UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical efficacy of a telemedicine program on lifestyle modification with vital monitoring
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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

Public contact
Name of contact person	Satoki Homma
Organization	School of medicine, Keio university
Division name	Medical Environmental Informatics Science
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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-bin/ctr_e/ctr_view.cgi?recptno=R000025194