Applying mHealth to Tobacco-related Health Disparities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2020-12-14

Brief Summary

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The purpose of this study is to better understand what happens when someone attempts to quit smoking.

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Detailed Description

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Investigators will provide participants with nicotine patches, smoking cessation treatment that will include brief counseling sessions (10-15 minutes each), and text messages sent to their provided study phone throughout the day. These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts. Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior. Mobile Health (mHealth) is a general term for the use of mobile phones and other wireless technology in medical care.

The key outcome and hypothesized mechanisms (i.e., lapse and stress) will be measured objectively and automatically using AutoSense. AutoSense is a type of human sensing technology that allows investigators to detect smoking behavior and stress objectively through a chest strap and wrist bands worn by participants. Ecological momentary assessment (EMA) will assess acute precipitants such as negative affect, craving, self-efficacy, motivation, alcohol consumption, etc. Questionnaires will assess other predictors and mechanisms.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Smoking Cessation Therapy

Participants will receive 6 weeks of the nicotine patch therapy and brief counseling sessions. Participants will also receive mindfulness strategies for 10 days during both the pre- and post-quit periods via smartphone to aid in their cessation attempt. AutoSense will be worn to detect stress and lapse throughout the 10 day period.

Group Type EXPERIMENTAL

Nicotine Patch

Intervention Type DRUG

Nicotine patches and thorough education of the indications for the patch will be provided to all participants.

Counseling

Intervention Type BEHAVIORAL

Brief counseling sessions, 10-15 minutes each.

Smartphone

Intervention Type BEHAVIORAL

Ecological momentary assessment (EMA) assesses participants' moment-to-moment subjective experiences via self-report assessments on a smart phone. Participants will receive mindfulness strategies for 10 days pre- and post-quit via smart phone to aid in their cessation attempt. Text messages will be sent to provided study phones throughout the day. These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts.

AutoSense

Intervention Type OTHER

Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior. AutoSense unobtrusively and objectively collects physiological and behavioral data (i.e., negative affect (NA), self-regulatory capacity (SRC), and smoking) via wearable chest and wrist sensors.

Interventions

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Nicotine Patch

Nicotine patches and thorough education of the indications for the patch will be provided to all participants.

Intervention Type DRUG

Counseling

Brief counseling sessions, 10-15 minutes each.

Intervention Type BEHAVIORAL

Smartphone

Ecological momentary assessment (EMA) assesses participants' moment-to-moment subjective experiences via self-report assessments on a smart phone. Participants will receive mindfulness strategies for 10 days pre- and post-quit via smart phone to aid in their cessation attempt. Text messages will be sent to provided study phones throughout the day. These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts.

Intervention Type BEHAVIORAL

AutoSense

Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior. AutoSense unobtrusively and objectively collects physiological and behavioral data (i.e., negative affect (NA), self-regulatory capacity (SRC), and smoking) via wearable chest and wrist sensors.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Smoked a minimum of 3 cigarettes per day over the past year
* Expired carbon monoxide reading ≥ 6
* Motivated to quit within the next 30 days
* Valid home address
* Functioning telephone number
* Can speak, read, and write in English
* At least marginal health literacy

Exclusion Criteria

* Contraindication for the nicotine patch (e.g., heart attack, angina, skin allergies) unless a doctor's note is provided
* Endorse current psychosis
* Have a pacemaker or implanted device
* Physically unable to wear equipment and provide a good reading of physiological measures
* Current use of tobacco cessation medications
* Current use of of smoking products other than cigarettes and e-cigarettes
* Involvement in a smoking program or currently trying to quit
* Pregnancy or lactation
* Another household member being enrolled in the study
* No prior experience with a smart phone
* The study staff or principal investigator (PI) have serious concerns about the participant's ability to engage in and/or complete the study protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes