UMIN-CTR Clinical Trial

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	A pharmacist-delivered smoking cessation program in community pharmacy: a cluster-randomized trial
Publication of results	Unpublished

Result
URL related to results and publications	https://doi.org/10.1155/2021/9983515
Number of participants that the trial has enrolled	24
Results	572 smokers who met the eligibility criteria visited the target pharmacies. Of these, 24 patients agreed to participate in the study. Smoking cessation rates were 45.5% in the intervention group and 18.2% in the control group (P = 0:380, effect size = 0:60).
Results date posted	2022 Year 04 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Smokers aged 20 years or older who receive prescription medicines at pharmacies participating in the study and who are able to visit the pharmacy for a continuous period of three months
Participant flow	After receiving an explanation about the study from the pharmacist and agreeing to participate, participants received smoking cessation support through the FINE programme in the intervention group and usual support in the control group
Adverse events	No adverse events occurred during the study period.
Outcome measures	The primary endpoint was participants who had quit smoking at the end of the 3-month follow-up period (3-month quit rate).
Plan to share IPD	No data sharing plan for individual cases
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	2022 Year 04 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036576