Cigarette SmokingNCT02408809
The Impact of Orthopaedic Smoking Cessation Education on Cigarette Abstinence Self-Efficacy: A Randomized Controlled Trial
A study testing General Smoking Cessation Discussion and Orthopaedic Related Smoking Cessation Discussion in people with Cigarette Smoking, run by University of Missouri, Kansas City.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- General Smoking Cessation Discussion and Orthopaedic Related Smoking Cessation Discussion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Daily cigarette smokers (5 cigarettes or more a day for past year), 18 years of age or older, new orthopaedic management, native English speaker
Who cannot join
- 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
About this study
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.
- Conditions
- Cigarette Smoking
- Being tested
- General Smoking Cessation Discussion, Orthopaedic Related Smoking Cessation Discussion
- Keywords
- Orthopaedic Smoking Cessation Discussion, Smoking Cessation, Randomized Controlled Trial
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Smoking Cessation DiscussionBehavioural
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.
Orthopaedic Related Smoking Cessation DiscussionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Behavioral: General Smoking Cessation Discussion |
| Intervention | Active comparator | Not described Receives: Behavioral: Orthopaedic Related Smoking Cessation Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
SASEQ
Smoking abstinence Self-Efficacy Questionnaire
Measured: 5 minutes
Secondary outcomes (1)
Patient Knowledge and Motivation to Quit
Knowledge and Motivation assessments
Measured: less than 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nkemakolam Egekeze, University of Missouri, Kansas City
- Investigators
- Nkem Egekeze, MD, Principal investigator, UMKC DEPT OF ORTHOPAEDIC SURGERYAkin Cil, MD, Study director, UMKC DEPT OF ORTHOPAEDIC SURGERYKaren Williams, PhD, Study director, UMKC DEPT OF BIOINFORMATICSJames Bogener, MD, Study director, UMKC DEPT OF ORTHOPAEDIC SURGERYMark Bernhardt, MD, Study director, UMKC DEPT OF ORTHOPAEDIC SURGERYJonathan Dubin, MD, Study director, UMKC DEPT OF ORTHOPAEDIC SURGERY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408809
- Sponsor's protocol ID
- 15-247
- Status last verified
- Jun 2017
- First submitted
- 31 Mar 2015
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Orthopaedic Smoking Cessation Education on Cigarette Abstinence Self-Efficacy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02408809
- Acronym / sponsor ID
- 15-247
- Conditions
- Cigarette Smoking
- Keywords
- Orthopaedic Smoking Cessation Discussion, Smoking Cessation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: General Smoking Cessation Discussion |
| Intervention | Active comparator | Behavioral: Orthopaedic Related Smoking Cessation Discussion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Daily cigarette smokers (5 cigarettes or more a day for past year), 18 years of age or older, new orthopaedic management, native English speaker
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Smoking Cessation DiscussionThis group receives the 5 A's of smoking cessation counseling incorporating how cigarette smoking negatively impacts general health (cancer, MI). 10 minutes in length. | Behavioural | Control |
| Orthopaedic Related Smoking Cessation DiscussionThe 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. | Behavioural | Intervention |
Primary outcome
SASEQ
Time frame: 5 minutes
Smoking abstinence Self-Efficacy Questionnaire
1 secondary outcome
Patient Knowledge and Motivation to Quit
Time frame: less than 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nkem Egekeze, MD principal investigator
UMKC DEPT OF ORTHOPAEDIC SURGERY
Akin Cil, MD study director
UMKC DEPT OF ORTHOPAEDIC SURGERY
Karen Williams, PhD study director
UMKC DEPT OF BIOINFORMATICS
Questions about this trial
What is this clinical trial studying?
A study testing General Smoking Cessation Discussion and Orthopaedic Related Smoking Cessation Discussion in people with Cigarette Smoking, run by University of Missouri, Kansas City.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SASEQ (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.