Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption

Phase 4

• Conditions: Tobacco Dependence; Cessation of Smoking
• Interventions: Other: electronic mail

• Registration Number: NCT01494246
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Brief Summary

Objectives. To evaluate the effectiveness and cost effectiveness of clinical practice guide based intervention with two face-to-face visits and e-mail tracking compared to brief advice to obtain continued smoking abstinence at 6 and 12 months after intervention.

Methodology. simple randomized controlled multicentric trial. All smokers (N=1064) aged 18 or older that attend by any reason to the primary care center and that have an e-mail account and they checked it at least once a week will be invited to participate. The enrolled participants will be randomly divided into control (N=532) and intervention group (N=532). An intensive intervention, based on the recommendations of the clinical practice guides, that will include six contacts (2 face-to-face and 4 by e-mail) will be applied to the intervention group. Control group will receive brief advice.

The main dependent variable will be continued abstinence of tobacco consumption at six and twelve months after the beginning of the intervention which will be validated by and a carbon monoxide breathe analysis measured by a cooximeter in standard conditions. Secondary variables will include: stage change on the quitting smoking process and evaluation of the effectiveness on the reduction of the number of smoked cigarettes at six and twelve months after intervention. A descriptive analysis of all variables will be done. A multivariate analysis will be undertaken to assess differences among intervention and control group; logistic regression for dichotomic variables and lineal regression for continuous variables.

Detailed Description

In preliminary phase is planned to carry out 2 descriptive sub-studies: a qualitative one, which will reflect the views of patients and physicians regarding the use of email as a smoking cessation intervention, and another smoker's profile in relation to Information and Communication Technologies (ICT), which collects information on the actual use of them in smokers. The result of both will help to release data on the type of participants who would be involved in the clinical trial.

Study Timeline

• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-16
• Study Start: 2012-12
• Primary Completion: 2013-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-19
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1064

Inclusion Criteria

• Smokers over 18 years old with an e-mail account who use frequently. (Smoker is an individual who smokes any amount of tobacco, whatever this amount it is.
• E-mail regular user is the one who uses it as a way of communication at least once per week)

Exclusion Criteria

• Not regular e-mail users,
• patients who have diseases that advise not to stop smoking:
• Terminal diseases
• Serious psychiatric disorders
• Active addiction to other psychoactive drugs
• Patients in smoking cessation process
• whatever the cause that does not allow to understand goals and methodology of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electronic mail	electronic mail	-

Primary Outcome Measures

Name	Time	Method
Change in smoking status and maintenance in smoking cessation	the outcome measure is studied at 6 and 12 months	The term used to name long term abstinence over 6 months is continuous abstinence.

Secondary Outcome Measures

Name	Time	Method
point prevalence abstinence	the outcome measure is studied at 3, 6 and 12 months	In case ok not reaching abstinence, will be measured if a subject has changed of stage in "transtheoretical model of Prochaska and DiClemente".
self-reported tobacco consumption	the outcome measure is studied at 3, 6 and 12 months
self-reported smoking reduction	the outcome measure will be studied at 3, 6 and 12 months	In case not reaching abstinence
cost to get smoking help in primary care service	the outcome measure will be studied at 3, 6 and 12 months	The estimated cost of helping people to leave smoking in regular conditions
stage of change in Prochaska cycle	the outcome measure will be studied at 3,6 and 12 months
used time by professionals to achieve patients stop smoking	the outcome measure will be studied at 3, 6 and 12 months
used time by participants	the outcome measure will be studied at 3, 6 and 12 months

Trial Locations

Locations (1)

Jordi Gol i Gurina Foundation. Research Unit of Barcelona. Lifestyles Research Group.; 🇪🇸 Barcelona, Spain