Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Brief telephone advice plus tailored text messages; Drug: Mailed nicotine replacement therapy; Behavioral: Proactive telephone coaching

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massacusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Early assessment; 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.	Behavioral: Brief telephone advice plus tailored text messages; All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit and quit date. Content is personalized with user's name and Massachusetts General Hospital resources.; Drug: Mailed nicotine replacement therapy; Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette).; Behavioral: Proactive telephone coaching; Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.
EXPERIMENTAL: Late assessment; 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.	Behavioral: Brief telephone advice plus tailored text messages; All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit and quit date. Content is personalized with user's name and Massachusetts General Hospital resources.; Drug: Mailed nicotine replacement therapy; Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette).; Behavioral: Proactive telephone coaching; Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks	7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"	12 weeks post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks	7-day point prevalence abstinence (0, abstinent; 1, smoking)	8 weeks post-randomization
Exhaled Carbon Monoxide Less Than 8 Parts Per Million	Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment	12 weeks post-randomization
Self-reported Number of Days Nicotine Lozenge and/or Patch Used	Number of days when patch and/or lozenge was used	12 weeks post-randomization
Self-reported Change in Average Number of Cigarettes Smoked Per Day	Self-reported change in average cigarettes smoked per day	12 weeks post-randomization

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Gina R Kruse, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2020
• Primary Completion (ACTUAL): November 30, 2020
• Study Completion (ACTUAL): November 30, 2020

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (ACTUAL): July 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: mobile health
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2019A005710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No