UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050135 |
|---|---|
| Receipt number | R000057117 |
| Scientific Title | Effectiveness of Support Program for Balancing Treatment and Work in SMEs Promoted by Occupational Health Nurses using Web Meeting System: A Cluster RCT study |
| Date of disclosure of the study information | 2023/01/25 |
| Last modified on | 2023/01/25 19:28:00 |
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Basic information
Public title
Effectiveness of Support Program for Balancing Treatment and Work in Small and Medium-sized Enterprises Promoted by Occupational Health Nurses using Web Meeting System: A Cluster Randomized Controlled Trial study
Acronym
Effectiveness of Support Program for Balancing Treatment and Work in SMEs Promoted by Occupational Health Nurses using Web Meeting System: A Cluster RCT study
Scientific Title
Effectiveness of Support Program for Balancing Treatment and Work in SMEs Promoted by Occupational Health Nurses using Web Meeting System: A Cluster RCT study
Scientific Title:Acronym
Effectiveness of Support Program for Balancing Treatment and Work in SMEs Promoted by Occupational Health Nurses using Web Meeting System: A Cluster RCT study
Region
| Japan |
Condition
Condition
NONE
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to verify the effectiveness of a treatment-work balance support (TWBS) program promoted by occupational health nurses (OHNs) in small and medium-sized enterprises (SMEs) while utilizing web meeting system by using a cluster randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recognition and Attitude Scale for TWBS in SMEs were measured.
Key secondary outcomes
Psychological safety and work engagement were measured as a safe and active workplace. For the endpoint only, we also asked about changes in awareness regarding TWBS.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention
The intervention was conducted by an OHN with at least 13 years of experience in TWBS at large companies and SMEs, and with qualifications such as OHN specialist and TWBS coordinator. The design of the TWBS program was repeatedly discussed by two researchers with more than 10 years of experience as OHNs. The cartoons and the TWBS program were revised based on the feedback received from managers and workers at the companies targeted in the preliminary study21 and from OHNs and oncology nurses. (Table 1)
Online consultation with managers in the intervention group were conducted once a month for 60 minutes, for four times over a five-month period (Table 1). During the second and third rounds of support, we provided feedback and advice on the results of the baseline survey, reviewed the company's health issues and internal resources. Furthermore, in the fourth round, we proposed the creation of internal systems for continued TWBS and introduced the Prefectural Occupational Health Support Center (OH center). Between the second and third support sessions, managers and workers attended a 40-minute seminar on TWBS using the TWBS cartoon developed by the authors. The seminar was offered in either online or face-to-face formats.
Interventions/Control_2
All workers and managers of the control and intervention group received a leaflet with information on external resources for TWBS.
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
| 18 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participants of the study were executives, human resource staffs (managers) and workers of SMEs in the Kanto and Tokai regions, with a workforce between 20 and 200, construction and manufacturing industries, no OHNs were employed, certified as Health and Productivity Management Organization the Ministry of Economy, Trade and Industry or equivalent.
Key exclusion criteria
Everything but the selection criteria.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Abe |
Organization
Tokai University
Division name
Graduate School of Medicine Course of Advanced Medical Science
Zip code
259-1193
Address
143 Shimokasuya, Isehara city, Kanagawa 259-1193 Japan Tokai University.
TEL
0463-93-1121
0cmud002@cc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Abe |
Organization
Tokai University
Division name
Graduate School of Medicine Course of Advanced Medical Science
Zip code
259-1193
Address
143 Shimokasuya, Isehara city, Kanagawa 259-1193 Japan Tokai University.
TEL
0463-93-1121
Homepage URL
0cmud002@cc.u-tokai.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Course of Advanced Medical Science, Tokai University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine Course of Advanced Medical Science, Tokai University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research of Tokai University
Address
143 Shimokasuya, Isehara city, Kanagawa 259-1193 Japan Tokai University. Institutional Review Board for Clinical Research of Tokai University
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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 | 01 | Month | 25 | 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
22
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
Terminated
Date of protocol fixation
| 2021 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 05 | 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 | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057117
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| Registered date | File name |
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