UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056923 |
|---|---|
| Receipt number | R000065052 |
| Scientific Title | Research project on confirmation of the improvement of resilience, psychological safety and medical safety using electronic information system |
| Date of disclosure of the study information | 2025/02/15 |
| Last modified on | 2025/02/03 20:48:47 |
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Basic information
Public title
Research project on confirmation of the improvement of resilience, psychological safety and medical safety using electronic information system
Acronym
Research on improving resilience and psychological safety using electronic information system
Scientific Title
Research project on confirmation of the improvement of resilience, psychological safety and medical safety using electronic information system
Scientific Title:Acronym
Research on improving resilience and psychological safety using electronic information system
Region
| Japan |
Condition
Condition
Prevention of mental illness
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
At this time, we have been able to confirm data that one individual factor (resilience) and one organizational factor (psychological safety) improve individually in hospitals that have actually implemented the electronic information system used in this study.
However, we have not been able to identify the factors associated with improvements in resilience and psychological safety. In addition, it is difficult to conduct assessments to identify factors related to resilience and psychological safety in hospitals that currently have electronic information systems, because they are not implementing electronic information systems for research purposes.
This project aims to demonstrate the following
The project aims to
demonstrate the following:
- Identification of factors related to resilience and psychological safety
- Clarification of the impact of related factors on the amount of improvement in resilience and psychological safety
- Improvement in resilience and psychological safety will lead to positive outcomes for healthcare professionals, such as prevention of depression, improvement in wellbeing, and improvement in indicators of unwellness. Positive outcomes for healthcare professionals, such as preventing depression, improving wellbeing, and improving indices of aunwellness, as a result of improved resilience and psychological safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological safety must improve by at least 10% before and after the 6-week intervention.
Key secondary outcomes
Resilience to improve by at least 3% before and after the 4-week intervention.
The improvement in psychological safety and resilience is smaller when overtime hours are high.
The improvement in psychological safety and resilience is smaller when workload is high.
The improvement in psychological safety and resilience is smaller when stress is high.
Depression improves by 10% or more.
Improvement of the unwellness index by 10% or more.
Intention to leave a job decreases by at least 10%.
An improvement in the distribution of incident reports.
An improved sense of mutual support among health care providers.
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
| Other |
Interventions/Control_1
The demonstration period will be 20 weeks.
Assessment will be conducted at the beginning. Resilience intervention will be conducted for the first 4 weeks. At the beginning of the intervention, the intervention group will receive an explanation of resilience and the electronic information system, and will enter their goals for improving resilience into the electronic information system. For the next four weeks, participants use the electronic information system and receive feedback on their input and input into the system. Participants will use the system at least once a week for a maximum of two minutes per session, and will be assessed after four weeks.
In consideration of the burden on the project participants, there will be a 4-week period between the resilience intervention and the psychological safety intervention.
Assessment will be conducted 4 weeks after the resilience intervention is completed.
Thereafter, the psychological safety intervention will be conducted for 6 weeks. The intervention group will be briefed on psychological safety and the electronic information system at the start and will enter their goals for improving psychological safety into the electronic information system. For the next six weeks, participants use the electronic information system and receive feedback on their input and input into the system. Participants use the electronic information system at least once a week for a maximum of two minutes per session.
An assessment will be conducted 6 weeks after the psychological safety intervention is completed; the reason for conducting the assessment at 6 weeks is to identify changes over time since the end of the intervention, and the measurement will be taken after a period of time equivalent to the duration of the psychological safety intervention.
In addition, interviews with department heads will be conducted via web meetings at Weeks 0 and 20.
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A healthcare professional working at a medical institution.
Must own a smartphone and be able to install and use the specified application during the study.
Key exclusion criteria
Persons who do not work for a medical institution or are not a health care provider.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Shimoda |
Organization
World Life Mapping Inc.
Division name
headquarters
Zip code
305-0031
Address
Tsukuba Industrial Promotion Center, 2-5-1 Azuma, Tsukuba City, Ibaraki Prefecture, Japan
TEL
08056723374
as@cibylink.com
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Fukuda |
Organization
World Life Mapping Inc.
Division name
headquarters
Zip code
305-0031
Address
Tsukuba Industrial Promotion Center, 2-5-1 Azuma, Tsukuba City, Ibaraki Prefecture, Japan
TEL
08056723374
Homepage URL
sa@cibylink.com
Sponsor or person
Institute
World Life Mapping Inc.
Institute
Department
Personal name
Akira Shimoda
Funding Source
Organization
World Life Mapping Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanagawa Prefectural Government
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Community Health Plan, a non-profit organization
Address
Tongari Building 3F, 2-7-23 Nanokaicho, Yamagata City
Tel
-
y.aita@cikop-snc.com
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
| 2025 | Year | 02 | Month | 15 | 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
| 2024 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 02 | Month | 03 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065052
