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Behavioral Intervention
Smartphone App for Quitting Smoking (StepOne Trial)
N/A
Recruiting
Led By Hassan Mir, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14, 45, 195
Awards & highlights
StepOne Trial Summary
This trial will measure if a smartphone app can help smokers quit by making them more motivated and ready to quit.
Who is the study for?
This trial is for smokers in Ontario, Canada who are over 18, can use a smartphone with internet, and speak English or French. They must not plan to quit smoking within the next month but be willing to follow up for 6 months. Those in long-term care or with illnesses preventing full participation are excluded.Check my eligibility
What is being tested?
The trial tests the StepOne Smartphone Application's effectiveness in motivating smokers to prepare to quit, attempt quitting, and succeed in quitting. Participants will be randomly assigned to use the app and their progress will be monitored without knowing which group they're in.See study design
What are the potential side effects?
Since this intervention involves using a smartphone application rather than medication, traditional side effects aren't expected. However, users may experience frustration or stress if they find it challenging to engage with the app or if it triggers cravings.
StepOne Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 14, 45, 195
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14, 45, 195
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Having made a quit attempt
Rate of smoking cessation
Self-reported readiness to quit
Secondary outcome measures
Change in smoking
Number of participants that made a quit attempt
Point prevalence abstinence
+3 moreStepOne Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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.
Group II: Usual CareActive Control1 Intervention
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.
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Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,054 Total Patients Enrolled
Hassan Mir, MDPrincipal InvestigatorThe University of Ottawa Heart Institute
4 Previous Clinical Trials
508 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not experiencing any severe mental health issues that would prevent me from participating.I am 18 years old or older.I am a smoker and do not plan to quit in the next 30 days.I am willing to attend follow-up assessments for the next 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals does this research endeavor strive to achieve?
"This trial will evaluate the success of participants on Day 195 in terms of making a quit attempt. Additionally, indices such as smoking reduction and point prevalence abstinence ascertained via survey, along with utilization of behavioural supports (i.e., counselling, quit lines) also need to be monitored."
Answered by AI
Is the recruitment period still open for this clinical experiment?
"Unfortunately, this medical trial is not presently accepting patients. According to the listing on clinicaltrials.gov, which was most recently updated on March 22nd 2023, no new candidates are being recruited at present. However, 165 other studies have active enrollment at this time."
Answered by AI
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