Clinical trial NCT04020718: Engagement With an Adaptive Mobile Health Smoking Cessation Intervention
Official title: Engagement With an Adaptive Mobile Health Smoking Cessation Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Use Cessation
Keywords: mobile health
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pilot sequential multiple assignment randomized trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks
timeFrame: 12 weeks post-randomization
Secondary outcomes:
measure: Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks
timeFrame: 8 weeks post-randomization
measure: Exhaled Carbon Monoxide Less Than 8 Parts Per Million
timeFrame: 12 weeks post-randomization
measure: Self-reported Number of Days Nicotine Lozenge and/or Patch Used
timeFrame: 12 weeks post-randomization
measure: Self-reported Change in Average Number of Cigarettes Smoked Per Day
timeFrame: 12 weeks post-randomization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massacusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gina R Kruse, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: