UMIN-CTR Clinical Trial

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
Email	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
Email	yssh0108@yahoo.co.jp

Sponsor
Institute	Oku Medical Clinic
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054537