Contact information
Type
Scientific
Primary contact
Dr Maria Ramos Monserrat
ORCID ID
Contact details
Conselleria de Salut i Consum
C/ Cecili Metel 18
Palma
07003
Spain
+34 971176891
mramos@dgsanita.caib.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PI03/1648
Study information
Scientific title
Effectiveness of intensive group and individual interventions against smoking in primary health care settings: a three-arm individually randomised controlled trial
Acronym
Study hypothesis
In primary health care settings, an intensive group intervention against smoking is more effective than an intensive individual intervention.
Ethics approval
1. Balearic Islands Ethical Board approved on the 26th February 2003 (ref: PI031648)
2. Mallorca Primary Health Care Research Board approved on the 27th February 2003 (ref: PI031648)
Study design
Three-arm individually randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Condition
Smoking
Intervention
The participants were randomly allocated to the following three arms:
Arm 1: Intensive group intervention
Arm 2: Intensive individual intervention
Arm 3: Usual minimal intervention
Intensive interventions (both group and individual):
Consisted of counselling, psychological support and standardised follow-up. Pharmacological treatment with nicotine derivatives or bupropion was also offered as an option at the physician's judgment.
Usual minimal intervention:
Brief counselling. Pharmacological treatment was also offered as an option at the physician's judgement.
The total duration of interventions was variable. In individual intensive intervention, the protocol recommended 20 minutes for the first visit and 10 minutes for the following. In group intensive intervention, the protocol recommended around 1 hour for all visits. In practice, more time was devoted, especially in group intervention. In usual minimal intervention, no recommendations were given.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Continued abstinence at 12 months confirmed through CO-oximetry
Secondary outcome measures
1. Self-reported continued abstinence at 12 months
2. Point abstinence at 12 months confirmed through CO-oximetry
3. Point self-reported abstinence at 12 months
Overall trial start date
01/01/2004
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
People (both male and female) who smoked and who were in the preparatory phase in accordance with Prochaska's and Di Clemente's transtheoretical model of health behaviour.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
597
Participant exclusion criteria
1. Individuals less than 18 years of age
2. Terminal ilness
3. Certain mental health conditions (dementia and schizophrenia)
Recruitment start date
01/01/2004
Recruitment end date
01/01/2006
Locations
Countries of recruitment
Spain
Trial participating centre
Conselleria de Salut i Consum
Palma
07003
Spain
Sponsor information
Organisation
Ministry of Health and Consumer Affairs (Spain)
Sponsor details
Instituto de Salud Carlos III
C/ Sinesio Delgado 6
Madrid.
28029
Spain
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Health and Consumer Affairs (Spain) - Health Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. Protocol (Spanish only):
Ramos M, Milán J, Medina D, Puig B, Janer JM y Ripoll J. Efectividad de las intervenciones grupal e individual avanzadas para el abordaje del tabaquismo en atención primaria. Aten Primaria. 2005; 36 (8): 462-5
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20178617
Publication citations
-
Results
Ramos M, Ripoll J, Estrades T, Socias I, Fe A, Duro R, González MJ, Servera M, Effectiveness of intensive group and individual interventions for smoking cessation in primary health care settings: a randomized trial., BMC Public Health, 2010, 10, 89, doi: 10.1186/1471-2458-10-89.