My Mobile Advice Program: A Randomized Pilot Feasibility Study
NCT ID: NCT02136498
Last Updated: 2017-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2014-10-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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mHealth self-help + varenicline
Participants in this control arm received standard cognitive-behavioral self-help materials delivered via a mobile health (mHealth) program + a standard course of varenicline.
Varenicline
Standard 12 week course of varenicline, provided in both arms
Cognitive-behavioral self-help
Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.
mHealth MyMAP program + varenicline
Participants in the experimental arm received standard cognitive-behavioral self-help materials delivered via a mHealth program + additional personalized support features (automated, tailored advice managing nicotine withdrawal symptoms and medication side-effects \& secure messaging with a cessation counselor; i.e., MyMAP program) + a standard course of varenicline.
Varenicline
Standard 12 week course of varenicline, provided in both arms
Cognitive-behavioral self-help
Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.
MyMAP (My Mobile Advice Program)
Same standard self-help intervention as in control arm + automatically-tailored support and advice for managing nicotine withdrawal symptoms + secure messaging with cessation counselor
Interventions
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Varenicline
Standard 12 week course of varenicline, provided in both arms
Cognitive-behavioral self-help
Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.
MyMAP (My Mobile Advice Program)
Same standard self-help intervention as in control arm + automatically-tailored support and advice for managing nicotine withdrawal symptoms + secure messaging with cessation counselor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plan to remain enrolled in Group Health for the next 6 months
* aged 18 - 65
* Eligible for smoking cessation treatment through Group Health insurance coverage
* smoke \>= 10 cigs a day
* speak and read in English
* willing to use varenicline and no contraindications for this medication
* ready to quit smoking
* have a smart phone with internet access
* willing to receive study texts and emails
* receive care at a Group Health clinic and have electronic medical records in this system
* fill prescriptions through the Group Health pharmacy
* agree to use birth control while taking study medication, if there is a risk of pregnancy
Exclusion Criteria
* psychosis or bipolar disorder based on self-report or medical record review
* hearing, comprehension or visual limitations that preclude full study participation
* current use of other forms of tobacco
* any medical contraindication for varenicline use
* documented history of suicidal ideation/intent
18 Years
65 Years
ALL
No
Sponsors
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University of Michigan
OTHER
University of California, Davis
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Jennifer McClure, PhD
Role: PRINCIPAL_INVESTIGATOR
Group Health Research Institute
Sheryl Catz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Larry An, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Group Health Research Institute
Seattle, Washington, United States
Countries
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References
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McClure JB, Anderson ML, Bradley K, An LC, Catz SL. Evaluating an Adaptive and Interactive mHealth Smoking Cessation and Medication Adherence Program: A Randomized Pilot Feasibility Study. JMIR Mhealth Uhealth. 2016 Aug 3;4(3):e94. doi: 10.2196/mhealth.6002.
Related Links
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Primary outcome paper
Other Identifiers
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