Smoking Behaviors, Smoking Cessation
Conditions
Brief summary
Prospective, randomized, single-blinded, blinded-endpoint trial to determine the impact of a smartphone application-based program to motivate smokers to increase readiness to quit, make quit attempts, and quit smoking.
Detailed description
Prospective, randomized, single-blinded, blinded-endpoint trial to determine the impact of a smartphone application-based program to motivate smokers to increase readiness to quit, make quit attempts, and quit smoking. The intervention has been designed based by a team of scientist, taking principles of change behaviour into consideration. The application incorporates daily reminders, gamification, and models of habit formation to engage users. It will support participants to reflect on their smoking in a holistic manner through questions and activities.
Interventions
BEHAVIORALStepOne Smartphone Application
This smartphone application provides a 14-day program that delivers the core components of smoking cessation (i.e., counseling, education) and takes advantage of pandemic-accelerated acceptance of virtual care, videoconferencing, remote monitoring, and social networking. The program seeks to move participants from the pre-action stage (not interested in quitting) to the action stage (intention to quit) and incorporates daily reminders, gamification, and models of habit formation to engage users.
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Living in Ontario, Canada. * Current smoker who indicates they are not interested in quitting within the next 30-days. * Have access to and regularly use a smartphone with internet access. * Read, write, speaks English or French. * Available and willing to participate in follow-up assessments over the next 6 months. * Able to provide consent.
Exclusion criteria
* Planning on quitting smoking within the next 30-days. * Cognitively impaired or experiencing acute psychiatric illness that would alter their ability to participate. * Institutionalized at a retirement home, nursing home or long-term care facility. * Has morbid illness which will prevent completion of 6-month follow-up (e.g., receiving palliative care). * Participating in another smoking cessation program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported readiness to quit | Day 14 | Collected via survey |
| Having made a quit attempt | Day 14 | Collected via survey |
| Rate of smoking cessation | Day 45 for participants who report smoking cessation | Biochemically verified using an expired carbon monoxide (CO) test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that made a quit attempt | Day 14, 45, 195 | Collected via survey |
| Change in smoking | Day 14, 45, 195 | Collected via survey |
| Point prevalence abstinence | Day 14, 45, 195 | Collected via survey |
| Use of behavioural supports (e.g. counselling, quit lines) | Day 14, 45, 195 | Collected via survey |
| Use of cessation medication and/or e-cigarettes | Day 14, 45, 195 | Collected via survey |
| Satisfaction and perceived program barriers and facilitators will be assessed for patients in the intervention group | Day 14, 45, 195 | Collected via survey |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORHassan Mir, MD
The University of Ottawa Heart Institute
Outcome results
None listed