Development of a mHealth Intervention for Ambivalent Smokers

Kaiser Permanente57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

DOUBLE

Enrollment

Conditions

Tobacco Use Disorder Smoking Cessation Motivation Behavior, Smoking

Interventions

Control mHealth programDEVICE

The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.

Experimental mHealth programDEVICE

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.

Nicotine patchDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States

Outcomes

Primary Outcomes

Program Engagement

Number of unique app user-sessions

Time frame: 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.

Time frame: 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.

Time frame: Assessed at 3-month follow-up

Secondary Outcomes

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".

Time frame: 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".

Time frame: 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".

Time frame: 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".

Data from ClinicalTrials.gov

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