Clinical trial NCT02136498: My Mobile Advice Program: A Randomized Pilot Feasibility Study
Official title: Internet-based Medication Adherence Program for Nicotine Dependence Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Medication Adherence
Keywords: smoking cessation
varenicline
adherence
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: University of California, Davis
First posted: 2014-05-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Point Prevalence Abstinence
timeFrame: 5 month follow-up
Secondary outcomes:
measure: Number of Days of Varenicline Use
timeFrame: 5 mo follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Group Health Research Institute
name: Jennifer McClure, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Sheryl Catz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Larry An, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.