UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000981 |
|---|---|
| Receipt number | R000001178 |
| Scientific Title | Daily use of masks for preventing common cold |
| Date of disclosure of the study information | 2008/01/14 |
| Last modified on | 2010/07/30 16:06:07 |
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Basic information
Public title
Daily use of masks for preventing common cold
Acronym
Mask Study
Scientific Title
Daily use of masks for preventing common cold
Scientific Title:Acronym
Mask Study
Region
| Japan |
Condition
Condition
common cold
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The specific aim of the present study is to determine if wearing a large respiratory droplet mask decreases the risk of acquiring an upper respiratory infection. The null hypothesis is that there is no difference in number of URIs acquired between groups, and that duration and severity of illness is the same. The rationale for doing this study is that if the hypothesis is true, then the use of masks may be reduced or eliminated for this type of purpose. This will save money and lessen environmental impact, as well as allow healthcare workers to interact with each other and with their patients with the full facial expression and other nonverbal communication at their disposal.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Prevalence rate of common cold judged by Jackson Criteria
Key secondary outcomes
1.Outpatient clinical visit
2.Duration of hospitalization
3.Laboratory tests,radiological tests, and drugs
4.Use of over-the-counter
5.Use of CAM treatments
6.Complication of treatments
7.Productivity loss and time lost from work
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
daily wearing surgical masks
Interventions/Control_2
no mask wearing
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Works in an outpatient clinic of a hospital, older than 18 years old.
Key exclusion criteria
Chronic respiratory illness, immunodeficiency state (including medication-induced), chronic allergic or vasomotor rhinitis, taking antibiotics, current smoker as defined by having smoked a tobacco product within 1 month of recruitment, unable or unwilling to follow study protocol.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Joshua Jacobs |
Organization
St. Luke's Life Science Institute
Division name
Clinical Practice and Evaluation Center
Zip code
Address
10-1 Akashicho Chuo Tokyo
TEL
03-5550-2426
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Ohde |
Organization
St. Luke's Life Science Institute
Division name
Clinical Practice and Evaluation Center
Zip code
Address
10-1 Akashicho Chuo Tokyo
TEL
03-5550-2426
Homepage URL
saohde@luke.or.jp
Sponsor or person
Institute
St. Luke's Life Science Institute
Institute
Department
Personal name
Funding Source
Organization
St. Luke's Life Science Institute intermural research project
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
St. Luke's International Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2007 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 11 | Day |
Last modified on
| 2010 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001178
