UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060127 |
|---|---|
| Receipt number | R000068767 |
| Scientific Title | A Feasibility Study of a Mobile Application for Promoting Workplace Well-being Among Healthcare Professionals at St. Marianna University Hospital |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/12/18 23:22:02 |
* 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
A Feasibility Study of a Mobile Application for Promoting Workplace Well-being Among Healthcare Professionals at St. Marianna University Hospital
Acronym
SMUH Workplace Well-being Project
Scientific Title
A Feasibility Study of a Mobile Application for Promoting Workplace Well-being Among Healthcare Professionals at St. Marianna University Hospital
Scientific Title:Acronym
SMUH Workplace Well-being Project
Region
| Japan |
Condition
Condition
healthcare professionals working at St. Marianna University Hospital
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to preliminarily evaluate the feasibility of a mobile application, eMind for Business, customized for healthcare professionals at St. Marianna University Hospital, to promote mental health and well-being in the workplace.
This study will assess the acceptability of the application (installation and usage rates) and its perceived usefulness (subjective evaluations and effects on work-related and psychological outcomes), to conduct an initial examination of its practicality and utility for implementation among healthcare professionals.
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Application Installation Rate
The proportion of participants who installed the application during the study period among the total number of study participants. This outcome indicates the acceptability of the intervention.
2) Application Usage Rate
The proportion of participants who used the application at least three times during the 12-week study period from baseline among those who installed the application. This rate will be calculated based on application log data (number of logins, number of usage sessions, and frequency of function use) and reflects sustained acceptability and practical usability.
Key secondary outcomes
Secondary Outcomes
1 Workplace well-being measures, including overall satisfaction with the workplace and job; domain-specific satisfaction (interpersonal relationships, communication, organizational systems, training, support, and intention to continue working); satisfaction with life outside of work; overall enjoyment and meaningfulness of life; and work engagement.
2 Depressive symptom severity, assessed using the Quick Inventory of Depressive Symptomatology-Japanese version (QIDS-J).
3 Self-rated health status during the past month, including sleep sufficiency and physical condition.
4 Burnout level.
5 Presenteeism.
6 Mental well-being during the past two weeks, assessed using the World Health Organization-Five Well-Being Index (WHO-5).
7 Expectations regarding the Workplace Well-being Project and attitudes toward participation in the project.
8 Application evaluation, including utilized functions, perceived effectiveness, and user feedback.
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
| Other |
Interventions/Control_1
Study participants will download the mobile application eMind for Business to their own smartphones. The application is designed to promote mental health and well-being in the workplace. During the intervention period, participants may use the following functions at their discretion: (1) a stress coping consultation function (AnyTalk) and (2) a health monitoring function (HeartPoint).
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Healthcare professionals working at St. Marianna University Hospital, including physicians, nurses/midwives, and pharmacists.
2 Individuals aged 20 years or older and under 75 years at the time of study enrollment.
3 Individuals who own a smartphone capable of installing the study application.
4 Individuals who are able to provide written informed consent to participate in the study.
Key exclusion criteria
1. Individuals for whom continued participation until the end of the intervention period is clearly difficult, such as those planning to resign or leave their position in the near future.
2. Individuals whom the investigators judge to be unsuitable for study participation due to health conditions or safety concerns.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Atsuo |
| Middle name | |
| Last name | Nakagawa |
Organization
St. Marianna University School of Medicine
Division name
Dept of Neuropsychiatry
Zip code
216-8511
Address
216-8511
TEL
044-977-8111
atsuo.nakagawa@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuo |
| Middle name | |
| Last name | Nakagawa |
Organization
St. Marianna University School of Medicine
Division name
Dept of Neuropsychiatry
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki
TEL
044-977-8111
Homepage URL
atsuo.nakagawa@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
St. Marianna University School of Medicine
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki
Tel
044-977-8111
atsuo.nakagawa@marianna-u.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
| 2025 | Year | 12 | Month | 31 | 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
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2027 | 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 | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068767
