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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05799625
Other study ID # 20220696-01H
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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