UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044380
Receipt number 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 2024/02/01 16:31:48

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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 or person

Institute

School of Pharmacy, Nihon University

Institute

Department

Personal name



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

Terminated

Date of protocol fixation

2020 Year 03 Month 05 Day

Date of IRB

2021 Year 04 Month 12 Day

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

2024 Year 02 Month 01 Day



Link to view the page

Value
https://center6.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