Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125905
Status:
UNKNOWN
Last Update Posted:
2009-09-30
First Post:
2005-08-01
Brief Title:
ISTAPS A Stepped Primary Care Smoking Cessation Intervention
Sponsor:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Study Overview
Official Title:
Effectiveness of a Stepped Primary Care Smoking Cessation Intervention Based on an Evidence Based Clinical Practice Guideline ISTAPS Project
Status:
UNKNOWN
Status Verified Date:
2003-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary care centers can play a very important role in helping people to stop smoking There is a large body of research on the effectiveness of specific interventions especially addressed to people who want to stop smoking In addition to that there are no studies with a large sample of individuals included that tested the complete range of interventions recommended nowadays for helping people in the different smoking cessation stages of change and with different degrees of physical and psychological dependence especially including motivational interviewing in those not interested in cessation in the very next weeks This study will test a complex intervention that at first classifies smokers in stages and after that treats every smoker according to what stage heshe is in at the moment hisher degree of dependence and hisher own characteristics
Detailed Description:
OBJECTIVES
To evaluate the effectiveness of a stepped smoking cessation intervention based on a transtheoretical model of change that uses the pharmacological and no-pharmacological methods proposed by evidence based Clinical Practice Guidelines for smoking cessation from primary care centers
To assess the health status change in relationship with the smoking cessation process
DESIGN Cluster randomized clinical trial
Unit of Randomization Care basic unit family physician or nurse that cares for the same group of patients Intention to treat analysis
PARTICIPANTS 2911 smokers ages 14-75 years consulting for any reason to primary care centers
INTERVENTION 6-month implementation of recommendations of a Clinical Practice Guideline that includes motivational consulting for smokers at the precontemplation - contemplation stage brief intervention for smokers in preparation-action who do not want help intensive intervention with pharmacotherapies for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage
CONTROL Usual care
MEASUREMENT Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less Point prevalence at the end of intervention 1 and 2 years after the beginning of intervention Continuous abstinence rate for 1 year Change of stage in the smoking cessation process Health status measured by SF-36
To evaluate the effectiveness of a stepped smoking cessation intervention based on a transtheoretical model of change that uses the pharmacological and no-pharmacological methods proposed by evidence based Clinical Practice Guidelines for smoking cessation from primary care centers
To assess the health status change in relationship with the smoking cessation process
DESIGN Cluster randomized clinical trial
Unit of Randomization Care basic unit family physician or nurse that cares for the same group of patients Intention to treat analysis
PARTICIPANTS 2911 smokers ages 14-75 years consulting for any reason to primary care centers
INTERVENTION 6-month implementation of recommendations of a Clinical Practice Guideline that includes motivational consulting for smokers at the precontemplation - contemplation stage brief intervention for smokers in preparation-action who do not want help intensive intervention with pharmacotherapies for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage
CONTROL Usual care
MEASUREMENT Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less Point prevalence at the end of intervention 1 and 2 years after the beginning of intervention Continuous abstinence rate for 1 year Change of stage in the smoking cessation process Health status measured by SF-36
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| G03170 | None | None | None |
| PI021471 | None | None | None |