UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021848
Receipt number 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 00:45:02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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

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 or person

Institute

School of Medicine, Keio University

Institute

Department

Personal name



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

Value
https://center6.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