UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046168 |
|---|---|
| Receipt number | R000052694 |
| Scientific Title | A pharmacist-delivered smoking cessation program in community pharmacy: A Cluster Randomized Controlled Trial |
| Date of disclosure of the study information | 2022/01/31 |
| Last modified on | 2021/11/24 19:10:38 |
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Basic information
Public title
A pharmacist-delivered smoking cessation
program in community pharmacy: A Cluster
Randomized Controlled Trial
Acronym
FINE project (R)
(Family pharmacist's Intervention for
Nicotine Elimination: Refined)
Scientific Title
A pharmacist-delivered smoking cessation
program in community pharmacy: A Cluster
Randomized Controlled Trial
Scientific Title:Acronym
FINE project (R)
(Family pharmacist's Intervention for
Nicotine Elimination: Refined)
Region
| Japan |
Condition
Condition
Smokers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of the pharmacist-delivered smoking cessation program on smoking
cessation in community pharmacies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Quit rate in the last 7 days (self-reported)
Key secondary outcomes
Quit rate in the past 30 days (self-reported)
Biochemically confirmed smoking cessation rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
1) Setting the target goal
2) Assessment and counseling for smoking
cessation along with medication counseling
3) Regular follow-up by telephone or other means (minimum 6 times)
4) Providing information and Support using newly developed Support materials
5) Explanation and medication counseling
of smoking cessation aids
Interventions/Control_2
1)Provision of information using ready-made leaflets and other materials
2)Explanation and guidance on the use of smoking cessation aids
3)Confirmation of no smoking when visiting the office (once)
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) People who have a prescription for the
treatment of any chronic disease.
2) Person who are expected to visit community pharmacy over 8 weeks
3) Person who agree to receive smoking cessation program
Key exclusion criteria
1) Dementia or psychiatric disorders
2) Allergies or adverse effects with smoking cessation aids
3) Temporomandibular Joint Disorder (in the case of nicotine gum)
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Mitsuko |
| Middle name | |
| Last name | Onda |
Organization
Faculty of Pharmacy, Osaka Medical and Pharmaceutical University
Division name
Department of Social and Administrative Pharmacy
Zip code
569-1094
Address
4-20-1 Nasahara, Takatsuki, Osaka, Japan
TEL
+81-72-690-1059
mitsuko.onda@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuko |
| Middle name | |
| Last name | Onda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Pharmacy
Zip code
569-194
Address
4-20-1 Nasahara, Takatsuki, Osaka, Japan
TEL
+81-72-690-1059
Homepage URL
mitsuko.onda@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Hospital Organization
Kyoto Medical Center(Clinical Research
Center)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics review Committee of Osaka Medical and Pharmaceutical University
Address
4-20-1 Nasahara, Takatsuki, Osaka, Japan
Tel
+81-72-690-1103
p-kenkyus@ompu.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 | 01 | Month | 31 | 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
| 2022 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 24 | Day |
Last modified on
| 2021 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052694
