Clinical trial NCT05799625: An Interactive Smartphone Application to Motivate Smokers to Quit
Official title: An Interactive Smartphone Application to Motivate Smokers to Quit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Smoking Behaviors
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Self-reported readiness to quit
timeFrame: Day 14
measure: Self-reported readiness to quit
timeFrame: Day 45
measure: Self-reported readiness to quit
timeFrame: Day 195
measure: Having made a quit attempt
timeFrame: Day 14
measure: Having made a quit attempt
timeFrame: Day 45
measure: Having made a quit attempt
timeFrame: Day 195
measure: Rate of smoking cessation
timeFrame: Day 45 for participants who report smoking cessation
measure: Rate of smoking cessation
timeFrame: Day 195 for participants who report smoking cessation
Secondary outcomes:
measure: Number of participants that made a quit attempt
timeFrame: Day 14, 45, 195
measure: Change in smoking
timeFrame: Day 14, 45, 195
measure: Point prevalence abstinence
timeFrame: Day 14, 45, 195
measure: Use of behavioural supports (e.g. counselling, quit lines)
timeFrame: Day 14, 45, 195
measure: Use of cessation medication and/or e-cigarettes
timeFrame: Day 14, 45, 195
measure: Satisfaction and perceived program barriers and facilitators will be assessed for patients in the intervention group
timeFrame: Day 14, 45, 195
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: The University of Ottawa Heart Institute
name: Hassan Mir, MD
role: PRINCIPAL_INVESTIGATOR
References: