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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044380
Receipt No. R000050696
Scientific Title Assessment of community pharmacies' support for smoking cessation treatment in collaboration with medical institutions
Date of disclosure of the study information 2021/06/01
Last modified on 2021/05/31

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Basic information
Public title Assessment of community pharmacies' support for smoking cessation treatment in collaboration with medical institutions
Acronym Assessment of community pharmacies' support for smoking cessation treatment in collaboration with medical institutions
Scientific Title Assessment of community pharmacies' support for smoking cessation treatment in collaboration with medical institutions
Scientific Title:Acronym Assessment of community pharmacies' support for smoking cessation treatment in collaboration with medical institutions
Region
Japan

Condition
Condition Smoking cessation
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will evaluate whether telephone follow-up by community pharmacists to outpatients undergoing smoking cessation treatment can enhance the effectiveness of smoking cessation treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes smoking cessation treatment completion rates, smoking cessation success rates, smoking cessation persistence rates
Key secondary outcomes Satisfaction

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Smoking cessation treatment completion rate, smoking cessation success rate, and smoking cessation persistence rate for patients who received telephone support in addition to a total of four medication guidance during approximately 12 weeks of smoking cessation treatment.
1.Telephone support is provided 4 times in the middle of the day before the next scheduled visit to the clinic.
2. If any side effects are found, Pharmacists will respond to them according to the protocol.
Interventions/Control_2
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. Patients being prescribed a smoking cessation drug for the first time
2. Patients who visit clinics where the research co-investigator works and bring a prescription issued by clinics to the research co-investigator's pharmacy
Key exclusion criteria 1. Patients in the hospital
2. Patients continuing smoking cessation treatment
3. Men and women under the age of 20
4. Patients who did not get their consent to participate in the study
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Fumiyuki
Middle name
Last name Watanabe
Organization School of Pharmacy, Nihon University
Division name Pharmacy practice in primary care
Zip code 274-8555
Address 7-7-1 Narashinodai, Funabashi, Chiba Japan
TEL 047-465-7394
Email watanabe.fumiyuki@nihon-u.ac.jp

Public contact
Name of contact person
1st name Fumiyuki
Middle name
Last name Watanabe
Organization School of Pharmacy, Nihon University
Division name Pharmacy practice in primary care
Zip code 274-8555
Address 7-7-1 Narashinodai, Funabashi, Chiba Japan
TEL 047-465-7394
Homepage URL
Email watanabe.fumiyuki@nihon-u.ac.jp

Sponsor
Institute School of Pharmacy, Nihon University
Institute
Department

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 Ethics Review Committee, School of Pharmacy, Nihon University
Address 7-7-1 Narashinodai, Funabashi, Chiba Japan
Tel 047-465-5919
Email pha.res-staff@nihon-u.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
2021 Year 06 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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2024 Year 06 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
2021 Year 05 Month 31 Day
Last modified on
2021 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050696

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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