UMIN-CTR Clinical Trial

Basic information
Public title	Investigate the benefits of telemedicine home support systems: A pilot randomized controlled trial
Acronym	I'm home study
Scientific Title	Investigate the benefits of telemedicine home support systems: A pilot randomized controlled trial
Scientific Title:Acronym	I'm home study
Region	Japan

Condition
Condition	Frailty
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, social network service (Medical Care Station: https://www.medical-care.net/html/) for high-risk patients undergoing emergency revisit coordinating with home medical care. Randomized comparison of patient group (SNS group) that provides home support using (SNS) and patient group (non-SNS group) that provides home support without using SNS. Consider the effectiveness of.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Emergency hospitalization (rate) 30 days after intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	The patient will be discharged from the Department of Palliative Medicine, Saitama Medical University Hospital, and patients who will be transferred to home medical care will be randomized, and will be followed up in a patient group managed using Medical Care Station and a normal management group. The intervention period will be 90 days from the time of patient registration.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients urgently transported to an emergency center 2) Patients who are over 20 years old when obtaining consent 3) Patients who accepted the introduction of home medical care 4) Patients whose prognosis is predicted to be more than 3 months 5) Patients whose written consent has been obtained from the patient
Key exclusion criteria	1) Patients judged by the attending physician as inappropriate for this study
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Iwase
Organization	Saitama Medical University Hospital
Division name	Department of Emergency and Palliative Medicine
Zip code	3500495
Address	38 Moro Hongo, Moroyama-cho, Iruma-gun, Saitama
TEL	049-276-1705
Email	siwase@saitama-med.ac.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Sato
Organization	Saitama Medical University Hospital
Division name	Palliative Medicine
Zip code	3500495
Address	38 Moro Hongo, Moroyama-cho, Iruma-gun, Saitama
TEL	049-276-1705
Homepage URL
Email	satot@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University Hospital
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama Medical University Hospital IRB Committee
Address	38 Moro Hongo, Moroyama-cho, Iruma-gun, Saitama
Tel	049-276-1354
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	2019 Year 11 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	Enrolling by invitation
Date of protocol fixation	2019 Year 10 Month 05 Day
Date of IRB	2019 Year 11 Month 11 Day
Anticipated trial start date	2020 Year 02 Month 19 Day
Last follow-up date	2021 Year 01 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 04 Day
Last modified on	2020 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043548