Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence - results of a prematurely terminated study

Abstract

Background: Nicotine replacement therapy (NRT) bought over the counter (OTC) appears to be largely ineffective for smoking cessation, which may be partially explained by poor adherence. We developed and evaluated the NRT2Quit smartphone app (for iOS) designed to improve quit attempts with OTC NRT by improving adherence to the medications.Methods: This study was a pragmatic double-blind randomised controlled trial with remote recruitment through leaflets distributed to over 300 UK-based community pharmacies. The study recruited adult daily smokers (≥10 cigarettes per day) who bought NRT, wanted to quit smoking, downloaded NTR2Quit and completed the registration process within the app. Participants were automatically randomly assigned within the app to the intervention (full) version of NRT2Quit or to its control (minimal) versions. The primary outcome was biochemically verified 4-week abstinence assessed at 8-week follow-up using Russell Standard criteria and intention to treat. Bayes factors were calculated for the cessation outcome. Secondary outcomes were self-reported abstinence, NRT use, app use and satisfaction with the app. Results:The study under-recruited. Only 41 participants (3.5% of the target sample) were randomly assigned to NRT2Quit (n = 16) or the control (n = 25) app versions between March 2015 and September 2016. The follow-up rate was 51.2%. The intervention participants had numerically higher biochemically verified quit rates (25.0% versus 8.0%, P = 0.19, odds ratio = 3.83, 0.61-24.02). The calculated Bayes factor, 1.92, showed that the data were insensitive to test for the hypothesis that the intervention app version aided cessation. The intervention participants had higher median logins (2.5 versus 0, P = 0.01) and were more likely to use NRT at follow-up (100.0% versus 28.6%, P = 0.03) and recommend NRT2Quit to others (100.0% versus 28.6%, P = 0.01). Conclusions: Despite very low recruitment, there was preliminary but inconclusive evidence that NRT2Quit may improve short-term abstinence and adherence among smokers using NRT. Well-powered studies on NRT2Quit are needed, but different recruitment methods will be required to engage smokers through community pharmacies or other channels.

A Community Pharmacist-led Smoking Cessation Intervention Using a Smartphone App (PharmQuit): A Randomized Controlled Trial

“…The ndings from other studies using different mobile apps are not consistent. For example, in a study by Herbec et al, carried out in 300 community pharmacies in the UK, the results after 8 weeks showed a quit rate of 25% in the intervention group (using the NRT2Quit app) and 8% in the control group (p = 0.19) [17]. A study by Nomura et al in Japan showed no signi cant difference in continuous abstinence rates between telemedicine counselling plus CureApp and face-to-face clinical visits plus CureApp (81.0% vs 78.9%) [22].…”

“…Current evidence shows bene ts of mobile phone-based smoking cessation interventions on long-term outcomes [16]. A few studies of smoking cessation apps have been conducted in community pharmacies and evaluated for short term (8 weeks) outcomes [17][18].…”

The effectiveness of technology‐based interventions for smoking cessation: An umbrella review and quality assessment of systematic reviews

“…Moreover, Internet or mobile phone-based interventions help in improving adherence to onsite sessions and reduce the chance of premature discontinuation through reminders and short messages [60]. A randomised controlled trial that evaluated the effectiveness of mobile applications providing daily reminders and tips indicated an increase in the rate of adherence to smoking cessation treatments and followups [7].…”

“…daily reminders, daily tips and phone calls) were found to improve adherence to smoking cessation pharmacotherapies. Mobile-based interventions may also incorporate gamifications such as competitions with peers to encourage quit attempt or peer support and incentives [7,8]. Mobile and web-based interventions are becoming an important self-help tool for patient care, with the advent of and improved access to the Internet [9] and recent technological advancements.…”