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临床试验/NCT04864327
NCT04864327已完成不适用

The Effectiveness of a Tobacco Cessation Intervention Program Among Patients With Diabetes at Penang Hospital: a Randomised Controlled Trial

Kansaa A.Ibrahim2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2011年5月5日最近更新:
适应症

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

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

发起方
Kansaa A.Ibrahim
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Kansaa A.Ibrahim

Principal Investigator

Ministry of Health, Malaysia

研究点 (2)

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