UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030899 |
|---|---|
| Receipt number | R000035284 |
| Scientific Title | Utility of time-based monitoring using home medical devices and IoT technology in elderly and chronically ill patients |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/02/21 21:03:40 |
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Basic information
Public title
Utility of time-based monitoring using home medical devices and IoT technology in elderly and chronically ill patients
Acronym
Establishment of the latest system using Telemedicine and IoT
Scientific Title
Utility of time-based monitoring using home medical devices and IoT technology in elderly and chronically ill patients
Scientific Title:Acronym
Establishment of the latest system using Telemedicine and IoT
Region
| Japan |
Condition
Condition
Terminal chronic disease
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Pneumology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exacerbation prophylaxis by at-home monitoring of terminal chronic diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exacerbation frequency (emergency visit, emergency hospitalization)
Patient satisfaction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Home monitoring by medical equipment
Interventions/Control_2
Home monitoring by placebo
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who need medical care at outpatient / home
Consent
Key exclusion criteria
Non agreement
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | KOBAYASHI |
| Middle name | |
| Last name | Takehito |
Organization
Saitama Medical University
Division name
Department of General internal Medicine
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
kobatake@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takehito |
| Middle name | |
| Last name | KOBAYASHI |
Organization
Saitama Medical University
Division name
Department of General internal Medicine
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
Homepage URL
kobatake@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
Iruma, Moroyama, Morohongo 38Department of Respiratory Medicine
Tel
0492761354
hirb@saitama-med.ac.jp
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 | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 19 | Day |
Last modified on
| 2020 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035284
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
