UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032063 |
|---|---|
| Receipt number | 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 | 2022/04/05 09:42:30 |
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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
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
onda@gly.oups.ac.jp
Sponsor or person
Institute
Osaka University of Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036576
| Research Plan | |
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| 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 |
