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Smoking Cessation

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT05799625

Conditions

Smoking Cessation

Smoking Behaviors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

StepOne Smartphone Application

Study Details

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.

Conditions

Smoking Cessation

Smoking Behaviors

Study ID

NCT05799625

Start date

Mar 12, 2024

Status verified date

Nov, 2024

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

382 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Self-reported readiness to quit [ Time Frame: Day 14 ]
  • Self-reported readiness to quit [ Time Frame: Day 45 ]
  • Self-reported readiness to quit [ Time Frame: Day 195 ]
  • Having made a quit attempt [ Time Frame: Day 14 ]
  • Having made a quit attempt [ Time Frame: Day 45 ]
  • Having made a quit attempt [ Time Frame: Day 195 ]
  • Rate of smoking cessation [ Time Frame: Day 45 for participants who report smoking cessation ]
  • Rate of smoking cessation [ Time Frame: Day 195 for participants who report smoking cessation ]

Central Contacts and Locations

Locations

The University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y4W7

Contacts

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Nov 19, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2024-11-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.