UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042725 |
|---|---|
| Receipt number | R000048767 |
| Scientific Title | Randomized parallel-group trial |
| Date of disclosure of the study information | 2020/12/11 |
| Last modified on | 2020/12/14 09:33:19 |
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Basic information
Public title
Evaluation of the web materials for learning removal personal protective equipment skills for highly infectious diseases
Acronym
Evaluation of the web materials for learning removal personal protective equipment skills for highly infectious diseases
Scientific Title
Randomized parallel-group trial
Scientific Title:Acronym
Randomized parallel-group trial
Region
| Japan |
Condition
Condition
Nurses who are involved in the care of patients with highly infectious diseases and who have a high need to learn skills for putting on and removal personal protective equipment.
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a web-based teaching material for learning personal protective equipment removal skills for highly infectious diseases after providing it for three months with knowledge and skills.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knowledge after a web-based teaching material had been available for three months.
Key secondary outcomes
Skills after a web-based teaching material had been available for three months.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Intervention/Using a web-based teaching material for three months
Interventions/Control_2
Control/No instruction is provided
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Have a communication device (PC, smartphone, tablet terminal, etc.) that can use the Internet, or there is an environment where you can use the Internet.
Key exclusion criteria
1) There is a problem with changing clothes.
2) There is skin injury.
3) Pregnant
4) There is an abnormality in the patch test of the fluorescent marker used in this investigation.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University
Division name
Graduate School of Health Care and Nursing
Zip code
279-0023
Address
2-5-1 Takasu, Urayasu-shi, Chiba-ken
TEL
0473553111
m3116013@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University
Division name
Graduate School of Health Care and Nursing
Zip code
279-0023
Address
2-5-1 Takasu, Urayasu-shi, Chiba-ken
TEL
0473553111
Homepage URL
m3116013@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-5-1 Takasu, Urayasu-shi, Chiba-ken
Tel
0473553111
m3116013@juntendo.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
自衛隊熊本病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 11 | 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
36
Results
After the intervention, knowledge test scores were significantly better in the intervention group than in the control group (p = .013), while the number of personal protective equipment removal procedure deviations was significantly lower in the intervention group than in the control group (p = .001).
In contrast, the number of self-contamination sites (p = .128) and number of contaminated participants (p = .242) did not significantly differ between groups.
Results date posted
| 2020 | Year | 12 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All of the participants were female.
Intervention group / mean age: 44.1 (SD3.7) , mean clinical experience: 21.4 (SD4.5) , experience of putting on and removal personal protective equipment: median 1.5 times
Control group / mean age 43.2 (SD4.7) years, mean clinical experience: 20.8 (SD5.3) years, experience of putting on and removal personal protective equipment: median 2.0 times
Participant flow
Consent to participate in this study was obtained from 36 participants.
We included 35 participants, excluding one who was not included in the selection criteria.
17 participants in the intervention group and 18 participants in the control group were randomly allocated. One of the intervention group was not intervened due to a transfer.
Finally, the data obtained from 16 intervention groups and 18 control groups were analyzed.
Adverse events
none
Outcome measures
1)Knowledge test score
2)Number of personal protective equipment removal procedure deviations
3)Number of self-contamination sites
4)Number of contaminated participants
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 12 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 22 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 11 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048767
