Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

Tobacco Use Cessation Clinical Trial

Official title:

Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04020718
• Other study ID #: 2019A005710
• Status: Completed
• Phase: Phase 4
• Start date: January 31, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	Massacusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Self-reported Change in Average Number of Cigarettes Smoked Per Day	Self-reported change in average cigarettes smoked per day	12 weeks post-randomization