SmokingNCT05594199
Feasibility of a Virtual Smoking Cessation Program
A study testing Virtual Smoking Cessation Program in people with Smoking and Smoking Cessation, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The goal of this pilot study of a clinical trial is to learn about the acceptability and feasibility of a virtual smoking cessation program in both the perioperative and fracture clinic settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation, Smoking Reduction
- What is being tested?
- Virtual Smoking Cessation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2022to 11 Sep 2024
- 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
- 18+ years of age
- Daily or non-daily smoker
- Self-reported smokers who have smoked cigarettes within the past 30 days
- Must be a patient at Toronto Western Hospital or Women's College Hospital who is:
- Scheduled for an elective surgical procedure that will occur at least 48 hours after recruitment OR
- Visiting the fracture clinic (UHN) within and including 14 days from the initial date of injury or operation
- Must have a working e-mail address
Who cannot join
- Patients who have already quit smoking for more than 30 days,
- Patients who cannot read and understand English,
- Patients who have any form of cognitive impairment,
- Patients who do not have a telephone (for follow-up).
- Currently on pharmacological therapy for smoking cessation
- Drug or alcohol abuse or dependence within the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation Of A Virtual Smoking Cessation Program - A Pilot Study
The goal of this pilot study of a clinical trial is to learn about the acceptability and feasibility of a virtual smoking cessation program in both the perioperative and fracture clinic settings. The main questions this study aims to answer are:
- The number of people that participate in the virtual smoking cessation program
- The acceptability of the number, length, content, and delivery of the email messages provided by the program.
Read more
Participants will be asked to subscribe to our virtual intervention which will include:
- A smoking cessation e-learning module component to provide education on the risks of smoking in the surgical or fracture clinic setting, and
- An emailing program component that will provide tailored email messages over a 30-45 day period depending on a patient's Fagerstrom test for nicotine dependence score and motivation to quit smoking.
Researchers will also compare the virtual smoking cessation program to standard care to see if there are any differences shown between both groups in the Fagerstrom test for nicotine dependence scores, number of cigarettes smoked, number of quit attempts, complication rates, and re-admission rates at the 7 day and 30 day time points.
Read the detailed description
Smoking is the most preventable cause of disease and premature death in Canada. In this pilot study our aim is to determine whether a virtual perioperative program, using automated emails, for smoking cessation is feasible and acceptable for increasing abstinence from smoking, compared to the usual care in patients undergoing surgery or with an acute traumatic fracture. Patients that present to the preoperative clinic or fracture clinic will be recruited for this trial. This feasibility study will be followed by the proposed randomized control trial to identify whether our planned study procedures are acceptable to surgical patients.
Both components of the virtual smoking cessation program (Smoking cessation e-learning modules and Virtual Program Evaluation) will be more personalized to the patient as the patient's nicotine dependence will determine the tailored information that will be provided in the e-learning module and the email messages. Study procedures and components of the virtual smoking cessation program will be modified for clinical use and future research based on the feedback from this pilot study.
- Conditions
- Smoking, Smoking Cessation, Smoking Reduction, Perioperative/Postoperative Complications, Fractures, Bone
- Being tested
- Virtual Smoking Cessation Program
- Keywords
- Smoking, Smoking Cessation, Electronic Mail, Virtual Program, Fracture, Surgery, Perioperative
- Medical subject headings
- Smoking, Smoking Cessation, Smoking Reduction, Postoperative Complications, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Smoking Cessation ProgramBehavioural
This program consists of an e-learning smoking cessation education module and a tailored email messaging program.
The e-learning module addresses the potential health benefits to quitting smoking regarding surgery or recovering from a fracture. In addition, it provides information on getting support through the process of quitting smoking based on the individual's level of smoking dependence.
Email frequency and content will vary based on the participant's score and level of motivation. Information will include the risks associated with smoking before surgery or how quitting smoking can improve recovery from a fracture injury. Additional information includes the benefits of quitting smoking and developing coping strategies during a quit attempt. Motivational emails and references to free resources for additional smoking cessation support will also be provided.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: Virtual Group | Experimental | The intervention will involve participating in the study's virtual smoking cessation program. This program consists of 2 components: an e-learning module and a tailored email messaging program based on the participant's motivation to quit smoking and their Fagerstrom test for nicotine dependence score. Receives: Behavioral: Virtual Smoking Cessation Program |
| Control Arm: Standard Care | No intervention | This arm will receive standard care which may or may not include brief advice to quit smoking from any of the healthcare providers. Providing smoking cessation intervention is not mandatory in standard care and may not be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial feasibility - Recruitment
Feasibility as assessed by recruitment rate. This will be assessed as the proportion of participants who agree to participate compared to the number of patients who had met the inclusion/exclusion criteria and were approached to participate in the study.
The demographics of those who declined to participate or dropped out of the virtual program will be assessed for trends within the population who do not wish to participate in the virtual smoking cessation program
Measured: Surgery: 30 days after surgery; Fracture Clinic: 30 days
Trial feasibility - Acceptability of the email message program component
Patients will be asked to evaluate the email program and messages provided during their participation in the virtual program through a questionnaire that will evaluate the frequency, length, content, delivery, and duration of the email message component using a 5-point Likert scale.
Measured: Surgery: 30 Days after surgery; Fracture Clinic: 30 days after study recruitment
Trial feasibility - Acceptability of e-learning module program component
Patients will be asked to evaluate the e-learning module once they completed it. A survey will be administered to evaluate the content and comprehension of the e-learning module using a 5-point Likert scale.
Measured: Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment
Trial feasibility - EPIC patient portal usage
The feasibility of delivering this virtual program through the patient portal will be assessed by the proportion of study participants who have self-reported patient portal use compared to the total number of study participants.
Measured: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
Trial feasibility - Retention
Feasibility as assessed by the retention rates. This will be defined as the proportion of program participants completing the study at the final follow-up compared to the participants enrolled.
Reasons for withdrawal will also be recorded to assess any trends that occur among participants who drop out.
Measured: Surgery: 30 days after surgery; Fracture Clinic: 30 days
Secondary outcomes (8)
Module Education
The effectiveness of the virtual program's e-learning module component will be assessed by a survey that will evaluate the patient's understanding of the risks of smoking before/after surgery and while recovering from a fracture using a 5-point Likert scale.
Measured: At time of recruitment, and after module completion (Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment)
Cigarettes smoked
The number of cigarettes smoked per day.
Measured: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
Quit attempts
The number of quit attempts made since study recruitment.
A quit attempt will be defined by a patient making a serious, conscious attempt to completely abstain from cigarette smoking and has abstained from smoking for at least 24 hours.
Measured: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
Nicotine Dependence
Nicotine dependence will be assessed using the Fagerström test for nicotine dependence, which is a standard instrument for assessing the intensity of physical addiction to nicotine.
Measured: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
Stage of change
Stage of Change will be assessed using Prochaska and DiClemente's Stages of Change Model, a transtheoretical model of change that proposes a series of stages through which smokers move as they successfully change their smoking habit.
Measured: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
Self or assisted quit attempt
Participants will be asked to report whether they are currently going through a self-quit attempt or a quit attempt assisted by a health care professional
Measured: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
Complications/Adverse Events
Complications/adverse events regarding the patient's surgery or recovery from fracture will be obtained from the patient's electronic health record.
Measured: Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment
Readmission
The number of readmissions to the hospital will be obtained from the patient's electronic health record.
Measured: Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Dec 2022
- Primary completion11 Aug 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Wong, University Health Network, Toronto
- Investigators
- Jean Wong, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594199
- Sponsor's protocol ID
- 22-5475
- Status last verified
- Mar 2025
- First submitted
- 21 Oct 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Graham AL, Carpenter KM, Cha S, Cole S, Jacobs MA, Raskob M, Cole-Lewis H. Systematic review and meta-analysis of Internet interventions for smoking cessation among adults. Subst Abuse Rehabil. 2016 May 18;7:55-69. doi: 10.2147/SAR.S101660. eCollection 2016.
PubMed 27274333Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
PubMed 1932883Andersen T, Christensen FB, Laursen M, Hoy K, Hansen ES, Bunger C. Smoking as a predictor of negative outcome in lumbar spinal fusion. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2623-8. doi: 10.1097/00007632-200112010-00018.
