Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 722
- 试验地点
- 2
- 主要终点
- Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less
研究概览
简要总结
This study addresses an important problem in public health, smoking in diabetics. The morbidity and mortality observed in diabetics is linked to macro and microvascular problems. The consumption of tobacco has a multiplying effect on these vascular problems in diabetics. This study aims to evaluate the effectiveness of an intensive intervention in tobacco addiction in diabetic patients in primary care.
详细描述
Other objectives of the study are:
- To study the effectiveness of an intensive smoking cessation intervention in the evolution of the phases of change, as based on the Prochaska and DiClemente model, in diabetic patients attended in primary care.
- To evaluate the effectiveness of an intensive smoking cessation intervention in the evolution of tabacco consumption in diabetic patients attended in primary care.
- To quantify the time spent in the intensive smoking cessation intervention compared with the usual care in primary care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic patients who are active smokers
- •over the age of 14
- •receive routine care in their respective health center
排除标准
- •patients with communication difficulties (cognitive deterioration, language barrier)
- •patients who normally receive their habitual care in a different health center
- •patients with terminal diseases, psychiatric diseases that are unstable, or with addictions to other substances
- •patients that are already receiving treatment to quit smoking at the time of recruitment
- •patients that are difficult to locate during the study period
- •patients that refuse to participate in the study
研究组 & 干预措施
Usual care
The subjects in the control group will receive the usual care for smoking cessation in diabetic smokers.
Lifestyle Counseling
The intervention is based on lifestyle advice, motivational interviewing and the use of medications, using the Clinical Practice Guidelines of the Catalan Institute of Health. Health professionals in the intervention group receive a training on the abovementioned techniques.
干预措施: Lifestyle Counseling (Behavioral)
结局指标
主要结局
Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less
时间窗: 12 months after initiation of study
次要结局
- Evolution of the phases of change of the Prochaska and DiClemente model(12 months after initiation of the study)
- Number of cigarettes per day(12 months after initiation of the study)
- Total time (minutes) spent in the intensive smoking cessation intervention(12 months after initiation of the study)
研究者
USR Metropolitana Nord
Doctor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina