Effectiveness of intensive group and individual interventions against smoking in primary health care settings
| ISRCTN | ISRCTN32323770 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32323770 |
| Secondary identifying numbers | PI03/1648 |
- Submission date
- 11/05/2009
- Registration date
- 17/06/2009
- Last edited
- 02/12/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maria Ramos Monserrat
Scientific
Scientific
Conselleria de Salut i Consum
C/ Cecili Metel 18
Palma
07003
Spain
| Phone | +34 971176891 |
|---|---|
| mramos@dgsanita.caib.es |
Study information
| Study design | Three-arm individually randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Scientific title | Effectiveness of intensive group and individual interventions against smoking in primary health care settings: a three-arm individually randomised controlled trial |
| Study objectives | In primary health care settings, an intensive group intervention against smoking is more effective than an intensive individual intervention. |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2004 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 597 |
| Key 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. |
| Key exclusion criteria | 1. Individuals less than 18 years of age 2. Terminal ilness 3. Certain mental health conditions (dementia and schizophrenia) |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Spain
Study participating centre
Conselleria de Salut i Consum
Palma
07003
Spain
07003
Spain
Sponsor information
Ministry of Health and Consumer Affairs (Spain)
Government
Government
Instituto de Salud Carlos III
C/ Sinesio Delgado 6
Madrid.
28029
Spain
| Website | http://www.isciii.es |
|---|---|
"ROR" |
https://ror.org/00y6q9n79 |
Funders
Funder type
Government
Ministry of Health and Consumer Affairs (Spain) - Health Research Fund
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/11/2005 | Yes | No | ||
| Results article | results | 23/02/2010 | Yes | No |
