Development of a mHealth Intervention for Ambivalent Smokers

Smoking Cessation Clinical Trial

Official title:

Development of a mHealth Intervention for Ambivalent Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04560868
• Other study ID #: 1401452
• Secondary ID: R21CA234003
• Status: Completed
• Phase: Phase 1
• Start date: December 16, 2020
• Est. completion date: September 27, 2021

Study information

• Verified date: January 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Behavior, Smoking
• Motivation
• Smoking Cessation
• Tobacco Use Disorder

Intervention

Device:
• Control mHealth program
The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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