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

Intervention / Treatment

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
Behavioral: General Smoking Cessation Discussion
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
Behavioral: Orthopaedic Related Smoking Cessation Discussion
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.

Sponsor

University of Missouri, Kansas City

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

Keywords

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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