UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056920 |
|---|---|
| Receipt number | R000065050 |
| Scientific Title | Adaptation of interactive assistance via eHealth for small and medium-sized enterprises' employer and health care manager teams on tobacco control (eSMART-TC) and feasibility study of the intervention for eSMART-TC implementation support (N-EQUITY2403) |
| Date of disclosure of the study information | 2025/02/03 |
| Last modified on | 2026/02/10 15:11:58 |
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Basic information
Public title
Adaptation of interactive assistance via eHealth for small and medium-sized enterprises' employer and health care manager teams on tobacco control (eSMART-TC) and feasibility study of the intervention for eSMART-TC implementation support (N-EQUITY2403)
Acronym
Adaptation of eSMART-TC and feasibility study
Scientific Title
Adaptation of interactive assistance via eHealth for small and medium-sized enterprises' employer and health care manager teams on tobacco control (eSMART-TC) and feasibility study of the intervention for eSMART-TC implementation support (N-EQUITY2403)
Scientific Title:Acronym
Adaptation of eSMART-TC and feasibility study
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the feasibility of the intervention for eSMART-TC implementation support (intervention for program providers to implement the Kumamoto Program)
*The Kumamoto Program refers to a program in which the eSMART-TC program has been adapted to tailor the regional and transport/construction industry characteristics.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Fidelity of Kumamoto Program implementation by program providers at the end of the program
Key secondary outcomes
1.Program provider (intervention targets):
-Factors inhibiting implementation of the Kumamoto Program
-Professional performance related to supporting the implementation of workplace tobacco control
-Differences between the procedures in the workbook and the actual Kumamoto Program
-Acceptability of the Kumamoto Program
-Appropriateness of the Kumamoto Program
-Feasibility of the Kumamoto Program
-Confidence in implementing the Kumamoto Program (self-efficacy)
2.Employers (program participants):
-Extent to which the employers implement the recommendations of the Kumamoto Program
3.Health managers (program participants):
-Extent to which health managers implement the Kumamoto Program's recommendations
4.Employees (program participating enterprises):
-Proportion of employees who visited smoking cessation clinics and purchased smoking cessation aids
-Proportion of employees who tried to quit smoking, and proportion of employees who quit smoking
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
| Behavior,custom |
Interventions/Control_1
1.Training for interactive assistance in tobacco control
2.Provision of a tobacco control checklist and the associated checklist manual
3.Provision of a workplace tobacco control workbook
4.Explanatory booklet on workplace tobacco control
5.Provision of educational materials for enterprises
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Affiliation with the Kumamoto branch of the Japan Health Insurance Association
2. Having a public health nurse or a registered dietitian qualification
3. Responsible for supporting the implementation of health promotion measures at workplaces
4. Experience in occupational health nursing
5. Provision of consent to participate in this study
Key exclusion criteria
Determination by a superior that implementation is infeasible due to the burden of original work
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Shimazu |
Organization
National Cancer Center Institute for Cancer Control, National Cancer Center, Japan
Division name
Division of Behavioral Sciences
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL
03-3547-5201
tshimazu@ncc.go.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Saito |
Organization
National Cancer Center Institute for Cancer Control, National Cancer Center, Japan
Division name
Division of Behavioral Sciences
Zip code
104-0015
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL
0335475201
Homepage URL
jsaito@ncc.go.jp
Sponsor or person
Institute
National Cancer Center, Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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 | 02 | Month | 03 | 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
5
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | 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
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065050
