NCT04020718

Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-31
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2019-07-16
• Last updated: 2022-03-10
• Results posted: 2022-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study