Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

NCT04020718 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2019A005710
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use Cessation

Keywords

mobile health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks

  8 weeks post-randomization

• Exhaled Carbon Monoxide Less Than 8 Parts Per Million

  12 weeks post-randomization

• Self-reported Number of Days Nicotine Lozenge and/or Patch Used

  12 weeks post-randomization

• Self-reported Change in Average Number of Cigarettes Smoked Per Day

  12 weeks post-randomization

Study Arms (2)

Early assessment

EXPERIMENTAL

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; Drug: Mailed nicotine replacement therapy; Behavioral: Proactive telephone coaching

Late assessment

EXPERIMENTAL

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; Drug: Mailed nicotine replacement therapy; Behavioral: Proactive telephone coaching

Interventions

Brief telephone advice plus tailored text messages BEHAVIORAL

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.

Early assessment; Late assessment

Mailed nicotine replacement therapy DRUG

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).

Early assessment; Late assessment

Proactive telephone coaching BEHAVIORAL

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.

Early assessment; Late assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massacusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Kruse GR, Joyce A, Yu L, Park ER, Neil J, Chang Y, Rigotti NA. A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke. J Subst Use Addict Treat. 2023 Feb;145:208930. doi: 10.1016/j.josat.2022.208930. Epub 2023 Jan 6.

  PMID: 36880910 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Gina Kruse
• Organization: Massachusetts General Hospital

gkruse@mgh.harvard.edu

6177243157

Study Officials

• Gina R Kruse, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pilot sequential multiple assignment randomized trial

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 16, 2019
• Study Start: January 31, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: March 10, 2022
• Results First Posted: March 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)