UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044526 |
|---|---|
| Receipt number | R000050597 |
| Scientific Title | Interactive assistance via eHealth for small and medium-sized enterprises' employer and health care manager teams on tobacco control (N-EQUITY2101/J-SUPPORT2102) |
| Date of disclosure of the study information | 2021/06/17 |
| Last modified on | 2023/12/18 13:01:55 |
* 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
Interactive assistance via eHealth for small and medium-sized enterprises' employer and health care manager teams on tobacco control (N-EQUITY2101/J-SUPPORT2102)
Acronym
eSMART-TC
Scientific Title
Interactive assistance via eHealth for small and medium-sized enterprises' employer and health care manager teams on tobacco control (N-EQUITY2101/J-SUPPORT2102)
Scientific Title:Acronym
eSMART-TC
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether interactive six-month support interventions promoting the implementation of tobacco control measures by employers and health managers through sessions using behavioral change techniques increase successful smoking cessation compared to the absence of such interventions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Seven-day point-prevalence abstinence at six months after the intervention (information provision for control groups)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group
The interventionist will offer interactive support to employers and health managers (person overseeing health management) during six-month periods. This support will be predominantly conducted through web-based sessions, to encourage the implementation of evidence-based tobacco control measures: (1) smoking cessation treatment according to the relevant standard procedures and (2) smoke-free workplaces.
The intervention period lasted for six months, with five sessions (maximum of nine) for employers and 10 sessions (maximum of 15) for health managers.
Interventions/Control_2
Control group
The interventionist will offer information on evidence-based tobacco control measures regarding (1) smoking cessation treatment according to the relevant standard procedures and (2) smoke-free workplaces.
Regarding usual care, the health nurses of the Japan Health Insurance Association (JHIA) will support workplace health promotion and provide individual health guidance for target people.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for enterprises
1. In business for more than three years.
2. A small or medium-sized enterprise or a branch or business office of an enterprise, with 30-300 employees.
3. Have already entered the Health Declaration conducted by a branch of the JHIA.
4. Both the employer and the health manager are aged 20 years or older.
5. Facilities for conducting web-based sessions are available in the workplace.
6. The employer's consent to participate in the study has been obtained.
7. There is a high level of readiness to implement tobacco control measures.
The definition of a high level of readiness:
- The employer is available to participate in sessions with the interventionist: two to three sessions (30 minutes to an hour) during the first two months of the intervention.
- The health manager is available to participate in sessions with the interventionist: once a week for the first three months of the intervention, and twice a month from the fourth to the sixth month.
- The health manager can set time aside to implement the measures.
Inclusion criteria for intervention targets
Employers
1. 20 years old or older.
2. Able to read, write, and understand Japanese.
3. High level of readiness to implement tobacco control measures: There is a strong desire to actively promote tobacco control measures as part of the health declaration program.
4. Provided written consent for participation in the study.
Health managers
1. 20 years old or older.
2. Able to read, write, and understand Japanese.
3. Involved in fostering health management and health promotion among employees.
4. Has provided written consent for participation in the study.
Key exclusion criteria
Employers and health managers who belong to any of the following categories are ineligible:
Those who have already decided to move or change jobs within the next year and leave their current enterprise.
Those who are deemed unsuitable by the JHIA branch office for participating in this study.
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Shimazu |
Organization
National Cancer Center Institute for Cancer Control
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
Division name
Division of Behavioral Sciences
Zip code
104-0015
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL
03-3547-5201(ext.3319)
Homepage URL
jsaito@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Institute for Cancer Control
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
Japan
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
| 2021 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
https://implementationsciencecomms.biomedcentral.com/articles/10.1186/s43058-023-00444-0
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
3181
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
| 2021 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 08 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | 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=R000050597
