UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038207 |
|---|---|
| Receipt number | 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 | 2020/05/25 12:58:23 |
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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
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
satot@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043548
| 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 |
