Evaluation of a Reinforcement Program Using Text Messages Through Mobile Phone in Smoking Cessation Programs in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Coximetry test (positive/negative)
研究概览
简要总结
Smoking remains a major risk factor for chronic diseases and is a real problem for health systems. The use of emerging technologies, such as mobile phone , may have a important role in smoking cessation programs through sending reinforcement messages when patients quits smoking.
Main objective: To evaluate the effectiveness of a combined 6 months smoking cessation program including health advice provided by a doctor and sending support messages to mobile phone of patients.
Methods: Study design: Randomized single blind clinical trial. Study population: Patients over 18 who are willing to start a smoking cessation program, who have mobile phone, who are able to receive and send messages, and who have a score greater than 5 or equal to 5 on the Richmond scale.
Sample size: 160 patients per arm to detect a difference in the percentage of smoking cessation than 10% (14.9% vs. 4.9%) between the two groups. Intervention: Experimental group: Health advice and support messages to mobile phone patients.
Control group: Health advice. Assessment of the primary endpoint: At 6 months (positive/negative coximetry test).
Statistical analysis: The analysis of the primary endpoint (positive / negative coximetry test) will be performed using logistic regression.
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
- 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
- •Over 18 years.
- •Current smoker (25): Current smoker is defined as the person who at the time of the study beginning declares that smoked daily or occasionally.
- •Possessing mobile phone.
- •Able to receive and send messages through mobile phone.
- •Score greater than 5 or equal to 5 on the Richmond scale
排除标准
- •People with a history of mental and behavioral disorders.
- •Patients with a diagnosis of depression using the depression subscale of Goldberg (two or more positive responses).
- •Patients who with pharmacological therapy for smoking cessation or who require it throughout the study.
- •Pregnant women.
结局指标
主要结局
Coximetry test (positive/negative)
时间窗: at 6 months
次要结局
- Number of messages requested by the patient anxiety.(at 12 months)
- -Prevalence abstinence at the 4th week self-reported by the patient: Yes / No.(At 4th week)
- Number of messages relapse-slip timely requested by the patient.(At 12 months)
- slip: Yes / No.(at 12 months)
- -Outcome of coxymetry test at 12 months of start: Positive / Negative.(at 12 months)
- - Relapse: Yes / No.(At 12 months)
- Continuous abstinence at 6 months: Yes / No(At 6 months)
- Abstinence point during the first 7 days self-reported by the patient: Yes / No.(at first week)
- -Prevalence abstinence at 12th week self-reported by the patient: Yes / No.(At 12th week)
研究者
Raquel Cobos Campos
pharmaceutical
Basque Health Service