Internet-based Medication Adherence Program for Nicotine Dependence Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Varenicline
- Conditions
- Smoking Cessation
- Sponsor
- Kaiser Permanente
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Point Prevalence Abstinence
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
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.
Intervention: Varenicline
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.
Intervention: Cognitive-behavioral self-help
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.
Intervention: Varenicline
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.
Intervention: Cognitive-behavioral self-help
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.
Intervention: MyMAP (My Mobile Advice Program)
Outcomes
Primary Outcomes
Point Prevalence Abstinence
Time Frame: 5 month follow-up
Self-report of no-smoking, even a puff during the last 7 days.
Secondary Outcomes
- Number of Days of Varenicline Use(5 mo follow-up)