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

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ClinicalTrials.gov Identifier: NCT01980017
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Robert Reid, Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE November 1, 2013
First Posted Date  ICMJE November 8, 2013
Last Update Posted Date December 11, 2017
Study Start Date  ICMJE July 2013
Actual Primary Completion Date October 18, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
Self report of not smoking (even a puff) in the last 7 days + CO <10ppm [ Time Frame: 26 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
Self report of not smoking (even a puff) in the last 7 days + CO <10ppm [ Time Frame: 26 weeks ]
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.
Change History Complete list of historical versions of study NCT01980017 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
Cost-effectiveness of smoking cessation interventions. [ Time Frame: 26 weeks ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Ottawa Model for Smoking Cessation in Diabetes Education Programs
Official Title  ICMJE A Prospective Cluster-Randomized Trial to Implement the Ottawa Model for Smoking Cessation in Diabetes Education Programs.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Pre-diabetic
  • Diabetic Type II Mellitus
Intervention  ICMJE Behavioral: Ottawa Model for Smoking Cessation
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2017)
313
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2013)
2520
Actual Study Completion Date  ICMJE March 15, 2017
Actual Primary Completion Date October 18, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01980017
Other Study ID Numbers  ICMJE 20130177-01H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Robert Reid, Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Reid, PhD., MBA Ottawa Heart Institute Research Corporation
Study Chair: Andrew Pipe, MD, FRCPC Ottawa Heart Institute Research Corporation
Study Chair: Oh Paul, MD, FRCPC Toronto Rehabilitation Institute
Study Chair: Anil Gupta, MD, FRCPC Trillium Heath Centre
Study Chair: Kocourek Jana, MA Ottawa Heart Institute Research Corporation
Study Chair: Mullen Kerri-Anne, MSc. Ottawa Heart Institute Research Corporation
Study Chair: Aiken Debbie, BScN Ottawa Heart Institute Research Corporation
Study Chair: Tulloch Heather, Ph.D., Psych. Ottawa Heart Institute Research Corporation
Study Chair: David Arbeau, BA, BTech, RT Horizon Health Network
Study Chair: Malcolm Janine, MD, FRCPC Faculty of Medicine, University of Ottawa
PRS Account Ottawa Heart Institute Research Corporation
Verification Date December 2017

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