Smoking Cessation Clinical Trial
Official title:
Development of a mHealth Intervention for Ambivalent Smokers
Verified date | January 2023 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | September 27, 2021 |
Est. primary completion date | September 27, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Washington Health Research Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Program Engagement | Number of unique app user-sessions | Assessed at 3-month follow-up | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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. | |
Secondary | 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 | |
Secondary | Program Engagement - Earned Badges | Number of accumulated badge rewards earned from using the assigned app. | Assessed at 1-month follow-up | |
Secondary | Program Engagement - Earned Badges | Number of accumulated badge rewards earned from using the assigned app. | Assessed at 3-month follow-up | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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