The Effectiveness of a Tobacco Cessation Intervention Program Among Patients With Diabetes at Penang Hospital: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- quitting rate
研究概览
简要总结
This study determined the prevalence of tobacco smoking among patients with diabetes and evaluated the impact of a diabetes-specific tobacco cessation intervention on tobacco cessation outcomes and on the glycaemic control, blood pressure, lipid profile, complications, comorbidities and number of cigarettes consumed per day among the patients.
详细描述
The intervention protocol
Study Design and Study Population
This study is a randomized controlled trial involving diabetic patients who smoke tobacco, attending the diabetes clinic at Penang General Hospital in Malaysia. The prevalence of smoking among patients with diabetes will be measured by reviewing the patient who visit the Endocrine department within three months. The minimum sample size needed for calculating the prevalence estimated by using the equation below:
(Lwanga, S. K. and Lemeshow, S., 1991; Daniel, W. W., 1999; Cochran, W., 1977) n=(z^2 p (1-p))/d^2
Where n = the sample size; Z = the statistic for the 95% level of confidence used in the power analyses, which was 1.96; p = the expected prevalence or the proportion used, which was 0.5; and d = the precision used, which was 0.05. The estimated minimum sample size for the prevalence is 348 patients. One thousand one hundred eighteen medical records reviewed to find out the prevalence of smoking among the diabetic patients at the diabetes department in Penang General Hospital. Among those 1118 diabetic patients there were 108 smoking diabetic patients, depending on that; the prevalence of smoking among patients with diabetes will be 9.66%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a diagnosis of diabetes mellitus.
- •Currently smoking tobacco.
- •Speak English and/or Malay.
排除标准
- •Do not have diabetes mellitus.
- •Do not smoke tobacco or ex-smokers. do not speak English or Malay
结局指标
主要结局
quitting rate
时间窗: 12 months
stop smoking
HbA1c
时间窗: 12 months
glucose level
次要结局
- TriGlycerides, Low Density Lipoprotien, High Density Lipoprotien(12 MONTHS)
- BP(systolic and diastolic blood pressure)(12 MONTHS)
研究者
Kansaa A.Ibrahim
Principal Investigator
Ministry of Health, Malaysia
