Development of a mHealth Intervention for Ambivalent Smokers

Sponsor

Kaiser Permanente (Other)

Overall Status

Completed

CT.gov ID

NCT04560868

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

9.3

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder Smoking Cessation Motivation Behavior, Smoking	Device: Control mHealth program Device: Experimental mHealth program Drug: Nicotine patch	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Device Feasibility

Official Title:

Development of a mHealth Intervention for Ambivalent Smokers

Actual Study Start Date :

Dec 17, 2020

Actual Primary Completion Date :

Sep 27, 2021

Actual Study Completion Date :

Sep 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.
Experimental: Experimental	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. 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.

Arm

Intervention/Treatment

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.

Experimental: Experimental

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.

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.

Outcome Measures

Primary Outcome Measures

Smoking Cessation [Assessed at 3-month follow-up]
7-day point prevalent abstinence
Quit Attempt [Assessed at 3-month follow-up]
Intentional smoking quit attempt lasting at least 24 hours
Program Engagement [Assessed at 3-month follow-up]
Number of unique app user-sessions

Secondary Outcome Measures

Smoking Cessation [Assessed at 1-month follow-up]
7-day point prevalent abstinence
Smoking Reduction [Assessed at 1 and 3-month follow-up]
Reduction in number of cigarettes smoked per day
Self-efficacy [Assessed at 1 and 3-month follow-up]
Self-reported confidence can quit or stay quit
Helpfulness of assigned app [Assessed at 1 and 3-month follow-up]
Overall rating of helpfulness based on mean rating across program features
Satisfaction of assigned app [Assessed at 1 and 3-month follow-up]
Overall rating of satisfaction based on mean rating across program features
Program Engagement - Earned badges [Assessed at 1 and 3-month follow-up]
Average number of accumulated badge rewards
Nicotine Replacement Therapy [Assessed at 1 and 3-month follow-up]
Number of participants by arm who requested free nicotine patches
Quit Attempt [Assessed at 1 month follow-up]
Intentional smoking quit attempt lasting at least 24 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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