UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061169 |
|---|---|
| Receipt number | R000069998 |
| Scientific Title | Development and Evaluation of a Participatory Program for Building Workplace Connectedness |
| Date of disclosure of the study information | 2026/04/06 |
| Last modified on | 2026/04/06 15:07:43 |
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Basic information
Public title
Development and Evaluation of a Participatory Program for Building Workplace Connectedness
Acronym
Participatory Workplace Connectedness Program
Scientific Title
Development and Evaluation of a Participatory Program for Building Workplace Connectedness
Scientific Title:Acronym
Participatory Workplace Connectedness Program
Region
| Japan |
Condition
Condition
Workplace loneliness and social isolation
Classification by specialty
| Psychosomatic Internal Medicine | Nursing | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop and evaluate a participatory program for building workplace connectedness, based on the framework of participatory workplace environment improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in workplace loneliness measured by the Scale for Loneliness at Work (SLAW)
Key secondary outcomes
Change in psychological distress measured by the K6 scale
Change in work engagement measured by the Utrecht Work Engagement Scale (UWES)
Change in workplace social capital
Change in perceived supervisor and coworker support
Change in work productivity (presenteeism)
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
Intervention:
A participatory program for building workplace connectedness based on the participatory workplace environment improvement approach.
Duration:
Approximately 6 months (3-month intervention period and 3-month follow-up period)
Frequency and number of sessions:
Workplace session (group discussion): once per workplace (approximately 60 minutes)
Feedback/presentation session: once per workplace (approximately 60 minutes)
Implementation of action plans: ongoing during routine work for approximately 3 months
Intervention components:
The program consists of four steps:
Preparation and individual assessment
Participants complete an action checklist to reflect on their workplace environment prior to the group session.
Workplace session (group discussion)
Participants review workplace practices using good practice examples and an action checklist, followed by small group discussions to identify improvement actions.
Development and implementation of action plans
Each workplace develops feasible, low-cost improvement plans and implements them over approximately 3 months.
Feedback/presentation session
Participants share the outcomes and challenges of the implemented improvements and discuss future directions for workplace development.
Implementation:
The program is facilitated by the principal investigator, while employees take the lead in identifying and implementing improvements. Standardized tools and procedures are used across all workplaces.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
Employees who continue working in the intervention workplace throughout the intervention period
Non-managerial employees
Those who provide consent to complete the questionnaires before and after the intervention
Participating workplaces must be able to implement participatory workplace environment improvement activities at the workplace level, cooperate with web-based surveys before and after the intervention, and have an occupational health consultation system available.
Key exclusion criteria
Participants meeting any of the following criteria will be excluded:
Individuals who are unable to complete questionnaires written in Japanese
Individuals who are on sick leave, childcare leave, or caregiving leave and do not have work attendance during the intervention period
Individuals who are transferred to another workplace or company during the intervention period
Managerial employees
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Yoshikawa |
Organization
Japanese Red Cross College of Nursing
Division name
Faculty of Nursing
Zip code
1500012
Address
4-1-3, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
0334090875
e-yoshikawa@redcross.ac.jp
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Yoshikawa |
Organization
Japanese Red Cross College of Nursing
Division name
Faculty of Nursing
Zip code
1500012
Address
4-1-3, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
0334090875
Homepage URL
e-yoshikawa@redcross.ac.jp
Sponsor or person
Institute
Japanese Red Cross College of Nursing
Institute
Department
Personal name
Funding Source
Organization
JITS RISTEX
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross College of Nursing
Address
4-1-3, Hiroo, Shibuya-ku, Tokyo, Japan
Tel
0334090875
e-yoshikawa@redcross.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
| 2026 | Year | 04 | Month | 06 | 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
| 2026 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069998
