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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038207
Receipt No. R000043548
Scientific Title Investigate the benefits of telemedicine home support systems: A pilot randomized controlled trial
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/04

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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 Jyunya
Middle name
Last name Kinkawa
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
Homepage URL
Email jkinkawa@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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 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
2019 Year 10 Month 04 Day


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

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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