UMIN-CTR Clinical Trial

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
Email	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
Email	kobatake@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035284