UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050910 |
|---|---|
| Receipt number | R000057582 |
| Scientific Title | Validation of the effectiveness of a web-based learning program for belief conflict held by healthcare workers |
| Date of disclosure of the study information | 2023/04/24 |
| Last modified on | 2023/04/24 10:40:22 |
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Basic information
Public title
Evaluation of the effectiveness of a learning program for resolving interpersonal problems faced by healthcare workers
Acronym
Evaluation of the effectiveness of a learning program
Scientific Title
Validation of the effectiveness of a web-based learning program for belief conflict held by healthcare workers
Scientific Title:Acronym
Validation of the effectiveness of a web-based learning program
Region
| Japan |
Condition
Condition
High belief conflict state
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate and report on the effectiveness of a web-based learning program on belief conflicts and mental health problems among healthcare professionals, using objective measures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Assessment of Belief Conflict for Factor and Response
2. Classification and Assessment of Occupational Dysfunction
3. Depression, Anxiety, Stress Scale21
4. time in bed
5. total sleep time
6. wake after sleep onset
7. Heart rate variability
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention will be conducted using a web-based learning program. The intervention period is 60 days. During the intervention period, subjects will participate in the web-based learning program once a week, and each session will take approximately 30 minutes.
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
| 22 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthcare workers with a total score of 58 or more on the ABCR-14 (Assessment of Belief Conflict in Relationship-14).
Key exclusion criteria
Persons who are prescribed medication by a doctor to maintain mental function. Persons suffering from cardiac disease.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Oogishi |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Occupational Therapy, Faculty of Rehabilitation
Zip code
701-0193
Address
Matushima 288, Kurashiki City, Okayama Prefecture, Japan
TEL
+81-86-462-1111
t.oogishi@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | Oogishi |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Occupational Therapy, Faculty of Rehabilitation
Zip code
701-0193
Address
Matushima 288, Kurashiki City, Okayama Prefecture, Japan
TEL
+81-86-462-1111
Homepage URL
t.oogishi@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Kawasaki University of Medical Welfare
Address
Matushima 288, Kurashiki City, Okayama Prefecture, Japan
Tel
+81-86-462-1111
t.oogishi@mw.kawasaki-m.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 | 04 | Month | 24 | 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
| 2022 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2023 | Year | 04 | Month | 24 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057582
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
