The effect of an intensive smoking cessation intervention on disease activity in patients with rheumatoid arthritis: study protocol for a randomised controlled trial

Abstract

BackgroundRheumatoid arthritis (RA) is a chronic, inflammatory rheumatic disease with the potential to induce significant disability. Patients with RA are at increased risk of cardiovascular diseases (CVD). Smokers with RA tend to experience more pain and fatigue, higher disease activity, more erosive joint destruction and a lower health-related quality of life (HR-QoL) than non-smokers. It remains to be determined whether these effects can be reduced by smoking cessation.This randomised controlled trial (RCT) in patients with RA aims to examine the effect of intensive smoking cessation intervention (motivational counselling combined with tailored nicotine replacement therapy) versus standard care on smoking cessation, and consequently on disease activity. Secondary objectives are to explore the effect on flare, risk factors for CVD, lung function, physical function, HR-QoL, pain and fatigue in patients with RA.MethodsThis will be a multicentre, open label, two arm, parallel group, RCT, including 150 daily smokers with RA, being in remission or having low-moderate disease activity (DAS28 ≤ 5.1). The intervention group (n = 75) will receive five counselling sessions with a trained smoking cessation counsellor based on the principles of motivational counselling. Furthermore, intervention patients will be offered nicotine replacement therapy tailored to individual needs. Participants randomised to the control group will receive standard care. The co-primary outcome is a hierarchical endpoint, which will be evaluated at 3 months follow-up and will include (1) self-reported smoking cessation biochemically validated by exhaled carbon monoxide and (2) achievement of EULAR clinical response (an improvement in DAS28 of > 0.6). Follow-up visits will be performed at 3, 6 and 12 months post-intervention.DiscussionThis trial will reveal whether intensive smoking cessation counselling helps smokers with RA to achieve continuous smoking cessation and whether, as a concomitant benefit, it will reduce their RA disease activity. The trial aims to generate high quality evidence for the feasibility of a health promotion intervention for smokers with RA.Trial registrationClinicalTrials.gov, identifier: NCT02901886. Registered on 10 September 2016. Recruitment status updated on 10th October 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2309-5) contains supplementary material, which is available to authorized users.

How do people with rheumatoid arthritis experience participation in a smoking cessation trial: a qualitative study

“…Participating in the intervention was considered to be a positive and motivational experience, because of the motivation generated with the smoking cessation counsellor and because carbon monoxide levels were monitored. The intervention in the RCT study (Roelsgaard et al, 2017) aimed to help people identify possible barriers to smoking cessation, and explore and overcome these barriers by focusing on something positive through motivational interviewing (MI) (Miller, 2002). Motivational is the keyword in MI, the concept on which the counselling sessions were based.…”

“…This study employed a descriptive qualitative design involving people with RA who had participated in an international RCT, that tested the effect of an intensive smoking cessation intervention on smoking cessation and disease activity in smokers with RA (NCT02901886) (Roelsgaard et al, 2017). The intervention arm consisted of a smoking cessation intervention with five smoking cessation counselling sessions combined with free NRT for six weeks.…”

“…Currently we are carring out a randomized controlled trial (RCT) testing the effect of an intensive smoking cessation intervention on smoking cessation and disease activity in people with RA (Roelsgaard et al, 2017). The intervention consists of behavioural support and NRT to current smokers with RA (Roelsgaard et al, 2017). We wished to evaluate how participants experienced the intervention provided in the RCT and the experiences of smoking cessation.…”

Smoking cessation is associated with lower disease activity and predicts cardiovascular risk reduction in rheumatoid arthritis patients

“…Still, it is currently advised that rheumatology health professionals encourage smoking cessation in RA patients [ 12 , 13 , 41 ]. To our knowledge there is only one published pilot study and one ongoing randomized controlled trial on smoking cessation in patients with RA [ 42 , 43 ].…”

Smoking as a Preventable Risk Factor for Rheumatoid Arthritis: Rationale for Smoking Cessation Treatment in Patients with Rheumatoid Arthritis

“…A recent ongoing randomized controlled trial protocol will examine whether intensive smoking cessation intervention may help smokers with RA to achieve continuous smoking cessation and, secondly, to reduce RA disease activity [66]. The intervention includes individual motivational counselling in combination with tailored NRT.…”