Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Tobacco Use Cessation

Treatments: Drug: Mailed nicotine replacement therapy; Behavioral: Brief telephone advice plus tailored text messages; Behavioral: Proactive telephone coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT04020718

2019A005710

Details and patient eligibility

About

This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (≥18 years)
• Smoking status of current smoker in structured field of electronic health record (EHR)
• Language listed as English in EHR
• Massachusetts General Hospital patient, Partners healthcare primary care provider (PCP)
• PCP visit in the past 2 years
• Mobile telephone number listed in EHR

Exclusion criteria

• Not a current daily smoker defined as not having smoked ≥100 cigarettes in lifetime or self-report of less than daily current smoking
• Pregnant, planning to become pregnant in the next 3 months, or breastfeeding.
• Past 30-day use of nicotine replacement therapy, bupropion, or varenicline.
• Past 30-day use of Massachusetts state quit-line or SmokefreeTXT programs
• Prior serious adverse reaction to the nicotine patch or lozenge defined as any reaction that was life-threatening, required hospitalization, or other clinical evaluation
• Ever had an allergy to nicotine patch
• Weight < 100 pounds
• Unstable coronary disease
• Unstable arrhythmia
• Dementia or active psychosis or schizoaffective disorder
• Willing and able to receive and participate with a text message program for up to 12 weeks
• Unable to read English or unable to write English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Early assessment

Experimental group

Description:

Patients are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.

Treatment:

Behavioral: Proactive telephone coaching

Behavioral: Brief telephone advice plus tailored text messages

Drug: Mailed nicotine replacement therapy

Late assessment

Experimental group

Description:

Patients are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.

Treatment:

Behavioral: Proactive telephone coaching

Behavioral: Brief telephone advice plus tailored text messages

Drug: Mailed nicotine replacement therapy