NCT00294905

Brief Summary

A controlled study demonstrated that a smoking cessation protocol in routine primary care, specifically targeted at patients with COPD (SMOCC), doubled the quit rates. The protocol was tested under optimal trial conditions, but it is unclear if a large-scale implementation strategy is (cost-)effective. Therefore the present study investigates a large scale implementation strategy in a 2-armed community intervention trial. The research question is how (cost-)effective this implementation strategy is compared to usual implementation procedures.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 23, 2010

Status Verified

February 1, 2007

First QC Date

February 21, 2006

Last Update Submit

September 22, 2010

Conditions

COPD

Keywords

COPDsmoking cessationimplementationpatient counselinggeneral practice

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measures will be biochemically validated smoking abstinence at 12 and 18 months

Secondary Outcomes (1)

  • Secondary outcome measures will be counseling contacts and counseling behaviour of professionals and cessation attempts of patients

Interventions

Implementation of a combined smoking cessation strategyBEHAVIORAL

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD
  • Smoking
  • Age 40 years or over

You may not qualify if:

  • Under control of lung specialist
  • Not Dutch-speaking
  • Serious physical of psychiatric comorbidity
  • Under 40 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre, Centre for Quality of Care Research (WOK)

117 Kwazo, Postbus 9101, 6500 Hb, Nijmegen, Netherlands

Location

Related Publications (1)

  • Hilberink SR, Jacobs JE, Bottema BJ, de Vries H, Grol RP. Smoking cessation in patients with COPD in daily general practice (SMOCC): six months' results. Prev Med. 2005 Nov-Dec;41(5-6):822-7. doi: 10.1016/j.ypmed.2005.08.003. Epub 2005 Oct 3.

    PMID: 16203030BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSmoking Cessation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Study Officials

  • R. Grol, PhD

    Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 22, 2006

Study Start

March 1, 2006

Study Completion

June 1, 2008

Last Updated

September 23, 2010

Record last verified: 2007-02

Locations

NL(1)