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Clinical Trials/NCT05799625
NCT05799625
Active, Not Recruiting
N/A

An Interactive Smartphone Application to Motivate Smokers to Quit

Ottawa Heart Institute Research Corporation1 site in 1 country382 target enrollmentMarch 12, 2024

Overview

Phase
N/A
Intervention
Usual Care
Conditions
Smoking Cessation
Sponsor
Ottawa Heart Institute Research Corporation
Enrollment
382
Locations
1
Primary Endpoint
Self-reported readiness to quit
Status
Active, Not Recruiting
Last Updated
2 months ago

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.

Registry
clinicaltrials.gov
Start Date
March 12, 2024
End Date
December 1, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

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.

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.

Intervention: StepOne Smartphone Application

Outcomes

Primary Outcomes

Self-reported readiness to quit

Time Frame: Day 195

Collected via survey

Having made a quit attempt

Time Frame: Day 195

Collected via survey

Rate of smoking cessation

Time Frame: Day 195 for participants who report smoking cessation

Biochemically verified using an expired carbon monoxide (CO) test

Self-reported readiness to quit

Time Frame: Day 14

Collected via survey

Self-reported readiness to quit

Time Frame: Day 45

Collected via survey

Having made a quit attempt

Time Frame: Day 14

Collected via survey

Having made a quit attempt

Time Frame: Day 45

Collected via survey

Rate of smoking cessation

Time Frame: Day 45 for participants who report smoking cessation

Biochemically verified using an expired carbon monoxide (CO) test

Secondary Outcomes

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

Study Sites (1)

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