- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408809
The Impact of Orthopaedic Smoking Cessation Education on Cigarette Abstinence Self-Efficacy: A Randomized Controlled Trial
June 11, 2017 updated by: Nkemakolam Egekeze, University of Missouri, Kansas City
The investigators of this study aim to evaluate the impact of a new orthopaedic related smoking cessation discussion on smoking behavior.
Considering the high prevalence of patients who smoke and receive orthopaedic management, we are interested in determining whether an orthopaedic smoking cessation discussion impacts smoking abstinence self-efficacy over time compared to a general smoking cessation discussion.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Daily cigarette smokers (5 cigarettes or more a day for past year), 18 years of age or older, new orthopaedic management, native English speaker
Exclusion Criteria:
- Patients unable to provide consent, suffer an impairment (mental, psychiatric, hearing or sight), alcohol and illicit drug abusers, homeless, presently managed with a smoking cessation medication or counseling, living with a cigarette smoker, user of other tobacco products
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
|
This group receives the 5 A's of smoking cessation counseling incorporating how cigarette smoking negatively impacts general health (cancer, MI). 10 minutes in length.
|
Active Comparator: Intervention
|
The participants in this group receive a discussion including the 5 A's of smoking cessation counseling incorporating an orthopaedic related smoking cessation discussion about the effects of smoking cigarettes on the musculoskeletal system.
10 minutes in length.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SASEQ
Time Frame: 5 minutes
|
Smoking abstinence Self-Efficacy Questionnaire
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Knowledge and Motivation to Quit
Time Frame: less than 20 minutes
|
Knowledge and Motivation assessments
|
less than 20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nkem Egekeze, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY
- Study Director: Akin Cil, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY
- Study Director: Karen Williams, PhD, UMKC DEPT OF BIOINFORMATICS
- Study Director: James Bogener, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY
- Study Director: Mark Bernhardt, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY
- Study Director: Jonathan Dubin, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
March 31, 2015
First Submitted That Met QC Criteria
April 2, 2015
First Posted (Estimate)
April 3, 2015
Study Record Updates
Last Update Posted (Actual)
June 14, 2017
Last Update Submitted That Met QC Criteria
June 11, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 15-247
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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