REU-stop - Effect of Intensive Smoking Cessation Intervention on Smoking Cessation and Disease Activity in Patients With Rheumatoid Arthritis.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- EULAR clinical response (an improvement in DAS28 of >0.6) at 3 months follow-up
研究概览
简要总结
This study aims to test the effect of an intensive smoking cessation intervention (motivational counseling combined with nicotine replacement) on smoking cessation and disease activity in patients with Rheumatoid Arthritis (RA). Half of the patients will participate in a smoking cessation intervention; the other half will receive usual treatment.
详细描述
Tobacco smoking is a well-known environmental risk factor for developing rheumatoid arthritis (RA). The onset of RA can occur in all age groups, with the majority being women aged 50-60 years. RA is a chronic inflammatory disease and cannot be cured. However, the activity of the disease can be reduced by medication. During periods with high disease activity, patients experience increased pain and fatigue and subsequent restrictions in social life, psychical activity and activities of daily life. Furthermore, the inflammatory process underlying RA can cause pain, fatigue, reduced health-related quality of life and reduced physical function. Patients with RA are at increased risk of cardiovascular diseases similar to the risk demonstrated in patients with diabetes. Furthermore, several studies indicate that smokers with inflammatory arthritis tend to experience more pain and fatigue, and a reduced quality of life compared to non-smokers.
Aim: This randomized 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.
Material and Methods Trial design: The trial is an international, multicentre, randomized RCT in which daily smokers with RA in remission or with low-moderate disease activity ≤ 5.1 DAS28 (Disease Activity Score - based on 28 joints assessment, serum-C-reactive protein (CRP) and patient's Global assessment of a visual analogue scale (VAS)) will be randomized 1:1 to either an intervention group or to a control group. Patients will be followed for 58 weeks, including the 6-week intervention period and 3 months, 6 months and 12 months into the post-intervention follow-up period.
Study setting: We will recruit patients from the Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark and from the Preventive Cardio-Rheuma Clinic, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Randomization and blinding: Immediately after collecting baseline data using stratified block randomization (block size 6-10) participants will be randomized to either 1) the intervention group or 2) the control group. The stratification variables are trial site and Anti-cyclic citrullinated peptide (Anti-CCP status). The allocation sequence is generated using computer-generated random numbers. Participants will be informed about their group allocation directly after randomization. For participants randomized to the smoking cessation intervention group, the first intervention meeting will be scheduled as soon as possible, preferably immediately after randomization. It is not possible either to blind participants to their allocated intervention or to blind the project nurses performing the intervention. The primary outcomes will be assessed by blinded assessors and smoking cessation will be self-reported by participants and validated biochemically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in the study if they have RA as defined by the American College of Rheumatology (ACR) 1987 criteria and/or European League Against Rheumatism (EULAR) 2010 criteria (32, 33), >18 years of age, smoking tobacco daily, are able to understand and speak Danish or Norwegian, respectively. Furthermore, patients need to for the past three months to have been in clinical remission or low-moderate disease activity (DAS28 ≤ 5.1) and in stable anti-rheumatic medical treatment as documented in 1) the DANBIO registry in Denmark, or 2) the electronic patient journal, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
排除标准
- •Patients will be excluded from the study if they have had a change of dose or preparation in anti-rheumatic medical treatment within the previous 3 months, or a scheduled change in anti-rheumatic medical treatment, including glucocorticoid injection during the previous month, are cognitively or otherwise unable to give informed consent, are pregnant or breastfeeding.
- •Excluded patients, and eligible patients who do not want to participate, will be registered in one of the following three categories 1) not meeting the inclusion criteria 2) refused to participate 3) other reasons.
结局指标
主要结局
EULAR clinical response (an improvement in DAS28 of >0.6) at 3 months follow-up
时间窗: 3 months post-intervention
The recommended EULAR clinical response in relation to disease activity will be assessed using DAS28 at 3 months post-intervention. The DAS28 score consists of four elements; CRP, number of swollen joints, number of painful joints (maximum 28) and a Global General Health VAS score. The joint count and Global General Health are assessed by both the participant and a project nurse blinded to group allocation
Self-reported continuous smoking cessation validated by exhaled carbon-monoxide at 3 months follow-up
时间窗: 3 months post-intervention
The participants' smoking status will be monitored by self-reported continuous smoking cessation validated by exhaled carbon monoxide (CO) in breath (CO-Check, NEOMED GmbH; Germany). Carbon monoxide values \> 10 parts per million (ppm) indicate tobacco smoking
次要结局
- HbA1c(3, 6 and 12 months post-intervention)
- EULAR repsonse at 6 and 12 months post-intervention(6 and 12 months post-intervention)
- Disease activity measured by DAS28 at 3, 6 and 12 months post-intervention(3, 6 and 12 months post-intervention)
- Self-reported smoking status at 6 and 12 months post-intervention(6 and 12 months post-intervention)
- Blood pressure and pulse(3, 6 and 12 months post-intervention)
- Serum lipids(3, 6 and 12 months post-intervention)
- Change in number of swollen and tender joints at 3, 6 and 12 months post-intervention(3, 6 an 12 months post-intervention)
- Physician and patient Global VAS(3, 6 and 12 months post-intervention)
- C-reactive protein (CRP)(3, 6 and 12 months post-intervention)
- Patient assessed disease activity by the FLARE Instrument(3, 6 and 12 months post-intervention)
- Arterial stiffness(3, 6 and 12 months post-intervention)
- Waist circumference(3, 6 and 12 months post-intervention)
- Lung function(3, 6 and 12 months post-intervention)
- Body weight(3, 6 and 12 months post-intervention)
- Physical function(3, 6 and 12 months post-intervention)
- Health-related quality of life(3, 6 and 12 months post-intervention)
- Pain Pain(3, 6 and 12 months post-intervention)
- Fatigue(3, 6 and 12 months post-intervention)
研究者
Bente Appel Esbensen
Senior Researcher, Associate professor
Glostrup University Hospital, Copenhagen