Development of a mHealth Intervention for Ambivalent Smokers

Study Overview
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Brief Summary
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The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking. Results will be used to refine the intervention and plan for a future randomized effectiveness trial.

Official Title
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Development of a mHealth Intervention for Ambivalent Smokers

Conditions
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Tobacco Use Disorder, Smoking Cessation, Motivation, Behavior, Smoking

Intervention / Treatment
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* Device: Control mHealth program
* Device: Experimental mHealth program
* Drug: Nicotine patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older; Can speak/read English; Current smoker; Own and regularly use an eligible smartphone; No vision impairments; Willing to install and use the study program; Willing to use birth control if elect to use nicotine replacement during the study (females); Meet definition for ambivalence Not actively using treatment Exclusion Criteria: Smoke less than 10 cigarettes per day Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia; Have medical contraindications for nicotine replacement therapy; Another household member is enrolled in the study Unable to verify contact information Fail to install app

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: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Device: Control mHealth program<br>* The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.<br>Drug: Nicotine patch<br>* Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.<br>|
| Experimental: Experimental<br> | Device: Experimental mHealth program<br>* The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.<br>Drug: Nicotine patch<br>* Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program Engagement | Number of unique app user-sessions | Assessed at 3-month follow-up | 
| Quit Attempt Lasting at Least 24 Hours | At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt. | Assessed at 3-month follow-up | 
| Not Smoking (Even a Puff) in the Last 7 Days | 7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking. | Assessed at 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction With Assigned App | Satisfaction with the overall content and advice of the assigned app, rated on a Likert scale from 1=not at all satisfied to 5=extremely satisfied. | Assessed at 1 month | 
| Satisfaction With Assigned App | Satisfaction with the overall content and advice of the assigned app on a Likert scale from 1=not at all satisfied to 5=extremely satisfied. | Assessed at 3 months | 
| Helpfulness of Assigned App | Global helpfulness rating calculated as the average helpfulness rating of 8 app features, each rated on a Likert scale from 1=not at all helpful to 5=extremely helpful. | Assessed at 1 month. | 
| Helpfulness of Assigned App | Average helpfulness rating of 8 separate app features, with each feature rated on a Likert scale from 1=not at all helpful to 5=extremely helpful. | Assessed at 3 months | 
| Program Engagement - Earned Badges | Number of accumulated badge rewards earned from using the assigned app. | Assessed at 1-month follow-up | 
| Program Engagement - Earned Badges | Number of accumulated badge rewards earned from using the assigned app. | Assessed at 3-month follow-up | 
| Self-efficacy to Quit Smoking | Self-reported confidence in quitting smoking on Likert scale from 1=not at all to 10=extremely. | Assessed at 1 month | 
| Self-efficacy to Quit Smoking | Self-reported confidence in quitting smoking on a Likert scale from 1=not at all to 10=extremely. | Assessed at 3 months | 
| Self-efficacy to Stay Quit | Self-reported confidence in ability to stay quit on a Likert scale from 1=not at all to 10=extremely. | Assessed at 1 month | 
| Self-efficacy to Stay Quit | Self-reported confidence in ability to stay quit (if no smoking in the past 7 days) on a Likert scale from 1=not at all to 10=extremely. | Assessed at 3 months | 
| Earned and Requested Free Nicotine Replacement Therapy | Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges. | Assessed at 1-month follow-up | 
| Earned and Requested Free Nicotine Replacement Therapy | Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges. | Assessed at 3-month follow-up | 
| Quit Attempt Lasting at Least 24 Hours | At least one intentional smoking quit attempt lasting at least 24 hours; non-respondents were assumed to not have a successful quit attempt. | Assessed at 1 month follow-up | 
| Change in Cigarettes/Day | Change in number of cigarettes smoked per day from baseline, calculated as (1 month)-baseline. | Assessed at baseline and 1 month | 
| Change in Cigarettes/Day | Change in number of cigarettes smoked per day from baseline, calculated as (3 months)-baseline. | Assessed at baseline and 3 months | 
| Refrain From Smoking (Even a Puff) in the Last 7 Days | 7-day point prevalent abstinence: a self-report of not smoking, even a puff, in the past 7 days. Missing outcomes were imputed as smoking. | Assessed at 1-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, smoking, smoking cessation, motivation