CClinicalTrials.gg
Status unknownNCT00679861PRO GPUpdated May 19, 2008

Smoking Interventions in General Medical Practices

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

The sponsor has not verified this record recently (last verified May 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
3,215
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Tobacco Smoking
  • Nicotine Dependence

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Keywords

  • primary medical care
  • computer expert system
  • motivational interviewing
  • health behavior change counselling
  • stages of change
03

In context

Tobacco Use Disorder

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.

Browse Tobacco Use Disorder studies →

Lead sponsor

University Medicine Greifswald is the lead sponsor of 149 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Practices with regular office hours
  • Practices predominantly providing primary medical care for adults
  • Patients with age 18 and older
  • Patients with sufficient German language and cognitive capabilities to complete assessment
  • Patients smoking within the preceding six month

Exclusion criteria

Exclusion Criteria:

  • Practices planing closure within the next 12 months
  • Practices opening less than 12 months ago
05

Study design

Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
3,215 participants (estimated)

Study arms

  • Experimental
    3

    A practitioner delivered counselling and an expert system intervention is implemented in practices allocated to this arm

    Behavioral: Counselling Intervention · Behavioral: Expert-system intervention

  • Experimental
    1

    A practitioner delivered counselling intervention was implemented in practices allocated to this arm

    Behavioral: Counselling Intervention

  • Experimental
    2

    A computer expert system intervention was implemented in practices allocated to this arm

    Behavioral: Expert-system intervention

Interventions

  • BehavioralCounselling 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

  • BehavioralExpert-system intervention

    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.

06

What researchers measure

Primary outcomes

  1. Number of treated Patients by practice within study period

    Time frame: 7 months

  2. Point prevalence smoking abstinence of treated patients

    Time frame: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 months follow-up assessment

Secondary outcomes

  1. Participation rate of practices

    Time frame: within recruitment phase

  2. Quit and cut down attempts of patients

    Time frame: 12 months

  3. number of cigarettes smoked per day

    Time frame: 4 weeks preceeding follow-up

  4. Stages of change progress

    Time frame: at 12 month follow-up compared to baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00679861
Lead sponsor
University Medicine Greifswald
Collaborators
German Federal Ministry of Education and Research, German Research Foundation
First posted
May 19, 2008
Start date
Oct 2004
Primary completion
Aug 2008 (estimated)
Completion
Jun 2009 (estimated)
Last update
May 19, 2008

Study contacts

Christian Meyer, Dr.
principal investigator · University of Greifswald
Ulrich John, Prof. Dr.
study director · University of Greifswald

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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