Medication Adherence, Smoking Cessation
Conditions
Keywords
smoking cessation, varenicline, adherence
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.
Interventions
DRUGVarenicline
Standard 12 week course of varenicline, provided in both arms
BEHAVIORALCognitive-behavioral self-help
Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.
BEHAVIORALMyMAP (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
Sponsors
University of Michigan
University of California, Davis
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Point Prevalence Abstinence | 5 month follow-up | Self-report of no-smoking, even a puff during the last 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days of Varenicline Use | 5 mo follow-up | Number of days varenicline was used |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| mHealth Self-help + Varenicline Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.
Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc. | 33 |
| mHealth MyMAP + Varenicline Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.
The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor. | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | mHealth MyMAP + Varenicline | Total | mHealth Self-help + Varenicline |
|---|---|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 8.4 | 49.5 years STANDARD_DEVIATION 8.7 | 50.6 years STANDARD_DEVIATION 8.9 |
| Cigarettes smoked per day | 18.5 cigarettes STANDARD_DEVIATION 9.1 | 17.7 cigarettes STANDARD_DEVIATION 7.2 | 16.9 cigarettes STANDARD_DEVIATION 4.5 |
| Prior use of varenicline Never used varenicline | 19 participants | 38 participants | 19 participants |
| Prior use of varenicline Used varenicline previously | 14 participants | 28 participants | 14 participants |
| Race/Ethnicity, Customized Non-white | 3 participants | 5 participants | 2 participants |
| Race/Ethnicity, Customized White | 30 participants | 61 participants | 31 participants |
| Sex: Female, Male Female | 19 Participants | 37 Participants | 18 Participants |
| Sex: Female, Male Male | 14 Participants | 29 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 33 | 30 / 33 |
| serious Total, serious adverse events | 0 / 33 | 1 / 33 |
Outcome results
Primary
Point Prevalence Abstinence
Self-report of no-smoking, even a puff during the last 7 days.
Time frame: 5 month follow-up
Population: Intent to treat analyses with missing cases imputed as smokers.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mHealth Self-help + Varenicline | Point Prevalence Abstinence | 24 Percentage of people not smoking |
| Augmented mHealth Self-help + Varenicline | Point Prevalence Abstinence | 36 Percentage of people not smoking |
Secondary
Number of Days of Varenicline Use
Number of days varenicline was used
Time frame: 5 mo follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mHealth Self-help + Varenicline | Number of Days of Varenicline Use | 39 Mean number of days | Standard Deviation 28.9 |
| Augmented mHealth Self-help + Varenicline | Number of Days of Varenicline Use | 46 Mean number of days | Standard Deviation 31.9 |