Evaluating an Adaptive and Interactive mHealth Smoking Cessation and Medication Adherence Program: A Randomized Pilot Feasibility Study

Jennifer B McClure, Melissa L Anderson, Katharine Bradley, Lawrence C An, Sheryl L Catz, Jennifer B McClure, Melissa L Anderson, Katharine Bradley, Lawrence C An, Sheryl L Catz

Abstract

Background: Mobile health (mHealth) interventions hold great promise for helping smokers quit since these programs can have wide reach and facilitate access to comprehensive, interactive, and adaptive treatment content. However, the feasibility, acceptability, and effectiveness of these programs remain largely untested.

Objective: To assess feasibility and acceptability of the My Mobile Advice Program (MyMAP) smoking cessation program and estimate its effects on smoking cessation and medication adherence to inform future research planning.

Methods: Sixty-six smokers ready to quit were recruited from a large regional health care system and randomized to one of two mHealth programs: (1) standard self-help including psychoeducational materials and guidance how to quit smoking or (2) an adaptive and interactive program consisting of the same standard mHealth self-help content as controls received plus a) real-time, adaptively tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor. Participants in both arms were also prescribed a 12-week course of varenicline. Follow-up assessments were conducted at 2 weeks post-target quit date (TQD), 3 months post-TQD, and 5 months post-TQD. Indices of program feasibility and acceptability included acceptability ratings, utilization metrics including use of each MyMAP program component (self-help content, secure messaging, and adaptively tailored advice), and open-ended feedback from participants. Smoking abstinence and medication adherence were also assessed to estimate effects on these treatment outcomes.

Results: Utilization data indicated the MyMAP program was actively used, with higher mean program log-ins by experimental than control participants (10.6 vs 2.7, P<.001). The majority of experimental respondents thought the MyMAP program could help other people quit smoking (22/24, 92%) and consistently take their stop-smoking medication (17/22, 97%) and would recommend the program to others (20/23, 87%). They also rated the program as convenient, responsive to their needs, and easy to use. Abstinence rates at 5-month follow-up were 36% in the experimental arm versus 24% among controls (odds ratio 1.79 [0.61-5.19], P=.42). Experimental participants used their varenicline an average of 46 days versus 39 among controls (P=.49). More than two-thirds (22/33, 67%) of experimental participants and three-quarters (25/33, 76%) of controls prematurely discontinued their varenicline use (P=.29).

Conclusions: The MyMAP intervention was found to be feasible and acceptable. Since the study was not powered for statistical significance, no conclusions can be drawn about the program's effects on smoking abstinence or medication adherence, but the overall study results suggest further evaluation in a larger randomized trial is warranted.

Clinicaltrial: ClinicalTrials.gov NCT02136498; https://ichgcp.net/clinical-trials-registry/NCT02136498 (Archived by WebCite at http://www.webcitation.org/6jT3UMFLj).

Keywords: eHealth; mHealth; mobile health; secure messaging; smoking; tobacco use cessation; varenicline.

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Enrollment flow.
Figure 2
Figure 2
Self-help quit guide.
Figure 3
Figure 3
MyMAP tailored advice.

References

    1. WHO Report on the Global Tobacco Epidemic, 2015: Raising Taxes on Tobacco. Geneva, Switzerland: World Health Organization; 2015. [2016-07-24]. .
    1. Centers for Disease Control and Prevention Vital signs: current cigarette smoking among adults aged 18 years and older, United States, 2005-2010. MMWR Morb Mortal Wkly Rep. 2011;60(35):1207–1212.
    1. Centers for Disease Control and Prevention Quitting smoking among adults, United States, 2001-2010. MMWR Morb Mortal Wkly Rep. 2011 Nov 11;60(44):1513–1519.
    1. Jamal A, Homa DM, O'Connor E, Babb SD, Caraballo RS, Singh T, Hu SS, King BA. Current cigarette smoking among adults: United States, 2005-2014. MMWR Morb Mortal Wkly Rep. 2015;64(44):1233–1240. doi: 10.15585/mmwr.mm6444a2.
    1. Mobile health (mHealth) for tobacco control. Geneva, Switzerland: World Health Organization; [2016-07-24]. 2014 .
    1. McClure J, Hartzler A, Catz S. Design considerations for smoking cessation apps: feedback from nicotine dependence treatment providers and smokers. JMIR mHealth uHealth. 2016;4(1)
    1. The Smartphone Difference. Washington, DC: Pew Internet and American Life Project; 2015. [2016-07-24]. .
    1. Balmford J, Borland R, Hammond D, Cummings KM. Adherence to and reasons for premature discontinuation from stop-smoking medications: data from the ITC Four-Country Survey. Nicotine Tob Res. 2011 Feb;13(2):94–102. doi: 10.1093/ntr/ntq215.
    1. Pierce JP, Gilpin EA. Impact of over-the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. JAMA. 2002 Sep 11;288(10):1260–1264.
    1. Thorndike AN, Biener L, Rigotti NA. Effect on smoking cessation of switching nicotine replacement therapy to over-the-counter status. Am J Public Health. 2002 Mar;92(3):437–442.
    1. Paul CL, Walsh RA, Girgis A. Nicotine replacement therapy products over the counter: real-life use in the Australian community. Aust N Z J Public Health. 2003 Oct;27(5):491–495.
    1. Catz SL, Jack LM, McClure JB, Javitz HS, Deprey M, Zbikowski SM, McAfee T, Richards J, Swan GE. Adherence to varenicline in the COMPASS smoking cessation intervention trial. Nicotine Tob Res. 2011 May;13(5):361–368. doi: 10.1093/ntr/ntr003.
    1. Blak BT, Wilson K, Metcalfe M, Maguire A, Hards M. Evaluation of varenicline as an aid to smoking cessation in UK general practice - a THIN database study. Curr Med Res Opin. 2010 Apr;26(4):861–870. doi: 10.1185/03007990903526461.
    1. Cooper TV, DeBon MW, Stockton M, Klesges RC, Steenbergh TA, Sherrill-Mittleman D, Jennings LC, Johnson KC. Correlates of adherence with transdermal nicotine. Addict Behav. 2004 Nov;29(8):1565–1578. doi: 10.1016/j.addbeh.2004.02.033.
    1. Alterman AI, Gariti P, Cook TG, Cnaan A. Nicodermal patch adherence and its correlates. Drug Alcohol Depend. 1999 Jan 7;53(2):159–165.
    1. Orleans CT, Resch N, Noll E, Keintz MK, Rimer BK, Brown TV, Snedden TM. Use of transdermal nicotine in a state-level prescription plan for the elderly. A first look at 'real-world' patch users. JAMA. 1994 Feb 23;271(8):601–607.
    1. McLaughlin T, Hogue SL, Stang PE. Once-daily bupropion associated with improved patient adherence compared with twice-daily bupropion in treatment of depression. Am J Ther. 2007;14(2):221–225. doi: 10.1097/01.mjt.0000208273.80496.3f.
    1. Baker TB, Piper ME, Stein JH, Smith SS, Bolt DM, Fraser DL, Fiore MC. Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks: A Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):371–379. doi: 10.1001/jama.2015.19284.
    1. Swan GE, McClure JB, Jack LM, Zbikowski SM, Javitz HS, Catz SL, Deprey M, Richards J, McAfee TA. Behavioral counseling and varenicline treatment for smoking cessation. Am J Prev Med. 2010 May;38(5):482–490. doi: 10.1016/j.amepre.2010.01.024.
    1. DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002 Sep;40(9):794–811. doi: 10.1097/01.MLR.0000024612.61915.2D.
    1. Drovandi AD, Chen CC, Glass BD. Adverse effects cause varenicline discontinuation: A meta-analysis. Curr Drug Saf. 2016;11(1):78–85.
    1. Fiore M, Jaén C, Baker T, Bailey W, Benowitz N, Curry S, Dorfman S, Froelicher E, Goldstein M, Healton C, Henderson P, Heyman R, Koh H, Kottke T, Lando H, Mecklenburg R, Mermelstein R, Mullen P, Orleans C, Robinson L, Stitzer M, Tommasello A, Villejo L, Wewers M. Treating tobacco use and dependence: update. Clinical practice guideline. Rockville, MD: US Department of Health and Human Services Public Health Service; 2008. p. 2008.
    1. Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119–1127.
    1. West R, Hajek P, Stead L, Stapleton J. Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction. 2005 Mar;100(3):299–303. doi: 10.1111/j.1360-0443.2004.00995.x.
    1. Zbikowski SM, Hapgood J, Smucker BS, McAfee T. Phone and web-based tobacco cessation treatment: real-world utilization patterns and outcomes for 11,000 tobacco users. J Med Internet Res. 2008;10(5):e41. doi: 10.2196/jmir.999.
    1. Wu Q, Gilbody S, Peckham E, Brabyn S, Parrott S. Varenicline for smoking cessation and reduction in people with severe mental illnesses: systematic review and meta-analysis. Addiction. 2016 Apr 4; doi: 10.1111/add.13415.
    1. Sterling LH, Windle SB, Filion KB, Touma L, Eisenberg MJ. Varenicline and adverse cardiovascular events: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2016;5(2) doi: 10.1161/JAHA.115.002849.
    1. Cunningham FE, Hur K, Dong D, Miller DR, Zhang R, Wei X, McCarren M, Mosholder AD, Graham DJ, Aspinall SL, Good CB. A comparison of neuropsychiatric adverse events during early treatment with varenicline or a nicotine patch. Addiction. 2016 Jan 30; doi: 10.1111/add.13329.
    1. Smith RC, Amiaz R, Si T, Maayan L, Jin H, Boules S, Sershen H, Li C, Ren J, Liu Y, Youseff M, Lajtha A, Guidotti A, Weiser M, Davis JM. Varenicline effects on smoking, cognition, and psychiatric symptoms in schizophrenia: a double-blind randomized trial. PLoS One. 2016;11(1):e0143490. doi: 10.1371/journal.pone.0143490.
    1. Kotz D, Viechtbauer W, Simpson C, van Schayck OC, West R, Sheikh A. Cardiovascular and neuropsychiatric risks of varenicline: a retrospective cohort study. Lancet Respir Med. 2015 Oct;3(10):761–768. doi: 10.1016/S2213-2600(15)00320-3.
    1. Shewale AR, Borse MS, Brown JD, Li C. Mental health status of varenicline and bupropion users during a quit attempt compared to current smokers, other quitters, and non-smokers. Drug Alcohol Depend. 2015 Sep 1;154:132–138. doi: 10.1016/j.drugalcdep.2015.06.028.
    1. Raich A, Ballbè M, Nieva G, Cano M, Fernández T, Bruguera E, Fernández E. Safety of varenicline for smoking cessation in psychiatric and addicts patients. Subst Use Misuse. 2016 Apr 15;51(5):649–657. doi: 10.3109/10826084.2015.1133646.
    1. Anthenelli R, Benowitz N, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a doubleblind, randomised, placebo-controlled clinical trial. Lancet. 2016:e1–e14.
    1. SRNT Subcommittee on Biochemical Verification Biochemical verification of tobacco use and cessation. Nicotine Tob Res. 2002;4(2):149–159.
    1. Zeng EY, Vilardaga R, Heffner JL, Mull KE, Bricker JB. Predictors of utilization of a novel smoking cessation smartphone app. Telemed J E Health. 2015 Jul 14; doi: 10.1089/tmj.2014.0232.
    1. Buller DB, Borland R, Bettinghaus EP, Shane JH, Zimmerman DE. Randomized trial of a smartphone mobile application compared to text messaging to support smoking cessation. Telemed J E Health. 2014 Mar;20(3):206–214. doi: 10.1089/tmj.2013.0169.
    1. Ubhi HK, Michie S, Kotz D, Wong WC, West R. A mobile app to aid smoking cessation: preliminary evaluation of SmokeFree28. J Med Internet Res. 2015;17(1):e17. doi: 10.2196/jmir.3479.
    1. Bricker JB, Mull KE, Kientz JA, Vilardaga R, Mercer LD, Akioka KJ, Heffner JL. Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy. Drug Alcohol Depend. 2014 Oct 1;143:87–94. doi: 10.1016/j.drugalcdep.2014.07.006.
    1. Ploderer B, Smith W, Pearce J, Borland R. A mobile app offering distractions and tips to cope with cigarette craving: a qualitative study. JMIR Mhealth Uhealth. 2014;2(2):e23. doi: 10.2196/mhealth.3209.
    1. Garrison KA, Pal P, Rojiani R, Dallery J, O'Malley SS, Brewer JA. A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol. BMC Psychiatry. 2015;15:83. doi: 10.1186/s12888-015-0468-z.
    1. Baskerville NB, Struik LL, Hammond D, Guindon GE, Norman CD, Whittaker R, Burns CM, Grindrod KA, Brown KS. Effect of a mobile phone intervention on quitting smoking in a young adult population of smokers: randomized controlled trial study protocol. JMIR Res Protoc. 2015;4(1):e10. doi: 10.2196/resprot.3823.
    1. BinDhim NF, McGeechan K, Trevena L. Assessing the effect of an interactive decision-aid smartphone smoking cessation application (app) on quit rates: a double-blind automated randomised control trial protocol. BMJ Open. 2014;4(7):e005371. doi: 10.1136/bmjopen-2014-005371.
    1. Valdivieso-López E, Flores-Mateo G, Molina-Gómez J, Rey-Reñones C, Barrera UM, Duch J, Valverde A. Efficacy of a mobile application for smoking cessation in young people: study protocol for a clustered, randomized trial. BMC Public Health. 2013;13:704. doi: 10.1186/1471-2458-13-704.
    1. Hassandra M, Lintunen T, Kettunen T, Vanhala M, Toivonen H, Kinnunen K, Heikkinen R. Effectiveness of a Mobile Phone app for adults that uses physical activity as a tool to manage cigarette craving after smoking cessation: a study protocol for a randomized controlled trial. JMIR Res Protoc. 2015;4(4):e125. doi: 10.2196/resprot.4600.
    1. Hoeppner BB, Hoeppner SS, Seaboyer L, Schick MR, Wu GW, Bergman BG, Kelly JF. How smart are smartphone apps for smoking cessation? A content analysis. Nicotine Tob Res. 2015 Jun 4; doi: 10.1093/ntr/ntv117.
    1. Krebs P, Tseng T, Pham H, Wong S, Sherman SE, Shelley D, Furberg RD, Wolfe H. Formative evaluation of a text messaging intervention to promote varenicline adherence among tobacco-dependent persons with HIV. J Health Commun. 2015;20(9):1021–1025. doi: 10.1080/10810730.2015.1018595.

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