UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052573 |
|---|---|
| Receipt number | R000059065 |
| Scientific Title | Supporting Smoking Cessation for Tuberculosis Patients: One-Group Pretest-Posttest Design |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2025/04/24 10:32:08 |
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Basic information
Public title
Supporting Smoking Cessation for Tuberculosis Patients: One-Group Pretest-Posttest Design
Acronym
Supporting Smoking Cessation for Tuberculosis Patients: One-Group Pretest-Posttest Design
Scientific Title
Supporting Smoking Cessation for Tuberculosis Patients: One-Group Pretest-Posttest Design
Scientific Title:Acronym
Supporting Smoking Cessation for Tuberculosis Patients: Prospective Intervention Study and Retrospective Observational Study
Region
| Japan |
Condition
Condition
tuberculosis
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of supporting smoking cessation in tuberculosis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
smoking cessation rate
Key secondary outcomes
Predictors of smoking cessation achievement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Supporting Smoking Cessation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Retrospective observational study: Patients aged 20 years or older who were admitted to the Tuberculosis Unit of the National Hospital Organization Kinki-Chuo Chest Medical Center between April 1, 2021 and March 31, 2024, and who attended as outpatients after discharge from the hospital were selected.
(2) Prospective intervention study: Patients aged 20 years or older who were admitted to the TB ward of the National Hospital Organization Kinki-Chuo Chest Medical Center on or after April 1, 2024, and who attended the hospital as outpatients after discharge were selected.
Key exclusion criteria
Patients under 20 years of age
Patients who are unable to understand smoking cessation instructions due to dementia, advanced age, or other reasons
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Kurahara |
Organization
National Hospital Organization Kinki-Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
591-8555
Address
1180, Nagasone-Cho, Kita-Ku, Sakai City, Osaka
TEL
+81-72-252-3021
krawelts@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Kurahara |
Organization
National Hospital Organization Kinki-Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
591-8555
Address
1180, Nagasone-Cho, Kita-Ku, Sakai City, Osaka
TEL
+81-72-252-3021
Homepage URL
krawelts@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Kinki-Chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kinki-Chuo Chest Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kinki-Chuo Chest Medical Center
Address
1180, Nagasone-Cho, Kita-Ku, Sakai City, Osaka
Tel
+81-72-252-3021
krawelts@yahoo.co.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 | 10 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Currently Registering
Management information
Registered date
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059065
