UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032643 |
|---|---|
| Receipt number | R000037223 |
| Scientific Title | 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 | 2019/11/03 23:50:45 |
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Basic information
Public title
Multicenter Prospective Observational Study for the Evaluation of Online or Tele-medicine of Lifestyle Diseases
Acronym
Multicenter Prospective Online Medicine Registry
Scientific Title
Multicenter Prospective Observational Study for the Evaluation of Online or Tele-medicine of Lifestyle Diseases
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masahiko Hara, MD, PhD |
Organization
Japan Society of Clinical Research
Division name
Department of Clinical Investigation
Zip code
Address
Kita-ku Umeda 1-11-1000 Osaka Ekimae 4th Bldg 10F Osaka, 530-0001 Japan
TEL
06-6131-5495
hara@japanscr.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Hara, MD, PhD |
Organization
Japan Society of Clinical Research
Division name
Department of Clinical Investigation
Zip code
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
hara@japanscr.org
Sponsor or person
Institute
Japan Society of Clinical Research
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2017 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter Prospective Observational Study of 3 Institutions
Management information
Registered date
| 2018 | Year | 05 | Month | 19 | Day |
Last modified on
| 2019 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.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 |
