An Interactive Smartphone Application to Motivate Smokers to Quit (StepOne)

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Smoking Behaviors
• Intervention / Treatment: Behavioral: StepOne Smartphone Application

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.

• Study Type: Interventional
• Enrollment (Estimated): 382
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zain Saleem; Phone Number: 14789 613-696-7000; Email: zsaleem@ottawaheart.ca
• Study Contact Backup: Name: Ashley Baldwin; Phone Number: 613-696-7000; Email: abaldwin@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4W7
      • Recruiting
      • The University of Ottawa Heart Institute
      • Principal Investigator: Hassan Mir, MD
      • Contact: Ashley Baldwin; Phone Number: 14377 613-696-7000; Email: asbaldwin@ottawaheart.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; 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; 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; 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.

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
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
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

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Hassan Mir, MD, The University of Ottawa Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20220696-01H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No