UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048212 |
|---|---|
| Receipt number | R000054940 |
| Scientific Title | Randomized controlled trial of a smoking cessation support program for middle-aged and older men with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2023/06/30 23:04:47 |
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Basic information
Public title
Development and implementation of a smoking cessation support program for middle-aged and older men with chronic obstructive pulmonary disease
Acronym
Development of a smoking cessation support program for middle-aged and older men with chronic obstructive pulmonary disease
Scientific Title
Randomized controlled trial of a smoking cessation support program for middle-aged and older men with chronic obstructive pulmonary disease
Scientific Title:Acronym
Randomized controlled trial of a smoking cessation support program for middle-aged and older men with chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Test the effectiveness of a smoking cessation support program developed for this study in middle-aged and older men with chronic obstructive pulmonary disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of smokers who quit smoking 24 weeks after from the first consultation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Research subjects will receive a smoking cessation program covered by medical insurance (5 sessions in 12 weeks) plus 2 online interviews to provide additional smoking cessation support.
Interventions/Control_2
Control group: Research subjects receive only medically insured outpatient smoking cessation (5 sessions in 12 weeks) and no additional smoking cessation support program.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Males over 50 years of age who are currently visiting a smoking cessation clinic and have been diagnosed with chronic obstructive pulmonary disease
Key exclusion criteria
Persons with severe mental illness or cognitive impairment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | YAMAMURA |
Organization
Sophia University
Division name
Faculty of human sciences, department of nursing
Zip code
161-8550
Address
Shinjuku city, Shimoochiai 4-16-11, Tokyo, Japan
TEL
+81-3-3950-6931
t-yamamura@sophia.ac.jp
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | YAMAMURA |
Organization
Sophia University
Division name
Faculty of human sciences, faculty of nursing
Zip code
161-8550
Address
Shinjuku city, Shimoochiai 4-16-11, Tokyo, Japan
TEL
+81-3-3950-6931
Homepage URL
t-yamamura@sophia.ac.jp
Sponsor or person
Institute
Sophia University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sophia University for Human Research Ethics Committee
Address
Chiyoda city, Kioicho 7-1, Tokyo, Japan
Tel
+81-3-3238-3173
rhs-rinri-co@sophia.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
| 2022 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054940
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
