An Interactive Smartphone Application to Motivate Smokers to Quit

Smoking Cessation Clinical Trial

— StepOne  

Official title:

An Interactive Smartphone Application to Motivate Smokers to Quit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799625
• Other study ID #: 20220696-01H
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: Zain Saleem
• Phone: 613-696-7000
• Email: zsaleem[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 382
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Behaviors
• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
Canada	The University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported readiness to quit	Collected via survey	Day 14
Primary	Self-reported readiness to quit	Collected via survey	Day 45
Primary	Self-reported readiness to quit	Collected via survey	Day 195
Primary	Having made a quit attempt	Collected via survey	Day 14
Primary	Having made a quit attempt	Collected via survey	Day 45
Primary	Having made a quit attempt	Collected via survey	Day 195
Primary	Rate of smoking cessation	Biochemically verified using an expired carbon monoxide (CO) test	Day 45 for participants who report smoking cessation
Primary	Rate of smoking cessation	Biochemically verified using an expired carbon monoxide (CO) test	Day 195 for participants who report smoking cessation
Secondary	Number of participants that made a quit attempt	Collected via survey	Day 14, 45, 195
Secondary	Change in smoking	Collected via survey	Day 14, 45, 195
Secondary	Point prevalence abstinence	Collected via survey	Day 14, 45, 195
Secondary	Use of behavioural supports (e.g. counselling, quit lines)	Collected via survey	Day 14, 45, 195
Secondary	Use of cessation medication and/or e-cigarettes	Collected via survey	Day 14, 45, 195
Secondary	Satisfaction and perceived program barriers and facilitators will be assessed for patients in the intervention group	Collected via survey	Day 14, 45, 195