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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name