UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055275 |
|---|---|
| Receipt number | R000063161 |
| Scientific Title | Effectiveness of an E-Learning Educational Program for Lymphedema Ultrasound Assessment in Healthcare Professionals: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/08/19 |
| Last modified on | 2024/08/19 15:34:17 |
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Basic information
Public title
Effectiveness of an E-Learning Educational Program for Lymphedema Ultrasound Assessment in Healthcare Professionals: A Randomized Controlled Trial
Acronym
Effectiveness of Educational Methods for Ultrasound Observation of Affected Limbs in Lymphedema Patients
Scientific Title
Effectiveness of an E-Learning Educational Program for Lymphedema Ultrasound Assessment in Healthcare Professionals: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of an E-Learning Educational Program for Lymphedema Ultrasound Assessment in Healthcare Professionals: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Lymphedema
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effectiveness of an educational program on lymphedema ultrasound assessment for healthcare professionals.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether or not the ultrasound observation of lymphedema patients was conducted within two weeks of course completion as a measure of behavior change.
Key secondary outcomes
The number of ultrasound observations conducted on lymphedema patients within two weeks of course completion.
Whether or not there was communication among healthcare professionals regarding lymphedema ultrasound assessment within two weeks of course completion.
Whether or not arrangements (including consideration) were made for ultrasound assessment of lymphedema within two weeks of course completion.
Whether or not lymphedema assessment was conducted within two weeks of course completion.
Whether or not lymphedema care was provided within two weeks of course completion.
The level of confidence in managing lymphedema within two weeks of course completion.
Understanding of the pathophysiology of lymphedema before and after the course.
Understanding of lymphedema assessment before and after the course.
Understanding of lymphedema ultrasound assessment immediately after the course.
Level of confidence in managing lymphedema immediately after the course.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention involves providing education on lymphedema ultrasound assessment. In addition to traditional assessment methods, the course covers the significance of lymphedema ultrasound assessment, the principles and use of ultrasound, and the methods for performing lymphedema ultrasound assessment.
All lectures are delivered via e-learning, and participants can access them through a designated URL without any restrictions on time, location, or the number of times they can view the content.
Interventions/Control_2
The control group will receive education on traditional lymphedema assessment. All lectures are delivered via e-learning, and participants can access them through a designated URL without any restrictions on time, location, or the number of times they can view the content.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthcare professionals
Key exclusion criteria
Individuals who do not hold a national medical qualification.
Individuals who are unable or unwilling to access, complete, and submit the online survey form, or to participate in the e-learning program.
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Misako |
| Middle name | |
| Last name | Dai |
Organization
Ishikawa Prefectural Nursing University
Division name
Faculty of Nursing
Zip code
929-1210
Address
1-1, Gakuendai, Kahoku, Ishiskawa, Japan
TEL
0762818334
misakodai0909@gmail.com
Public contact
Name of contact person
| 1st name | Misako |
| Middle name | |
| Last name | Dai |
Organization
Ishikawa Prefectural Nursing University
Division name
Faculty of Nursing
Zip code
929-1210
Address
1-1, Gakuendai, Kahoku, Ishikawa
TEL
0762818334
Homepage URL
misakodai0909@gmail.com
Sponsor or person
Institute
Ishikawa Prefectural Nursing University
Institute
Department
Personal name
Misako Dai
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ishikawa Prefectural Nursing University Ethics Committee
Address
1-1, Gakuendai, Kahoku, Ishikawa
Tel
076-281-8300
office@ishikawa-nu.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
| 2024 | Year | 08 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 19 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063161
