NCT05461066

Brief Summary

The study was a non-randomized controlled trial of 12-months' follow-up with 182 Spanish community pharmacists. Intervention community pharmacists received the CESAR training to improve their smoking cessation services, consisting of an initial interview and follow-up visits to identify obstacles and reinforce behaviours. The control group received the usual care. Data were self-reported and collected in a computerized health registration system. Outcomes were smoking cessation and quality of life (EuroQOL-5D) collected at baseline, 6 months', and 12 months' follow-up. Cost data were collected for the study period and included direct health costs, sick leave, and intervention costs. Smoking cessation was analysed through logistic regression models. Generalized linear models were carried out for quality-adjusted life year costs. Incremental cost-effectiveness ratios (ICERs) and cost-utility ratios (RCUI) were calculated. Sensitivity analyses were performed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

5 years

First QC Date

July 7, 2022

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Smoking cessation

    Dichotomicus variable (yes/no)

    Before/after the intervention (1 year)

  • Quality of Life (EuroQOL-5D)

    Measured with EuroQOL-5D

    1 year

  • Cost-effectiveness

    In cost-effectiveness, the deterministic Incremental Cost Effectiveness Ratio (ICER) is the coefficient resulting from dividing the difference between groups in costs by the difference in probability between groups that an additional patient will cease their smoking history.

    1 year

  • Cost-utility

    For the cost-utility, the Deterministic Incremental Cost-Utility Ratio (ICUR) is the coefficient resulting from dividing the difference between groups in costs by the difference between groups in quality-adjusted life years.

    1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Smoking cessation intervention in community pharmacies

Behavioral: CESAR training

Control

ACTIVE COMPARATOR

Usual care of smoking cessation in community pharmacies

Behavioral: CESAR training

Interventions

CESAR trainingBEHAVIORAL

Intervention community pharmacists received the CESAR training to improve their smoking cessation services, consisting of an initial interview and follow-up visits to identify obstacles and reinforce behaviours.

ControlIntervention

Eligibility Criteria

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

You may qualify if:

  • smoker over 18 years old
  • consent to participate
  • presence at the community pharmacy for one of three reasons (a) a medical prescription for a treatment to stop smoking, (b) a consultation about how to stop smoking, (c) asking if he/she smokes when he/she consults for associated symptoms or harm.

You may not qualify if:

  • cognitive impairment
  • drug uses
  • pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gomez Martinez JC, Gaztelurrutia Lavesa L, Mendoza Barbero A, Plaza Zamora J, Lage Pinon M, Aguilo Juanola M, Climent Catala M, de Andres Dirube A, Garcia Moreno L, Jaraiz Magarinos I, Moral Ajado M, Sanchez Marcos N. Smoking cessation intervention in the community pharmacy: Cost-effectiveness of a non-randomized cluster-controlled trial at 12-months' follow-up. Res Social Adm Pharm. 2024 Jan;20(1):19-27. doi: 10.1016/j.sapharm.2023.09.003. Epub 2023 Sep 7.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 15, 2022

Study Start

January 1, 2016

Primary Completion

December 31, 2020

Study Completion

July 1, 2021

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.