Telephone-based Motivational Interviewing Delivered by IBD ( Inflammatory Bowel Disease) Nurses for Smoking Cessation in Crohn's Disease: a Randomized Open-label Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 主要终点
- Change from motivation to quit smoking after at one year in the control group and in the experimental group
研究概览
简要总结
Quitting smoking unequivocally improves the course of Crohn's disease (EC), and therefore, it should be one of the main therapeutic targets in the treatment of this disease. The goal of the study was to know the effectiveness of motivational intervention 5 R for smoking cessation in patients with Crohn's disease performed by telephone by nursing, in relation to those who did not receive such intervention.
For this purpose, a controlled, randomized, parallel and open clinical trial was designed. The subjects were patients with Crohn's disease that were actively smoking EC. They were all >18 years old and they had internet access and e-mail. Those who were already in a process of smoking cessation were excluded from the study. Experimental intervention consisted of a motivational intervention for smoking cessation through telephone every 3 months for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Smokers Crohn's disease patients
排除标准
- •Smokers Crohn's disease patients who are receiving treatment of tobacco cessation at the time of inclusion
- •Do not have email
结局指标
主要结局
Change from motivation to quit smoking after at one year in the control group and in the experimental group
时间窗: We measure it at baseline and through study completion, 1 year after
Test de Richmond: to measure the motivation to quit smoking. It consists of 4 questions, scores from 0 to 10, highest score, highest motivation. It provides three categories, low motivation \<4 points, medium motivation 5-6 and high motivation ≥7
Change from stages of changes to quit smoking after at one year in the control group and in the experimental group
时间窗: We measure it at baseline and through study completion, 1 year after
Stages of changes form Prochaska / DiClemente. Transtheoretical model of change consists of 4 mutually exclusive questions and has a legend where it classifies patients according to the state of the wheel of change in which they are: pre-contemplation, preparation, action, maintenance, consolidation and relapse.
次要结局
- Number of patients with Crohn's disease who quit smoking at the end of the study in the control group and in the experimental group.(We measure it at baseline and through study completion, 1 year after)