PubMed 11725245Mills E, Eyawo O, Lockhart I, Kelly S, Wu P, Ebbert JO. Smoking cessation reduces postoperative complications: a systematic review and meta-analysis. Am J Med. 2011 Feb;124(2):144-154.e8. doi: 10.1016/j.amjmed.2010.09.013.
PubMed 21295194Myers K, Hajek P, Hinds C, McRobbie H. Stopping smoking shortly before surgery and postoperative complications: a systematic review and meta-analysis. Arch Intern Med. 2011 Jun 13;171(11):983-9. doi: 10.1001/archinternmed.2011.97. Epub 2011 Mar 14.
PubMed 21403009
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation Of A Virtual Smoking Cessation Program - A Pilot Study
- ClinicalTrials.gov ID
- NCT05594199
- Acronym / sponsor ID
- 22-5475
- Conditions
- Smoking, Smoking Cessation, Smoking Reduction, Perioperative/Postoperative Complications, Fractures, Bone
- Keywords
- Smoking, Smoking Cessation, Electronic Mail, Virtual Program, Fracture, Surgery, Perioperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 11 Aug 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 26 Oct 2022 (actual)
- 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 goal of this pilot study of a clinical trial is to learn about the acceptability and feasibility of a virtual smoking cessation program in both the perioperative and fracture clinic settings. The main questions this study aims to answer are:
- The number of people that participate in the virtual smoking cessation program
- The acceptability of the number, length, content, and delivery of the email messages provided by the program.
Participants will be asked to subscribe to our virtual intervention which will include:
- A smoking cessation e-learning module component to provide education on the risks of smoking in the surgical or fracture clinic setting, and
- An emailing program component that will provide tailored email messages over a 30-45 day period depending on a patient's Fagerstrom test for nicotine dependence score and motivation to quit smoking.
Researchers will also compare the virtual smoking cessation program to standard care to see if there are any differences shown between both groups in the Fagerstrom test for nicotine dependence scores, number of cigarettes smoked, number of quit attempts, complication rates, and re-admission rates at the 7 day and 30 day time points.
Detailed description
Smoking is the most preventable cause of disease and premature death in Canada. In this pilot study our aim is to determine whether a virtual perioperative program, using automated emails, for smoking cessation is feasible and acceptable for increasing abstinence from smoking, compared to the usual care in patients undergoing surgery or with an acute traumatic fracture. Patients that present to the preoperative clinic or fracture clinic will be recruited for this trial. This feasibility study will be followed by the proposed randomized control trial to identify whether our planned study procedures are acceptable to surgical patients.
Both components of the virtual smoking cessation program (Smoking cessation e-learning modules and Virtual Program Evaluation) will be more personalized to the patient as the patient's nicotine dependence will determine the tailored information that will be provided in the e-learning module and the email messages. Study procedures and components of the virtual smoking cessation program will be modified for clinical use and future research based on the feedback from this pilot study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: Virtual Group | Experimental | Behavioral: Virtual Smoking Cessation ProgramThe intervention will involve participating in the study's virtual smoking cessation program. This program consists of 2 components: an e-learning module and a tailored email messaging program based on the participant's motivation to quit smoking and their Fagerstrom test for nicotine dependence score. |
| Control Arm: Standard Care | No intervention | –This arm will receive standard care which may or may not include brief advice to quit smoking from any of the healthcare providers. Providing smoking cessation intervention is not mandatory in standard care and may not be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18+ years of age
- Daily or non-daily smoker
- Self-reported smokers who have smoked cigarettes within the past 30 days
- Must be a patient at Toronto Western Hospital or Women's College Hospital who is:
- Must have a working e-mail address
Key exclusion criteria (6 listed)
- Patients who have already quit smoking for more than 30 days,
- Patients who cannot read and understand English,
- Patients who have any form of cognitive impairment,
- Patients who do not have a telephone (for follow-up).
