
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Satoki Homma
Organization School of medicine, Keio university
Division name Medical Environmental Informatics Science
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL +81-3-3350-4227
Email s-homma@sc.itc.keio.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Satoki Homma
Organization School of medicine, Keio university
Division name Medical Environmental Informatics Science
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL +81-3-3350-4227
Homepage URL
Email s-homma@sc.itc.keio.ac.jp

Sponsor
Institute School of Medicine, Keio University
Institute
Department

Funding Source
Organization OMRON HEALTHCARE Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 2009-227
Org. issuing International ID_1 School of Medicine, Keio University,
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 10 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
One hundred and two patients with lifestyle diseases (averaged age of 51.5, 84 males and 18 females) were paticipated. All the average measures including blood pressure, body weight and daily steps were significantly improved, especially in the subjects with initially poor lifestyle status. The actual measurements as a proportion of the total number due were 55-76% for each sensor. These rates decreased significantly in the third month. Although only 5-12% of the subjects complained of poor operability of self-measurement, a greater proportion (32.5%) found difficulty in the procedures of data transmission. Elderly people showed greater willingness to pay for a potential commercial service of health promotion using i-TECHO.
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
2010 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2010 Year 07 Month 05 Day
Date of closure to data entry
2010 Year 09 Month 01 Day
Date trial data considered complete
2010 Year 09 Month 01 Day
Date analysis concluded
2011 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 10 Day
Last modified on
2016 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025194

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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