Development of a mHealth Intervention for Ambivalent Smokers
Overview
- Phase
- Phase 1
- Intervention
- Control mHealth program
- Conditions
- Tobacco Use Disorder
- Sponsor
- Kaiser Permanente
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Program Engagement
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Control
Intervention: Control mHealth program
Control
Intervention: Nicotine patch
Experimental
Intervention: Experimental mHealth program
Experimental
Intervention: Nicotine patch
Outcomes
Primary Outcomes
Program Engagement
Time Frame: Assessed at 3-month follow-up
Number of unique app user-sessions
Quit Attempt Lasting at Least 24 Hours
Time Frame: Assessed at 3-month follow-up
At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.
Not Smoking (Even a Puff) in the Last 7 Days
Time Frame: Assessed at 3-month follow-up
7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.
Secondary Outcomes
- Earned and Requested Free Nicotine Replacement Therapy(Assessed at 3-month follow-up)
- Program Engagement - Earned Badges(Assessed at 3-month follow-up)
- Self-efficacy to Quit Smoking(Assessed at 3 months)
- Quit Attempt Lasting at Least 24 Hours(Assessed at 1 month follow-up)
- Satisfaction With Assigned App(Assessed at 3 months)
- Self-efficacy to Stay Quit(Assessed at 3 months)
- Change in Cigarettes/Day(Assessed at baseline and 3 months)
- Refrain From Smoking (Even a Puff) in the Last 7 Days(Assessed at 1-month follow-up)
- Helpfulness of Assigned App(Assessed at 3 months)