Clinical trial NCT04560868: Development of a mHealth Intervention for Ambivalent Smokers
Official title: Development of a mHealth Intervention for Ambivalent Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Use Disorder
Smoking Cessation
Motivation
Behavior, Smoking
Keywords: mHealth
smoking
smoking cessation
motivation
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-23
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Program Engagement
timeFrame: Assessed at 3-month follow-up
measure: Quit Attempt Lasting at Least 24 Hours
timeFrame: Assessed at 3-month follow-up
measure: Not Smoking (Even a Puff) in the Last 7 Days
timeFrame: Assessed at 3-month follow-up
Secondary outcomes:
measure: Satisfaction With Assigned App
timeFrame: Assessed at 1 month
measure: Satisfaction With Assigned App
timeFrame: Assessed at 3 months
measure: Helpfulness of Assigned App
timeFrame: Assessed at 1 month.
measure: Helpfulness of Assigned App
timeFrame: Assessed at 3 months
measure: Program Engagement - Earned Badges
timeFrame: Assessed at 1-month follow-up
measure: Program Engagement - Earned Badges
timeFrame: Assessed at 3-month follow-up
measure: Self-efficacy to Quit Smoking
timeFrame: Assessed at 1 month
measure: Self-efficacy to Quit Smoking
timeFrame: Assessed at 3 months
measure: Self-efficacy to Stay Quit
timeFrame: Assessed at 1 month
measure: Self-efficacy to Stay Quit
timeFrame: Assessed at 3 months
measure: Earned and Requested Free Nicotine Replacement Therapy
timeFrame: Assessed at 1-month follow-up
measure: Earned and Requested Free Nicotine Replacement Therapy
timeFrame: Assessed at 3-month follow-up
measure: Quit Attempt Lasting at Least 24 Hours
timeFrame: Assessed at 1 month follow-up
measure: Change in Cigarettes/Day
timeFrame: Assessed at baseline and 1 month
measure: Change in Cigarettes/Day
timeFrame: Assessed at baseline and 3 months
measure: Refrain From Smoking (Even a Puff) in the Last 7 Days
timeFrame: Assessed at 1-month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Jennifer McClure, PhD
role: PRINCIPAL_INVESTIGATOR
References: