A Text Messaging Program for Smokers in Primary Care

Description

This study is a four arm pilot randomized controlled trial testing the effect of a 12 week text messaging intervention and a mailed nicotine medication intervention, alone and in combination to a control condition consisting of brief behavioral advice and usual care. Research Aim 1: To test, in a 4 arm pilot randomized controlled trial (N=50/group), the effect of a text messaging program and mailed nicotine replacement therapy on smoking outcomes and medication use. Hypothesis 1: A text messaging intervention will increase the proportion of smokers making a quit attempt compared to smokers receiving no text messaging. Hypothesis 2: A text messaging intervention will increase adherence to nicotine replacement therapy compared to subjects receiving only 2 weeks of nicotine replacement therapy. Hypothesis 3: A text messaging intervention will increase the rate of biochemically confirmed past 7-day point prevalent tobacco abstinence at end of treatment compared to subjects receiving no text messaging intervention. Hypothesis 4: A text messaging intervention will increase the number of days not smoking compared to subjects receiving no text messaging intervention. Hypothesis 5: A text messaging intervention will decrease the number of cigarettes smoked per day compared to subjects receiving no text messaging intervention.

Study Start Date

September, 22 2017

Estimated Completion Date

October 2018

Interventions

  • Behavioral: Text messaging
  • Drug: Mailed nicotine replacement therapy
  • Behavioral: Brief advice

Study ID

Massachusetts General Hospital -- 2017P000960

Status

Recruiting

Trial ID

NCT03174158

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

206

Sponsor

Massachusetts General Hospital

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 primary care provider (PCP)
  • PCP visit in the past 2 years
  • Mobile telephone number listed in EHR

Exclusion Criteria

  • Not a current smoker defined as not having smoked ?100 cigarettes in lifetime or self-report of no 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, "QuitWorks" 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 adhesive tape, such as bandaids or medical tape
  • Weight < 100 pounds
  • New or increasing chest pain or heart attack in the past 30 days
  • Ever been told by a doctor that patient has an irregularly fast, abnormal heartbeat
  • Ever been told by a doctor that patient has dementia, psychosis or schizoaffective disorder.
  • Willing and able to receive and participate with a text message program for up to 12 weeks

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Massacusetts General Hospital - Boston, Massachusetts 2.8 miles Gina R Kruse MD 617-724-3157 gkruse@partners.org
Massacusetts General Hospital - Boston, Massachusetts 2.8 miles Gina R Kruse MD 617-724-3157 gkruse@partners.org
Massacusetts General Hospital - Boston, Massachusetts 2.8 miles Gina R Kruse MD 617-724-3157 gkruse@partners.org
Massacusetts General Hospital - Boston, Massachusetts 2.8 miles Gina R Kruse MD 617-724-3157 gkruse@partners.org
Massacusetts General Hospital - Boston, Massachusetts 2.8 miles Gina R Kruse MD 617-724-3157 gkruse@partners.org

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