Development of a mHealth Intervention for Ambivalent Smokers

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 Overview

• Status: Completed
• Conditions: Smoking Cessation; Tobacco Use Disorder; Motivation; Behavior, Smoking
• Intervention / Treatment: Device: Control mHealth program; Drug: Nicotine patch; Device: Experimental mHealth program

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Kaiser Permanente Washington Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	Drug: Nicotine patch; 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.; Device: Experimental mHealth program; 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.
Active Comparator: Control	Device: Control mHealth program; The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.; Drug: Nicotine patch; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jennifer McClure, PhD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: smoking; smoking cessation; mHealth; motivation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 1401452; R21CA234003 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No