An Interactive Smartphone Application to Motivate Smokers to Quit

Study Overview
=================
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.

Official Title
-----------------
An Interactive Smartphone Application to Motivate Smokers to Quit

Conditions
-----------------
Smoking Cessation, Smoking Behaviors

Intervention / Treatment
-----------------
* Behavioral: StepOne Smartphone Application


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Eligible smokers randomized to usual care will receive an educational brochure for the University of Ottawa Heart Institute's Ottawa Model for Smoking Cessation (OMSC) Community Program. The brochure will include information about the OMSC Community Program and how to register for it to receive assistance to quit smoking. | |
| Experimental: Intervention<br>Eligible smokers randomized to the intervention group will be asked to download the StepOne smartphone application onto their smartphone via the Apple Store or Google Play Store. They will be provided with a unique ID and unique code, which will enable them to log into the StepOne smartphone application to begin the 14-day program. Users will interact with the application in the morning and evening; the exact time of the engagement is selected by the participant and ideally at a time that maximizes the likelihood of engaging with the activity. The application incorporates interactive educational material, daily reminders, gamification, and models of habit formation to engage users. As with any other smartphone application, users can turn off notifications if they choose to do so. New content and activities will be shared daily. | Behavioral: StepOne Smartphone Application<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported readiness to quit | Collected via survey | Day 14 | 
| Self-reported readiness to quit | Collected via survey | Day 45 | 
| Self-reported readiness to quit | Collected via survey | Day 195 | 
| Having made a quit attempt | Collected via survey | Day 14 | 
| Having made a quit attempt | Collected via survey | Day 45 | 
| Having made a quit attempt | Collected via survey | Day 195 | 
| Rate of smoking cessation | Biochemically verified using an expired carbon monoxide (CO) test | Day 45 for participants who report smoking cessation | 
| Rate of smoking cessation | Biochemically verified using an expired carbon monoxide (CO) test | Day 195 for participants who report smoking cessation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that made a quit attempt | Collected via survey | Day 14, 45, 195 | 
| Change in smoking | Collected via survey | Day 14, 45, 195 | 
| Point prevalence abstinence | Collected via survey | Day 14, 45, 195 | 
| Use of behavioural supports (e.g. counselling, quit lines) | Collected via survey | Day 14, 45, 195 | 
| Use of cessation medication and/or e-cigarettes | Collected via survey | Day 14, 45, 195 | 
| Satisfaction and perceived program barriers and facilitators will be assessed for patients in the intervention group | Collected via survey | Day 14, 45, 195 |