Adaptive interventions to optimise the mobile phone-based smoking cessation support: study protocol for a sequential, multiple assignment, randomised trial (SMART)

Abstract

Background: Mobile health (mHealth) is promising in developing personalised smoking cessation interventions. By using an adaptive trial design, we aim to evaluate the effectiveness of personalised mHealth intervention in increasing smoking cessation. Methods: This study is a two-arm, parallel, accessor-blinded Sequential Multiple-Assignment Randomised Trial (SMART) that randomises 1200 daily cigarette smokers from 70 community sites at two timepoints. In the first phase, participants receive brief cessation advice plus referral assistance to smoking cessation services and are randomly allocated to receive personalised instant messaging (PIM) or regular instant messaging (RIM). In the second phase, PIM participants who are non-responders (i.e. still smoking at 1 month) are randomised to receive either optional combined interventions (multi-media messages, nicotine replacement therapy sampling, financial incentive for active referral, phone counselling, and family/peer support group chat) or continued-PIM. Non-responders in the RIM group are randomised to receive PIM or continued-RIM. Participants who self-report quitting smoking for 7 days or longer at 1 month (responders) in both groups continue to receive the intervention assigned in phase 1. The primary outcomes are biochemical abstinence validated by exhaled carbon monoxide (< 4 ppm) and salivary cotinine (< 10 ng/ml) at 3 and 6 months from treatment initiation. Intention-to-treat analysis will be adopted. Discussion: This is the first study using a SMART design to evaluate the effect of adaptive mHealth intervention on abstinence in community-recruited daily smokers. If found effective, the proposed intervention will inform the development of adaptive smoking cessation treatment and benefits smokers non-responding to low-intensity mHealth support. Trial registration: ClinicalTrials.govNCT03992742. Registered on 20 June 2019.