A Phase 2 interventional study of Counselling Intervention and Expert-system intervention in Tobacco Smoking and Nicotine Dependence, sponsored by University Medicine Greifswald. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-05-19.
Sponsored by University Medicine Greifswald · Phase 2, Interventional, and Health services research
Primary care physicians can play an important role in reducing tobacco smoking in the population. The general practice is a suitable setting for implementing proactive smoking interventions, because a large proportion of the population can be regularly reached in a favorable psychological state. Further, a trustful interpersonal relationship between the practitioners and their patients is supposed to increase the susceptibility to preventive measures. However, currently general practitioners are not capitalizing this advantage although evidence based treatments are available, which are effective and cost-effective. Outreach programs combining educational and practice-based measures have been found to be effective in engaging practitioners in screening and in giving advice. Computer expert-system and brief counseling interventions, which are based on the Transtheo-retical Model of behavior change (TTM), are promising approaches for the entire population of practitioners and smoking patients. For large scale implementation, data are needed about the degree of integration in every day routine clinical practice that could be achieved by implementing such interventions. Objectives: Evaluating different strategies for the implementation of proactive smoking interventions in general practices. Methods: In a randomized controlled trial, 150 randomly selected general practices of a defined German region will be included. The procedure comprises the implementation of 1) an on-site computer expert-system intervention, 2) a counseling intervention provided by the practitioner, or 3) the computer expert-system plus the counseling intervention. During an implementation phase of one month, two on site training sessions and support by phone will be provided. Routine use of the interventions will be monitored for the following 6 months. Main outcome measures are the number and rate of identified and treated smokers. A follow-up assessment will be realized 12 months after practice attendance to determine the smoking status of the treated smokers.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's planned enrollment of 3,215 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
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A practitioner delivered counselling and an expert system intervention is implemented in practices allocated to this arm
Behavioral: Counselling Intervention · Behavioral: Expert-system intervention
A practitioner delivered counselling intervention was implemented in practices allocated to this arm
Behavioral: Counselling Intervention
A computer expert system intervention was implemented in practices allocated to this arm
Behavioral: Expert-system intervention
A personal counselling by the residing practitioner of up to 10 minutes. A follow-up counselling is included for the next regular patient consultation
Counselling letter of three to four pages will be generated by an expert-system base on the assessment of the patient. A second and third letter will be generated at follow-up consultations.
Number of treated Patients by practice within study period
Time frame: 7 months
Point prevalence smoking abstinence of treated patients
Time frame: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 months follow-up assessment
Participation rate of practices
Time frame: within recruitment phase
Quit and cut down attempts of patients
Time frame: 12 months
number of cigarettes smoked per day
Time frame: 4 weeks preceeding follow-up
Stages of change progress
Time frame: at 12 month follow-up compared to baseline
No study locations are listed for this record.
This study is status unknown, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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University Medicine Greifswald