- Currently on pharmacological therapy for smoking cessation
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 |
|---|---|---|
| Virtual Smoking Cessation ProgramThis program consists of an e-learning smoking cessation education module and a tailored email messaging program. The e-learning module addresses the potential health benefits to quitting smoking regarding surgery or recovering from a fracture. In addition, it provides information on getting support through the process of quitting smoking based on the individual's level of smoking dependence. Email frequency and content will vary based on the participant's score and level of motivation. Information will include the risks associated with smoking before surgery or how quitting smoking can improve recovery from a fracture injury. Additional information includes the benefits of quitting smoking and developing coping strategies during a quit attempt. Motivational emails and references to free resources for additional smoking cessation support will also be provided. | Behavioural | Intervention Arm: Virtual Group |
Primary outcome
Trial feasibility - Recruitment
Time frame: Surgery: 30 days after surgery; Fracture Clinic: 30 days
Feasibility as assessed by recruitment rate. This will be assessed as the proportion of participants who agree to participate compared to the number of patients who had met the inclusion/exclusion criteria and were approached to participate in the study. The demographics of those who declined to participate or dropped out of the virtual program will be assessed for trends within the population who do not wish to participate in the virtual smoking cessation program
Trial feasibility - Acceptability of the email message program component
Time frame: Surgery: 30 Days after surgery; Fracture Clinic: 30 days after study recruitment
Patients will be asked to evaluate the email program and messages provided during their participation in the virtual program through a questionnaire that will evaluate the frequency, length, content, delivery, and duration of the email message component using a 5-point Likert scale.
Trial feasibility - Acceptability of e-learning module program component
Time frame: Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment
Patients will be asked to evaluate the e-learning module once they completed it. A survey will be administered to evaluate the content and comprehension of the e-learning module using a 5-point Likert scale.
Trial feasibility - EPIC patient portal usage
Time frame: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
The feasibility of delivering this virtual program through the patient portal will be assessed by the proportion of study participants who have self-reported patient portal use compared to the total number of study participants.
Trial feasibility - Retention
Time frame: Surgery: 30 days after surgery; Fracture Clinic: 30 days
Feasibility as assessed by the retention rates. This will be defined as the proportion of program participants completing the study at the final follow-up compared to the participants enrolled. Reasons for withdrawal will also be recorded to assess any trends that occur among participants who drop out.
8 secondary outcomes
Module Education
Time frame: At time of recruitment, and after module completion (Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment)
Cigarettes smoked
Time frame: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
Quit attempts
Time frame: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
Nicotine Dependence
Time frame: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
Stage of change
Time frame: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
Self or assisted quit attempt
Time frame: Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up
Complications/Adverse Events
Time frame: Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment
Readmission
Time frame: Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment
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 30 Mar 2025.
- Background: PubMed 27274333Graham AL, Carpenter KM, Cha S, Cole S, Jacobs MA, Raskob M, Cole-Lewis H. Systematic review and meta-analysis of Internet interventions for smoking cessation among adults. Subst Abuse Rehabil. 2016 May 18;7:55-69. doi: 10.2147/SAR.S101660. eCollection 2016.
- Background: PubMed 1932883Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
- Background: PubMed 11725245Andersen T, Christensen FB, Laursen M, Hoy K, Hansen ES, Bunger C. Smoking as a predictor of negative outcome in lumbar spinal fusion. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2623-8. doi: 10.1097/00007632-200112010-00018.
- Background: PubMed 21295194Mills E, Eyawo O, Lockhart I, Kelly S, Wu P, Ebbert JO. Smoking cessation reduces postoperative complications: a systematic review and meta-analysis. Am J Med. 2011 Feb;124(2):144-154.e8. doi: 10.1016/j.amjmed.2010.09.013.
- Background: PubMed 21403009Myers K, Hajek P, Hinds C, McRobbie H. Stopping smoking shortly before surgery and postoperative complications: a systematic review and meta-analysis. Arch Intern Med. 2011 Jun 13;171(11):983-9. doi: 10.1001/archinternmed.2011.97. Epub 2011 Mar 14.
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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.
Jean Wong, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Smoking Cessation Program in people with Smoking and Smoking Cessation, run by University Health Network, Toronto at 1 site in Canada.
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 7 inclusion and 6 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Trial feasibility - Recruitment (time frame: Surgery: 30 days after surgery; Fracture Clinic: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05594199, which also lists 5 linked publications.
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 30 Mar 2025.