My Mobile Advice Program: A Randomized Pilot Feasibility Study

Not Applicable

Completed

• Conditions: Smoking Cessation; Medication Adherence
• Interventions: Drug: Varenicline; Behavioral: Cognitive-behavioral self-help; Behavioral: MyMAP (My Mobile Advice Program)

• Registration Number: NCT02136498
• Lead Sponsor: Kaiser Permanente

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-13
• Study Start: 2014-10
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2016-08-15
• Results First Submitted QC: 2016-08-15
• Results First Posted: 2016-10-10
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mHealth MyMAP program + varenicline	Cognitive-behavioral self-help	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.
mHealth MyMAP program + varenicline	MyMAP (My Mobile Advice Program)	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.
mHealth MyMAP program + varenicline	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.
mHealth self-help + varenicline	Cognitive-behavioral self-help	Participants in this control arm received standard cognitive-behavioral self-help materials delivered via a mobile health (mHealth) program + a standard course of varenicline.
mHealth self-help + varenicline	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.

Primary Outcome Measures

Name	Time	Method
Point Prevalence Abstinence	5 month follow-up	Self-report of no-smoking, even a puff during the last 7 days.

Secondary Outcome Measures

Name	Time	Method
Number of Days of Varenicline Use	5 mo follow-up	Number of days varenicline was used

Trial Locations

Locations (1)

Group Health Research Institute; 🇺🇸 Seattle, Washington, United States