Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation and Physical and Mental Health in Patients With Coronary Heart Disease: Application of the Transtheoretical Model
试验速览
- 阶段
- 不适用
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Stage3-The change of smoking cessation success rate
研究概览
简要总结
The purpose of the study is to adopt the Trans-theoretical Model to facilitate step-by-step changes in a patient's smoking behavior and explore the effect of "Cognitive-Behavioral Education Course" and "Exercise Program" on Smoking cessation, physical health, and mental health of smokers with CAD.
详细描述
Smoking is a major risk factor of coronary artery disease (CAD) and is responsible for the death of one in three patients with cardiovascular diseases. Smoking cessation is one of the most favorable methods for reducing the risk of cardiovascular diseases; even for patients with a heart disease, quitting smoking can reduce the chance of a relapse of said disease. However, the Health Promotion Administration revealed that among male patients with acute myocardial infarction (AMI), 79.5% had smoked and 35.6% continued to smoke after an episode of AMI. Although previous studies confirmed that health education and exercises can increase smoking cessation rates, patients' lack of motivation to quit smoking has resulted in a failure rate of 65.5%. Therefore, identifying methods to strengthen patients' motivation to quit smoking is a key to successfully achieving smoking cessation.
The purpose of the study is to adopt the Trans-theoretical Model to facilitate step-by-step changes in a patient's smoking behavior and explore the effect of "Cognitive-Behavioral Education Course" and "Exercise Program" on Smoking cessation, physical health, and mental health of smokers with CAD. This study is composed of three stages in three years period, recruiting patients (who meet the selection criteria) from the cardiology department of a medical center in northern Taiwan. For the first stage, a cross-sectional method will be employed to investigate the relationship between smoking status and various physiological and psychological indicators in patients with CAD. For the second stage, subjects who are at the smoking cessation stage of "precontemplation" and "contemplation" will be recruited.
A quasi-experimental design will be used to determine the effects of a four-week cognitive-behavioral education course related to smoking cessation on the participants' smoking cessation behavior, smoking decision-making, and self-efficacy in smoking cessation. For the third stage, subjects from Stages 1 and 2 who are at the "preparation " and "action" stage will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status. The primary indicator used for health status evaluation is smoking cessation success rate; the secondary indicators used are physiological status (i.e., nicotine addiction, lung carbon monoxide concentration, heart rate variability, and smoking withdrawal syndrome) and psychological status (i.e., depression and resilience). SPSS for Window 24.0 software will be used in statistical analysis. The type one error is 0.05. In inferences analysis, chi-square test, Pearson correlation coefficient, independent t test, one-way ANOVA and post hoc comparison (scheffe) test will be used to examine the variance among groups. Finally, ANCOVA and GEE mode will be used to test the effectiveness of intervention at stage 1 and stage 2, respectively.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who meet the diagnosis and can perform aerobic exercise after being referred by a physician.
- •Those who have a clear consciousness and have no mental disorders as recorded in medical records or verbally.
- •Those who can walk on their own.
- •Participated in the first or second phase of the study and the smoking cessation phase is in the preparation and action phases
排除标准
- •Irregular heart rhythm.
- •Install a heart regulator.
- •Those who already have regular exercise (3 times a week, 20-30 minutes of physical activity each time).
结局指标
主要结局
Stage3-The change of smoking cessation success rate
时间窗: 12-weeks, three-month, and six month
smoking cessation success
Stage2-The change of smoking cessation behavior
时间窗: Before, 4-weeks.
Only one question, "Are you currently considering quitting smoking?" The smoking cessation behavior change stage is divided into 5 periods according to the cross-theoretical model, and they are respectively 1. Unintentional period: current smoking, and no smoking cessation will be considered in the next six months. 2. Intent period: currently smoking, but considering quitting in the next six months. 3. Preparation period: currently smoking, and plan to quit smoking within the nearest month. 4. Action period: I have quit smoking, but less than six months. 5. Maintenance period: I have quit smoking for more than six months.
次要结局
- Stage3-The change of smoking withdrawal syndrome(12-weeks, three-month, and six month)
- Stage3-The change of Fagerstrom Test for Nicotine Dependence (FTND)(12-weeks, three-month, and six month)
- Stage3-The change of lung carbon monoxide concentration(12-weeks, three-month, and six month)
- Stage3-The change of the Center for Epidemiological Studies -Depression Scales (CESD-10)(12-weeks, three-month, and six month)
- Stage3-The change of Taiwanese Version of the Brief Resilience Scale(12-weeks, three-month, and six month)
- Stage2- self-efficacy in smoking cessation(Before, 4-weeks.)
- Stage3-The change of heart rate variability(12-weeks, three-month, and six month)
- Stage2- smoking decision-making(Before, 4-weeks.)