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

ABSTRACT: Rheumatoid 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.This 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.This 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.ClinicalTrials.gov, identifier: NCT02901886 . Registered on 10 September 2016. Recruitment status updated on 10th October 2016.

SUBMITTER: Roelsgaard IK

PROVIDER: S-EPMC5706378 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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

Roelsgaard Ida Kristiane IK Thomsen Thordis T Østergaard Mikkel M Christensen Robin R Hetland Merete Lund ML Jacobsen Søren S Andersen Lena L Tønnesen Hanne H Rollefstad Silvia S Semb Anne Grete AG Esbensen Bente Appel BA

Trials 20171128 1

<h4>Background</h4>Rheumatoid 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 randomis ...[more]

PMID: 29183347

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Project description:IntroductionOnline social networks represent a potential mechanism for the dissemination of health interventions including smoking cessation; however, which elements of an intervention determine diffusion between participants is unclear. Diffusion is frequently measured using R, the reproductive rate, which is determined by the duration of use (t), the 'contagiousness' of an intervention (?) and a participant's total contacts (z). We have developed a Facebook 'app' that allows us to enable or disable various components designed to impact the duration of use (expanded content, proactive contact), contagiousness (active and passive sharing) and number of contacts (use by non-smoker supporters). We hypothesised that these elements would be synergistic in their impact on R, while including non-smokers would induce a 'carrier' state allowing the app to bridge clusters of smokers.Methods and analysisThis study is a fractional factorial, randomised control trial of the diffusion of a Facebook application for smoking cessation. Participants recruited through online advertising are randomised to 1 of 12 cells and serve as 'seed' users. All user interactions are tracked, including social interactions with friends. Individuals installing the application that can be traced back to a seed participant are deemed 'descendants' and form the outcome of interest. Analysis will be conducted using Poisson regression, with event count as the outcome and the number of seeds in the cell as the exposure.ResultsThe results will be reported as a baseline R0 for the reference group, and incidence rate ratio for the remainder of predictors.Ethics and disseminationThis study uses an abbreviated consent process designed to minimise barriers to adoption and was deemed to be minimal risk by the Institutional Review Board (IRB). Results will be disseminated through traditional academic literature as well as social media. If feasible, anonymised data and underlying source code are intended to be made available under an open source license.Clinicaltrialsgov registration numberNCT01746472.

Project description:BackgroundRheumatoid arthritis (RA) is the most common type of autoimmune arthritis affecting 0.5-1% of the adult population worldwide. While the primary line of treatment of RA includes pharmacological therapies, people living with the condition often seek non-pharmacological therapies such as diet and exercise in an attempt to attenuate their symptoms. Established, evidence-based dietary guidelines for RA are currently lacking. The MEDRA study aims to explore the effectiveness of implementing, via telehealth, a Mediterranean type diet (MedDiet) compared to a standard healthy diet as per the Healthy Eating Guidelines (HEG) in Ireland in terms of differences in physical function and quality of life in adults with RA living in Ireland.MethodsThe MEDRA study is a parallel, randomised controlled trial delivered through telehealth methods. Forty-four eligible participants who have RA will be randomly allocated to either a MedDiet or HEG group for a 12 weeks intervention period. Primary outcome measures include changes in physical function and quality of life, both of which will be measured using validated questionnaires at baseline, six and twelve weeks. Both intervention arms will attend a total five teleconsultations with a Registered Dietitian (RD). The MedDiet intervention arm focuses on recommendations from the traditional Mediterranean diet and HEG intervention arm will use the dietary recommendations as currently advised in Ireland.DiscussionThis study will provide evidence as to whether dietary treatment of RA can improve physical function and quality of life in a small cohort of participants with RA. The results of the study will be disseminated at national scientific conferences and published in peer-reviewed journals.EthicsThis protocol has been approved by the Education and Health Sciences Research Ethics Committee at the University of Limerick (2020_09_05_EHS) and by the Health Service Executive Mid-Western Regional Hospital Research Ethics Committee (REC Ref 103/19).Trial registrationClinicalTrials.gov NCT04262505. Trial registration date: April 2, 2020.

Project description:IntroductionIntegration of smoking cessation (SC) into lung cancer screening is essential to optimise clinical and cost effectiveness. The most effective way to use this 'teachable moment' is unclear. The Yorkshire Enhanced Stop Smoking study will measure the effectiveness of an SC service integrated within the Yorkshire Lung Screening Trial (YLST) and will test the efficacy of a personalised SC intervention, incorporating incidental findings detected on the low-dose CT scan performed as part of YLST.Methods and analysisUnless explicitly declined, all smokers enrolled in YLST will see an SC practitioner at baseline and receive SC support over 4 weeks comprising behavioural support, pharmacotherapy and/or a commercially available e-cigarette. Eligible smokers will be randomised (1:1 in permuted blocks of random size up to size 6) to receive either an enhanced, personalised SC support package, including CT scan images, or continued standard best practice. Anticipated recruitment is 1040 smokers (January 2019-December 2020). The primary objective is to measure 7-day point prevalent carbon monoxide (CO) validated SC after 3 months. Secondary outcomes include CO validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response) at all follow-up points. A process evaluation will explore under which circumstances and on which groups the intervention works best, test intervention fidelity and theory test the mechanisms of intervention impact.Ethics and disseminationThis study has been approved by the East Midlands-Derby Research Ethics Committee (18/EM/0199) and the Health Research Authority/Health and Care Research Wales. Results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and via the YLST website.Trial registration numbersISRCTN63825779, NCT03750110.

Project description:BackgroundChina has approximately 300 million current smokers, and smoking cessation services are limited. This study aimed to assess the efficacy of a Cognitive Behavioral Theory-based smoking cessation intervention ('WeChat WeQuit') via the most popular social media platform in China, WeChat.MethodsA parallel, single-blind, two-arm randomised controlled trial was conducted via WeChat between March 19, 2020 and November 16, 2022. Chinese-speaking adult smokers (n = 2000) willing to quit within one month were recruited and randomised in a 1:1 ratio. The intervention group (n = 1005) received the 'WeChat WeQuit' program and the control group (n = 955) received control messages for 14 weeks (2-week prequit and 12-week postquit). Participants were followed up to 26 weeks after the quit date. The primary outcome was self-reported continuous smoking abstinence rate, biochemically validated at 26 weeks. The secondary outcomes were self-reported 7-day and continuous abstinence rates at 6 months. All analyses were by intention to treat. The trial is registered at ClinicalTrials.gov (NCT03169686).FindingsBy intention-to-treat analysis, the biochemically verified 26-week continuous abstinence rate was 11.94% in the intervention group and 2.81% in the control group (OR = 4.68, 95% CI: 3.07-7.13, p < 0.0001). The self-reported 7-day abstinence rates ranged from 39.70% at week 1-32.04% at week 26 for the intervention group and 14.17%-11.86% in the control group for weeks 1 and 26, respectively; the self-reported continuous abstinence rates at weeks 1 and 26 ranged from 34.33% to 24.28% and 9.65% to 6.13% in the intervention group and the control group respectively (all p < 0.0001). Participants with low nicotine dependence or previous quit attempts were more likely to successfully quit smoking.InterpretationThe 'WeChat WeQuit' intervention significantly increased smoking abstinence rates at 6 months and should be considered for treatment-seeking smokers in China.FundingThe research is supported by the Natural Science Foundation of Hunan Province (2020JJ4794, YLiao), the K.C. Wong Postdoctoral Fellowship for YLiao to study at King's College London, and China Medical Board (CMB) Open Competition Program (grant no. 15-226, 22-485, YLiao).

Dataset Information

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

Publications

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

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