Phase 4
Completed N=153
A Text Messaging Program for Smokers in Primary Care
Source: ClinicalTrials.gov NCT03174158 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Quit Attempts — 26; 33; 29; 31 Participants — p=0.07
◆ Published Evidence
Emerging
12citations · ~2 / year
Proactively Offered Text Messages and Mailed Nicotine Replacement Therapy for Smokers in Primary Care Practices: A Pilot Randomized Trial.
Summary
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.
Linked Publications (2)
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Proactively Offered Text Messages and Mailed Nicotine Replacement Therapy for Smokers in Primary Care Practices: A Pilot Randomized Trial.
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Proactive text messaging (GetReady2Quit) and nicotine replacement therapy to promote smoking cessation among smokers in primary care: A pilot randomized trial protocol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quit Attempts |
26; 33; 29; 31 | 0.07 |
| SECONDARY 7 Day Point Prevalent Abstinence |
4; 10; 10; 9 | — |
| SECONDARY 7 Day Point Prevalent Abstinence |
4; 10; 10; 9 | — |
| SECONDARY Milligrams of Nicotine Medication Used |
84.2; 58.0 | — |
| SECONDARY Percentage of Days Not Smoked |
23.7; 37.2; 29.0; 36.1 | — |
| SECONDARY Exhaled Carbon Monoxide |
1; 3; 3; 2 | — |
| SECONDARY Days Nicotine Medication Used |
5.3; 3.3 | — |
| SECONDARY Milligrams Nicotine Medication Used |
33.8; 22.3 | — |
| SECONDARY Change in Cigarettes Per Day |
-9.3; -8.6; -11.3; -8.9 | — |
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, "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 nicotine patch
- Weight < 100 pounds
- Unstable coronary disease
- Unstable arrhythmia
- Dementia or active psychosis or schizoaffective disorder affecting ability to consent
- Willing and able to receive and participate with a text message program for up to 12 weeks
Data sourced from ClinicalTrials.gov (NCT03174158) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.