My Mobile Advice Program: A Randomized Pilot Feasibility Study

Study Overview
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Brief Summary
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The purpose of this pilot study is to evaluate the acceptability and feasibility of the proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).

Detailed Description
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Investigators will develop and pilot test a prototype of the MyMAP intervention.The intervention is designed to help smokers better manage issues known to reduce treatment adherence (withdrawal symptoms, medication side-effects, low motivation, and inadequate behavioral skills for medication adherence) and to facilitate greater communication between patients and providers so clinicians can provide appropriate oversight of medication use, intervene when medically necessary, and address patient concerns that may otherwise lead to non-adherence or early treatment termination.

Official Title
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Internet-based Medication Adherence Program for Nicotine Dependence Treatment

Conditions
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Smoking Cessation, Medication Adherence

Intervention / Treatment
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* Drug: Varenicline
* Behavioral: Cognitive-behavioral self-help
* Behavioral: MyMAP (My Mobile Advice Program)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An invited member of Group Health, a health care system in the Pacific Northwest 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: lifetime history of dementia 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mHealth self-help + varenicline<br>Participants in this control arm received standard cognitive-behavioral self-help materials delivered via a mobile health (mHealth) program + a standard course of varenicline. | Drug: Varenicline<br>* Standard 12 week course of varenicline, provided in both arms<br>* Other names: Chantix;Behavioral: Cognitive-behavioral self-help<br>* Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.<br>|
| Experimental: mHealth MyMAP program + varenicline<br>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. | Drug: Varenicline<br>* Standard 12 week course of varenicline, provided in both arms<br>* Other names: Chantix;Behavioral: Cognitive-behavioral self-help<br>* Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.<br>Behavioral: MyMAP (My Mobile Advice Program)<br>* Same standard self-help intervention as in control arm + automatically-tailored support and advice for managing nicotine withdrawal symptoms + secure messaging with cessation counselor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point Prevalence Abstinence | Self-report of no-smoking, even a puff during the last 7 days. | 5 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days of Varenicline Use | Number of days varenicline was used | 5 mo follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, varenicline, adherence