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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032063
Receipt No. R000036576
Scientific Title A pharmacist-delivered smoking cessation program in community pharmacy: a cluster-randomized trial
Date of disclosure of the study information 2018/05/01
Last modified on 2019/03/13

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Basic information
Public title A pharmacist-delivered smoking cessation program in community pharmacy: a cluster-randomized trial
Acronym FINE project (Family pharmacist's Intervention for Nicotine Elimination)
Scientific Title A pharmacist-delivered smoking cessation program in community pharmacy: a cluster-randomized trial
Scientific Title:Acronym FINE project (Family pharmacist's Intervention for Nicotine Elimination)
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

Assessment
Primary outcomes Carbon Monoxide-verified Abstinence or Color reaction of YANIKEN-verified Abstinence [ Time Frame: Week 12]
Key secondary outcomes 1) Number of recommended cases to a smoking cessation clinic and visiting cases
2) Satisfaction score with pharmacist-delivered smoking cessation program
3) Recommendation score with pharmacist-delivered smoking cessation program

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) Telephone-delivered counseling
4) Giving information using support materials
5) Explanation and medication counseling of smoking cessation aids
Interventions/Control_2 Usual care by pharmacist
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) Person who taking medications
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)
4) Pregnant women
Target sample size 84

Research contact person
Name of lead principal investigator
1st name Mitsuko
Middle name
Last name Onda
Organization Osaka University of Pharmaceutical Sciences
Division name Department of Social and Administrative Pharmacy
Zip code 569-1041
Address 4-20-1 Nasahara, Takatsuki, Osaka
TEL +81-72-690-1059
Email onda@gly.oups.ac.jp

Public contact
Name of contact person
1st name Mitsuko
Middle name
Last name Onda
Organization Osaka University of Pharmaceutical Sciences
Division name Department of Social and Administrative Pharmacy
Zip code 569-1041
Address 4-20-1 Nasahara, Takatsuki, Osaka
TEL +81-72-690-1059
Homepage URL
Email onda@gly.oups.ac.jp

Sponsor
Institute Osaka University of Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Osaka University of Pharmaceutical Sciences
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 Osaka University of Pharmaceutical Sciences
Address 4-20-1, Nasahara, Takatsuki, Osaka, Japan
Tel +81-72-690-1103
Email kenkyus@gly.oups.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
2018 Year 05 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 24
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
2018 Year 03 Month 30 Day
Date of IRB
2018 Year 03 Month 30 Day
Anticipated trial start date
2018 Year 04 Month 15 Day
Last follow-up date
2019 Year 12 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
2018 Year 04 Month 02 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036576

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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