Tobacco DependencePhase 4TABATICNCT01494246
Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption
A Phase 4 study testing electronic mail in people with Tobacco Dependence and Cessation of Smoking, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence, Cessation of Smoking
- What is being tested?
- electronic mail
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,064 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2012to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Jordi Gol i Gurina Foundation. Research Unit of Barcelona. Lifestyles Research Group.
Barcelona, Barcelona, 08007
About this study
Official title: Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption (TABATIC). A Randomized Controlled Multicentric Trial
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.
Read the 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.
- Conditions
- Tobacco Dependence, Cessation of Smoking
- Being tested
- electronic mail
- Keywords
- Adult, computer-assisted instruction, electronic mail, program evaluation, smoking cessation/methods, continued abstinence
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic mailOther
Also called e-mail, electronic mail, computer intervention,
Some e-mail will be sent to participants who will be in the intervention group in order to intensify the brief advise received for stop smoking.
| Study group | Role | What they receive |
|---|---|---|
| electronic mail | Experimental | Not described Receives: Other: electronic mail |
| brief advise | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in smoking status and maintenance in smoking cessation
The term used to name long term abstinence over 6 months is continuous abstinence.
Measured: the outcome measure is studied at 6 and 12 months
Secondary outcomes (7)
point prevalence abstinence
In case ok not reaching abstinence, will be measured if a subject has changed of stage in "transtheoretical model of Prochaska and DiClemente".
Measured: the outcome measure is studied at 3, 6 and 12 months
self-reported tobacco consumption
Measured: the outcome measure is studied at 3, 6 and 12 months
self-reported smoking reduction
In case not reaching abstinence
Measured: the outcome measure will be studied at 3, 6 and 12 months
stage of change in Prochaska cycle
Measured: the outcome measure will be studied at 3,6 and 12 months
used time by professionals to achieve patients stop smoking
Measured: the outcome measure will be studied at 3, 6 and 12 months
used time by participants
Measured: the outcome measure will be studied at 3, 6 and 12 months
cost to get smoking help in primary care service
The estimated cost of helping people to leave smoking in regular conditions
Measured: the outcome measure will be studied at 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,064 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network, Public Health Service of Cataluña, Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- José L Ballvé Moreno, MD, Study chair, Institut Català de la SalutMarc Casajuana, Economist, Study chair, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaLourdes Clemente, MD, Study chair, Servicio Aragones De SaludLaura Díaz Gete, MD, Principal investigator, Institut Català de la SalutElena M Briones Carrió, Statistician, Study chair, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaMireia Fàbregas Escurriola, MD, Study chair, Institut Català de la SalutElisa Puigdomènech Puig, Byologist, Study chair, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaJosé L del Val, MD, Study chair, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494246
- Sponsor's protocol ID
- PI11/00817
- Acronym
- TABATIC
- Status last verified
- Jun 2014
- First submitted
- 30 Nov 2011
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diaz-Gete L, Puigdomenech E, Briones EM, Fabregas-Escurriola M, Fernandez S, Del Val JL, Ballve JL, Casajuana M, Sanchez-Fondevila J, Clemente L, Castano C, Martin-Cantera C; Grupo Estudio TABATIC. Effectiveness of an intensive E-mail based intervention in smoking cessation (TABATIC study): study protocol for a randomized controlled trial. BMC Public Health. 2013 Apr 18;13:364. doi: 10.1186/1471-2458-13-364.
PubMed 23597262
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an E-mail Tracking Intervention Among the Continued Abstinence of Tobacco Consumption (TABATIC). A Randomized Controlled Multicentric Trial
- ClinicalTrials.gov ID
- NCT01494246
- Acronym / sponsor ID
- TABATIC / PI11/00817
- Conditions
- Tobacco Dependence, Cessation of Smoking
- Keywords
- Adult, computer-assisted instruction, electronic mail, program evaluation, smoking cessation/methods, continued abstinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,064 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network, Public Health Service of Cataluña, Carlos III Health Institute
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electronic mail | Experimental | Other: electronic mail |
| brief advise | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic mailAlso: e-mail, electronic mail, computer intervention,Some e-mail will be sent to participants who will be in the intervention group in order to intensify the brief advise received for stop smoking. | Other | electronic mail |
Primary outcome
Change in smoking status and maintenance in smoking cessation
Time frame: the outcome measure is studied at 6 and 12 months
The term used to name long term abstinence over 6 months is continuous abstinence.
7 secondary outcomes
point prevalence abstinence
Time frame: the outcome measure is studied at 3, 6 and 12 months
self-reported tobacco consumption
Time frame: the outcome measure is studied at 3, 6 and 12 months
self-reported smoking reduction
Time frame: the outcome measure will be studied at 3, 6 and 12 months
stage of change in Prochaska cycle
Time frame: the outcome measure will be studied at 3,6 and 12 months
used time by professionals to achieve patients stop smoking
Time frame: the outcome measure will be studied at 3, 6 and 12 months
used time by participants
Time frame: the outcome measure will be studied at 3, 6 and 12 months
cost to get smoking help in primary care service
Time frame: the outcome measure will be studied at 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
- Background: PubMed 23597262Diaz-Gete L, Puigdomenech E, Briones EM, Fabregas-Escurriola M, Fernandez S, Del Val JL, Ballve JL, Casajuana M, Sanchez-Fondevila J, Clemente L, Castano C, Martin-Cantera C; Grupo Estudio TABATIC. Effectiveness of an intensive E-mail based intervention in smoking cessation (TABATIC study): study protocol for a randomized controlled trial. BMC Public Health. 2013 Apr 18;13:364. doi: 10.1186/1471-2458-13-364.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José L Ballvé Moreno, MD study chair
Institut Català de la Salut
Marc Casajuana, Economist study chair
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lourdes Clemente, MD study chair
Servicio Aragones De Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing electronic mail in people with Tobacco Dependence and Cessation of Smoking, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in smoking status and maintenance in smoking cessation (time frame: the outcome measure is studied at 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01494246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2014; AzTrials last refreshed its copy on 30 Oct 2026.