NCT02554071

Brief Summary

A single arm pilot study conducted to assess the feasibility of having Manitoba Pharmacists provide support (product and cognitive) to low-income (receiving social assistance) smokers wishing to quit smoking.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

10 months

First QC Date

September 16, 2015

Last Update Submit

September 16, 2015

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Smoking Cessation Assessment

    Self-reported Smoking Cessation on Standardized Form

    6 months

Secondary Outcomes (4)

  • Smoking Cessation Assessment

    1 month

  • Smoking Cessation Assessment

    3 months

  • Smoking Cessation Product

    3 months

  • Quit Diary

    6 months

Other Outcomes (2)

  • Cigarettes Smoked

    day 0, 1 month, 3 months and 6 months

  • Pharmacist Time

    6 months

Study Arms (1)

Pharmacist - Smoking Cessation Support'

EXPERIMENTAL

Active Comparator Arm Receive smoking assessment Initial Smoking Cessation Counselling Smoking Cessation Prescription/Non-Prescription Product as required Follow-up Counselling

Other: Pharmacist - Smoking Cessation Support

Interventions

Pharmacist - Smoking Cessation SupportOTHER

Intervention mirrors clinical practice with smoking cessation counselling -- patients receive smoking cessation product at no cost and pharmacists are paid flat fee for providing counselling

Pharmacist - Smoking Cessation Support'

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • smoker
  • \>= 18 years
  • receiving Manitoba Employment and Income Assistance as of January 1st 2015
  • Stated desire to quit smoking
  • Signed Consent with associated agreement to participate in evaluation and follow-up

You may not qualify if:

  • \< 18
  • Not on Income Assistance
  • Current non-smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Pharmacy, University of Manitoba

Winnipeg, Manitoba, R6M 1L4, Canada

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Shawn C Bugden, PharmD

    College of Pharmacy, University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 18, 2015

Study Start

January 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

CA(1)