UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063071 |
|---|---|
| Receipt number | R000072205 |
| Scientific Title | Development of an Evaluation Method and Implementation Strategy for Municipal Tobacco Control Utilizing a Logic Model |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 13:13:56 |
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Basic information
Public title
Development of an Evaluation Method and Implementation Strategy for Municipal Tobacco Control Utilizing a Logic Model
Acronym
Feasibility Evaluation Study of the Implementation Support Tool for Municipal Tobacco Control (J-LogiNav Study)
Scientific Title
Development of an Evaluation Method and Implementation Strategy for Municipal Tobacco Control Utilizing a Logic Model
Scientific Title:Acronym
Feasibility Evaluation Study of the Implementation Support Tool for Municipal Tobacco Control (J-LogiNav Study)
Region
| Japan |
Condition
Condition
Not applicable (Municipal public health personnel responsible for tobacco control)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop and evaluate the validity, feasibility, and implementation outcomes of a web-based implementation support tool, the Japanese Community-Based Tobacco Control Implementation Navigator (J-LogiNav), designed to comprehensively support local governments from situational assessment to action planning in alignment with Health Japan 21 (the third term). Targeting municipal personnel responsible for tobacco control, this observational study evaluates the tool's prototype and finalized versions using web-based surveys, system usage logs, and interviews to assess acceptability, appropriateness, feasibility, and intention to adopt, thereby identifying implementation determinants and optimizing the system for local public health practice.
Basic objectives2
Others
Basic objectives -Others
Feasibility and usability evaluation of the tool
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Evaluation of the 15-item Tobacco Control Best Buy Checklist (perceived appropriateness and feasibility within municipal settings)
2.Implementation outcomes of the web-based implementation support tool, including Acceptability, Appropriateness, Feasibility, and Intention to Adopt/Sustain.
Key secondary outcomes
1.System usage log metrics (frequency of access, specific feature usage, and duration of use)
2.Qualitative feedback on system usability, barriers, and user recommendations for tool refinement gathered via open-ended questionnaire items and optional semi-structured interviews.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Public health nurses, nursing professionals, or municipal administrative officers engaged in tobacco control or lifestyle disease prevention planning within local governments
2. Individuals who understand the study objectives and provide informed consent
Key exclusion criteria
1. Individuals without access to the necessary web environment (internet connection and supported browsers) required for tool operation
2. Individuals who do not provide informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Chikako |
| Middle name | |
| Last name | Michibayashi |
Organization
Gifu University of Medical Science
Division name
Department of Nursing, Faculty of Nursing
Zip code
509-0261
Address
4-3-3 Nijigaoka, Kani, Gifu
TEL
0574656555
cmichibayashi@u-gifu-ms.ac.jp
Public contact
Name of contact person
| 1st name | Chikako |
| Middle name | |
| Last name | Michibayashi |
Organization
Gifu University of Medical Science
Division name
Department of Nursing, Faculty of Nursing
Zip code
509-0261
Address
4-3-3 Nijigaoka, Kani, Gifu
TEL
0574656555
Homepage URL
cmichibayashi@u-gifu-ms.ac.jp
Sponsor or person
Institute
Gifu University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant Number JP25K14259
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
Secretariat of Research Ethics Committee, Gifu University of Medical Sciences
Address
4-3-3 Nijigaoka, Kani-shi, Gifu, Japan
Tel
0574656555
kenkyu@u-gifu-ms.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 | 09 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants are provided with access to the web-based implementation support tool "J-LogiNav" to review screens and test features of both prototype and finalized versions. Following tool usage, participants complete a web-based evaluation questionnaire regarding appropriateness, feasibility, and acceptability, with optional follow-up interviews and system log data collection.
Management information
Registered date
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072205
