Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs (OMSC in DEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Ottawa Heart Institute
Sponsor:
Information provided by (Responsible Party):
Dr Robert Reid, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01980017
First received: November 1, 2013
Last updated: June 18, 2014
Last verified: June 2014

November 1, 2013
June 18, 2014
July 2013
March 2015   (final data collection date for primary outcome measure)
Self report of not smoking (even a puff) in the last 7 days + CO <10ppm [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
The OMSC intervention will increase carbon monoxide (CO) validated 7-day point prevalence abstinence rates at 6-month follow-up by at least 10% among smokers with diabetes referred to DEPs compared to standard care.
Self report of not smoking (even a puff) in the last 7 days + CO <10ppm [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
The OMSC intervention will increase carbon monoxide (CO) validated 7-day point prevalence abstinence rates at 6-month follow-up by at least 7% among smokers with diabetes referred to DEPs compared to standard care.
Complete list of historical versions of study NCT01980017 on ClinicalTrials.gov Archive Site
Cost-effectiveness of smoking cessation interventions. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
There is clear evidence regarding the cost-effectiveness of smoking cessation interventions, there is a lack of implementation knowledge to inform the design and delivery of these interventions into routine clinical practice. This study considers an intervention that optimizes the effective use of smoking cessation interventions in 'real life' clinical education settings.
Same as current
Not Provided
Not Provided
 
Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs
A Prospective Cluster-Randomized Trial to Implement the Ottawa Model for Smoking Cessation in Diabetes Education Programs.

The incidence of type 2 diabetes mellitus (T2DM) is increasing rapidly. The combination of T2DM and smoking is particularly lethal, as smokers with T2DM are significantly more likely to develop a number of health related complications. Community-based diabetes education programs (DEPs) have been developed to support patient self-care behaviours (e.g. adherence to oral medications, insulin therapy, nutrition management, regular blood glucose monitoring, and physical activity); however, specific assistance for smoking cessation is rarely provided. Our investigative team has developed a knowledge transfer and practice change process to introduce evidence-based interventions for smoking cessation into clinical practice settings. This process is known as the Ottawa Model for Smoking Cessation (OMSC). Investigators believe there is an opportunity to use the OMSC intervention to dramatically enhance the effectiveness of DEPs in addressing smoking cessation among smokers with T2DM, and in so doing, improve quit rates in this high risk population.

The purpose of this project is to evaluate the effectiveness of the Ottawa Model for Smoking Cessation (OMSC) intervention in multiple diabetes education programs (DEPs) in Ontario. A two-level recruitment strategy will be employed. Eighteen DEPs will be recruited, and then a consecutive sample of eligible smoker-patients will be recruited from each DEP over a 6-month recruitment period. Investigators want to test the impact of the OMSC intervention on quit rates among smokers with diabetes and pre-diabetes referred to these programs. Investigators will conduct a matched-pair cluster design trial at 18 DEPs in Ontario. These sites will be matched based on number of annual referrals for diabetes education (≤ 500/year or > 500/year). Within each pair, sites will be allocated randomly to either OMSC intervention or control group. Following randomization, the OMSC program will be implemented at the intervention sites over a 6-month period. Following the implementation period, a consecutive sample of smokers will be recruited from both OMSC intervention and control DEPs over a 6-month recruitment period. It is estimated that this will yield a sample of approximately 445 smokers in each of the OMSC intervention and control groups. The primary outcome will be the biochemically-validated 7-day point prevalence abstinence rate six months after an index visit to the DEP. Secondary outcomes will include: rates of identification and intervention of smokers, and diabetes educators' attitudes, confidence, and perceptions of barriers and facilitators to implementing smoking cessation support as part of routine care.

If proven effective, the OMSC is appropriate for implementation in DEPs across Canada and could have profound impacts on patient and community health.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pre-diabetic
  • Diabetic Type II Mellitus
Behavioral: Ottawa Model for Smoking Cessation
  • No Intervention: Wait-Listed Control Group
    Usual care for smoking cessation
  • Experimental: Ottawa Model for Smoking Cessation
    Ottawa Model for Smoking Cessation
    Intervention: Behavioral: Ottawa Model for Smoking Cessation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
890
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient has been referred to DEP for T2DM diabetes or pre-diabetes.
  • The patient is a current smoker (self-report of daily smoking a minimum of 1 cigarette per day in the 30 days preceding recruitment).
  • The patient is aged between 18 years and 80 years.

Exclusion Criteria:

  • The patient is currently involved in any other smoking cessation intervention.
  • The patient is able to read and understand French or English.
  • The patient is able to and willing to provide informed consent.
Both
18 Years to 80 Years
No
Contact: Amy Geertsma, BSc. 613-761-4488 ageertsma@ottawaheart.ca
Contact: Ashley Armstrong, MA 613-798-5555 ext 19345 aarmstrong@ottawaheart.ca
Canada
 
NCT01980017
20130177-01H
No
Dr Robert Reid, University of Ottawa Heart Institute
University of Ottawa Heart Institute
Not Provided
Principal Investigator: Robert Reid, PhD., MBA University of Ottawa Heart Institute
Study Chair: Andrew Pipe, MD, FRCPC University of Ottawa Heart Institute
Study Chair: Oh Paul, MD, FRCPC Toronto Rehabilitation Institute
Study Chair: Anil Gupta, MD, FRCPC Trillium Heath Centre
Study Chair: Kocourek Jana, MA University of Ottawa Heart Institute
Study Chair: Mullen Kerri-Anne, MSc. University of Ottawa Heart Institute
Study Chair: Aiken Debbie, BScN University of Ottawa Heart Institute
Study Chair: Tulloch Heather, Ph.D., Psych. University of Ottawa Heart Institute
Study Chair: David Arbeau, BA, BTech, RT Horizon Health Network
Study Chair: Malcolm Janine, MD, FRCPC Faculty of Medicine, University of Ottawa
University of Ottawa Heart Institute
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP