Development of a mHealth Intervention for Ambivalent Smokers

Phase 1

Completed

• Conditions: Motivation; Behavior, Smoking; Tobacco Use Disorder; Smoking Cessation
• Interventions: Device: Control mHealth program; Device: Experimental mHealth program; Drug: Nicotine patch

• Registration Number: NCT04560868
• Lead Sponsor: Kaiser Permanente

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2020-12-16
• Primary Completion: 2021-09-27
• Study Completion: 2021-09-27
• Results First Submitted: 2022-09-26
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-03
• Last Update Submitted: 2023-01-03
• Results First Posted: 2023-01-23
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control mHealth program	-
Control	Nicotine patch	-
Experimental	Experimental mHealth program	-
Experimental	Nicotine patch	-

Primary Outcome Measures

Name	Time	Method
Program Engagement	Assessed at 3-month follow-up	Number of unique app user-sessions
Quit Attempt Lasting at Least 24 Hours	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	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 Outcome Measures

Name	Time	Method
Earned and Requested Free Nicotine Replacement Therapy	Assessed at 3-month follow-up	Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.
Program Engagement - Earned Badges	Assessed at 3-month follow-up	Number of accumulated badge rewards earned from using the assigned app.
Self-efficacy to Quit Smoking	Assessed at 3 months	Self-reported confidence in quitting smoking on a Likert scale from 1="not at all" to 10="extremely".
Quit Attempt Lasting at Least 24 Hours	Assessed at 1 month follow-up	At least one intentional smoking quit attempt lasting at least 24 hours; non-respondents were assumed to not have a successful quit attempt.
Satisfaction With Assigned App	Assessed at 3 months	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".
Self-efficacy to Stay Quit	Assessed at 3 months	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".
Change in Cigarettes/Day	Assessed at baseline and 3 months	Change in number of cigarettes smoked per day from baseline, calculated as (3 months)-baseline.
Refrain From Smoking (Even a Puff) in the Last 7 Days	Assessed at 1-month follow-up	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.
Helpfulness of Assigned App	Assessed at 3 months	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".

Trial Locations

Locations (1)

Kaiser Permanente Washington Health Research Institute; 🇺🇸 Seattle, Washington, United States