UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057451 |
|---|---|
| Receipt number | R000065216 |
| Scientific Title | Effectiveness of Visitor Restrictions in Preventing COVID-19 Cluster Outbreaks |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/30 22:22:22 |
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Basic information
Public title
Effectiveness of Visitor Restrictions in Preventing COVID-19 Cluster Outbreaks
Acronym
EVR for COVID-19
Scientific Title
Effectiveness of Visitor Restrictions in Preventing COVID-19 Cluster Outbreaks
Scientific Title:Acronym
EVR for COVID-19
Region
| Japan |
Condition
Condition
Cluster outbreaks of COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the restriction of visitations contributed to the suppression of cluster outbreaks of COVID-19.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of COVID-19 Cluster Outbreaks Among Hospitalized Patients/Facility Residents According to Visitation Restriction Levels (Time Restrictions, Number Restrictions, Meal Restrictions)
Key secondary outcomes
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
JADECOM-affiliated geriatric health services facility, rehabilitation ward, comprehensive community care ward, convalescent ward, and nursing care medical institution.
Key exclusion criteria
N/A
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Mochizuki |
Organization
JADECOM
Division name
Institute of community medicine
Zip code
102-0093
Address
15th Floor, Prefectural Assembly Building, 2-6-3 Hirakawacho, Chiyoda-ku, Tokyo, Japan
TEL
+81-3-5212-9152
takahirom@jadecom.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Mochizuki |
Organization
JADECOM
Division name
Institute of community medicine
Zip code
102-0093
Address
15th Floor, Prefectural Assembly Building, 2-6-3 Hirakawacho, Chiyoda-ku, Tokyo, Japan
TEL
+81-3-5212-9152
Homepage URL
takahirom@jadecom.jp
Sponsor or person
Institute
JADECOM
Institute
Department
Personal name
Funding Source
Organization
JADECOM
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JADECOM
Address
15th Floor, Prefectural Assembly Building, 2-6-3 Hirakawacho, Chiyoda-ku, Tokyo, Japan
Tel
+81-3-5212-9152
masatosh@jadecom.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
| 2025 | Year | 04 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In non-acute care wards of JADECOM-affiliated hospitals and in each ward of geriatric health service facilities, we will investigate the association between the levels of visitation time restrictions, visitor number restrictions, and meal restrictions and the occurrence of COVID-19 cluster outbreaks among hospitalized patients/residents using survival analysis (Cox regression).
Management information
Registered date
| 2025 | Year | 03 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065216
