UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047837 |
|---|---|
| Receipt number | R000054537 |
| Scientific Title | Development and clinical outcomes of the Hospital at Home care model by a team of clinics: a retrospective cohort study |
| Date of disclosure of the study information | 2022/05/23 |
| Last modified on | 2022/11/22 10:16:45 |
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Basic information
Public title
Development and clinical outcomes of the Hospital at Home care model by a team of clinics: a retrospective cohort study
Acronym
Development and clinical outcomes of the Hospital at Home care model by a team of clinics: a retrospective cohort study
Scientific Title
Development and clinical outcomes of the Hospital at Home care model by a team of clinics: a retrospective cohort study
Scientific Title:Acronym
Development and clinical outcomes of the Hospital at Home care model by a team of clinics: a retrospective cohort study
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) To describe the characteristics of patients with novel coronavirus infection who were treated at home by a clinic team based on a request for treatment from the Osaka Prefectural Public Health Center, and their clinical outcomes (recovery, emergency visit, hospitalization, and death).
(2) To explore the characteristics associated with the clinical outcomes
Basic objectives2
Others
Basic objectives -Others
descriptive study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A composite outcome of emergency visit, hospitalization, and death at day 30
Key secondary outcomes
emergency visit, hospitalization, death, and medical cost
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with COVID-19 who are regarded as an urgent condition by Osaka Prefectural Public Health Center and received a home-based care or online medical treatment
Key exclusion criteria
Patients who declined to agree to participate in the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Oku |
Organization
Oku Medical Clinic
Division name
n/a
Zip code
5350022
Address
Asahi-ku Shimmori 7-1-4, Osaka, Japan
TEL
06-6969-6937
okunaika06@gmail.com
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Tsujimoto |
Organization
Oku Medical Clinic
Division name
n/a
Zip code
5350022
Address
Asahi-ku Shimmori 7-1-4, Osaka, Japan
TEL
06-6969-6937
Homepage URL
yssh0108@yahoo.co.jp
Sponsor or person
Institute
Oku Medical Clinic
Institute
Department
Personal name
Funding Source
Organization
The Nippon Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Primary Care Association
Address
Nishi-ku Tosabori 1-4-8-703A, Osaka, Japan
Tel
06-6449-7760
jpca@a-youme.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
| 2022 | Year | 05 | Month | 23 | 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
383
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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 28 | Day |
Other
Other related information
This is a retrospective cohort study of patients who were initiated on treatment between January 1, 2022 and March 31, 2022 and followed for up to 30 days.
Management information
Registered date
| 2022 | Year | 05 | Month | 23 | Day |
Last modified on
| 2022 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054537
| 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 |
