Trial of An Innovative Smartphone Intervention for Smoking Cessation

Study Overview
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Brief Summary
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The goal of this study is to determine whether the novel smartphone app (SmartQuit) provides higher quit rates than the current standard smoking cessation app.

Official Title
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Randomized Trial of An Innovative Smartphone Intervention for Smoking Cessation

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Smartphone-delivered Intervention (SmartQuit)
* Behavioral: : Smartphone-delivered Intervention (Standard of care app)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or older smokes at least five cigarettes daily for at least past 12 months wants to quit cigarette smoking in the next 30 days if concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days interested in learning skills to quit smoking willing to be randomly assigned to either condition resides in US has at least daily access to their own personal Apple iPhone, Android, or Windows Phone knows how to login and download a smartphone application willing and able to read in English not using other smoking cessation interventions (including apps or our other intervention studies). willing to complete all three follow-up surveys provide email, phone, and mailing address. Exclusion Criteria: The exclusion criteria are opposite of the inclusion criteria listed above.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>This is the experimental arm of the study. This includes receiving the novel/experimental smartphone smoking cessation app. Therapy description withheld to protect the integrity of the study. | Behavioral: Smartphone-delivered Intervention (SmartQuit)<br>* The experimental arm includes an intervention using a novel smartphone smoking cessation app.<br>|
| Active Comparator: Control<br>This is the control arm of the study. This includes receiving the standard of care smartphone smoking cessation app. Therapy description withheld to protect the integrity of the study. | Behavioral: : Smartphone-delivered Intervention (Standard of care app)<br>* The control intervention uses a standard of care smartphone smoking cessation app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day Point Prevalence Abstinence, Complete-case | Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are excluded for the complete-case analysis. Exact 2-sided CI was based on the observed proportion of participants. | 12 months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day Point Prevalence Abstinence, Missing=Smoking Imputation | Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are imputed as still smoking. Exact 2-sided CI was based on the observed proportion of participants. | 12 months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, app for quitting smoking