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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032643
Receipt No. R000037223
Official scientific title of the study Multicenter Prospective Observational Study for the Evaluation of Online or Tele-medicine of Lifestyle Diseases
Date of disclosure of the study information 2018/05/19
Last modified on 2018/05/19

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Basic information
Official scientific title of the study Multicenter Prospective Observational Study for the Evaluation of Online or Tele-medicine of Lifestyle Diseases
Title of the study (Brief title) Multicenter Prospective Online Medicine Registry
Region
Japan

Condition
Condition Lifestyle Diseases
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of online and tele-medicine for the treatment of lifestyle diseases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Control status of underlying diseases after implementation of online or telemedicine (maximum of 1-year follow-up)
Key secondary outcomes Incidence of adverse event after implementation of online or telemedicine (maximum of 1-year follow-up)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
120 years-old >
Gender Male and Female
Key inclusion criteria Meet both following criteria

1. Patients with lifestyle diseases with whom attending physician think that he/she can provide online or telemedicine using national health-insurance system in Japan.

2. Patients who can understand the study, and can voluntarily get written informed consent.
Key exclusion criteria Meet one of following criteria

1. Severe cardiac, liver, or renal diseases
2. Malignancy under treatment
3. Participants of other clinical studies within 3 months
4. Patients who can not understand the study such as due to psychiatric disorder
5. Other inappropriate patients based on attending physician's discrestion
Target sample size 30

Research contact person
Name of lead principal investigator Masahiko Hara, MD, PhD
Organization Japan Society of Clinical Research
Division name Department of Clinical Investigation
Address Kita-ku Umeda 1-11-1000 Osaka Ekimae 4th Bldg 10F Osaka, 530-0001 Japan
TEL 06-6131-5495
Email hara@japanscr.org

Public contact
Name of contact person Masahiko Hara, MD, PhD
Organization Japan Society of Clinical Research
Division name Department of Clinical Investigation
Address Kita-ku Umeda 1-11-1000 Osaka Ekimae 4th Bldg 10F Osaka, 530-0001 Japan
TEL 06-6131-5495
Homepage URL https://www.japanscr.org
Email hara@japanscr.org

Sponsor
Institute Japan Society of Clinical Research
Institute
Department

Funding Source
Organization MITSUI & 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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 19 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 20 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Multicenter Prospective Observational Study of 3 Institutions


Management information
Registered date
2018 Year 05 Month 19 Day
Last modified on
2018 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037223

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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