UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050455 |
|---|---|
| Receipt number | R000050884 |
| Scientific Title | Trials on the learning effect of simulation based education in a home-visit nurse education program (The second phase) |
| Date of disclosure of the study information | 2023/02/28 |
| Last modified on | 2023/02/28 19:00:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Trials on the learning effect of simulation based education in a home-visit nurse education program (The second phase)
Acronym
Trials on the learning effect of simulation based education in a home-visit nurse education program (The second phase)
Scientific Title
Trials on the learning effect of simulation based education in a home-visit nurse education program (The second phase)
Scientific Title:Acronym
Trials on the learning effect of simulation based education in a home-visit nurse education program (The second phase)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The first phase is to conduct a preliminary survey (interview survey) for the purpose of "creating a simulation based education program in home-visit nurse education." The purpose of the second phase is to implement and deliver the "simulation based education program in home-visit nurse education", and to evaluate and verify the validity and effectiveness of the program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The transition in the score of the knowledge test before and after the simulation based education is evaluated at the following timing.
1) Pre and post the first simulation education
2) After 3 months of the 1), Pre and Post the simulation education
3) After 6 months of the 1), Pre and Post the simulation education
4) After 9 months of the 1), Pre and Post the simulation education
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver | Other |
Interventions/Control_1
90 minutes simulation based education program will be conducted at the facility to which the research participants belong.
It will be implemented 4 times every 3 months from the first implementation.
The research participants simulate the physical assessment and necessary care for about 10 minutes for the simulator set based on the each scenario.
Before and after the simulation, e-learning will be conducted to confirm the knowledge.
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
| 21 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Newer home-visit nurses who belong to home-based nursing center facilities and home-visit nurses who wish to receive training in the first phase(preliminary survey).
Key exclusion criteria
Nursing managers at research cooperation facilities are excluded.
Excludes those who are judged by the nursing manager to be excluded due to any reasons.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hirakawa |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Science
Zip code
116-8551
Address
7-2-10 Higashiohisa, Arakawa-Ku, Tokyo
TEL
03-3819-1211
hirakawa-yoshihiro@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hirakawa |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Science
Zip code
116-8551
Address
7-2-10 Higashiohisa, Arakawa-Ku, Tokyo
TEL
03-3819-1211
Homepage URL
hirakawa-yoshihiro@ed.tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan 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
Tokyo Metropolitan University
Address
7-2-10 Higashiohisa, Arakawa-Ku, Tokyo
Tel
03-3819-1211
rinri-hs@tmu.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 28 | 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
33
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 | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 28 | Day |
Last modified on
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050884
