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临床试验/CTRI/2024/02/062815
CTRI/2024/02/062815尚未招募不适用

"Smoking cessation- A prospective longitudinal study of healthcare challenges at a tertiary care centre".

East Point College of Medical sciences and research centre.1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年2月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
smoking cessation- successful

研究概览

简要总结

Need for the study: There is paucity of data regarding smoking cessation practices in the Indian literature. Our study aims at analysing the challenges in implementing smoking cessation strategies and development of skills that can be used by healthcare providers to facilitate health promoting behaviours among their patients.

Aims & Objectives of the study

• To assess knowledge, attitude & practices about smoking cessation among smokers visiting our institution.

• To identify the challenges and the barriers in the implementation of smoking cessation programme among patients visiting our institution

• Materials & Methods

• Study design: A cross-sectional study, single center

• Study setting: Patients presenting to Respiratory medicine department at East Point College of Medical Sciences & Research Center

• Study duration:6 months

• Period needed for collecting the data – 6 months

• Period needed for tabulating the data – 1 month

• Period needed for analysing the data – 1 month

• Study population – 300

Inclusion criteria

  • Out-patients and in-patients who are current smokers, presenting to Respiratory medicine department aged 21 years and above

  • Agreeing to participate

Exclusion criteria: Smokeless tobacco users

Patients on psychotropic drugs

Study tools & Techniques:

Questionnaire based Methodology:

  1. All patients with smoking history and providing informed consent will be recruited in the study.

  2. Demographic data shall be recorded.

  3. Detailed clinical history of the patient with the comorbidities will be collected.

  4. Questionnaire annexure attached (KAP)

  5. Any abnormality on general physical examination and systemic examination will be noted

  6. For those who are willing to quit, behaviour counselling will be done by psychiatry department and followed up for one month

  7. ECG for those willing to quit smoking and need nicotine replacement therapy

  8. The data will be collected in MS-EXCEL SHEET and will be subjected to statistical analysis.

Biological material required: None

Investigations: ECG

Budget & Funding - None

Sample Size: Sample size was estimated by using the proportion of subjects attempted to quit smoking in past was 89.4% from the study by Aiswaraya vijayakrishna et al. using the formula Sample Size = Z1-α /2 2 P (1-P) d 2 Z1-α /2 = is standard normal variate ( at 5% type 1 error (P<0.05) it is 1.96 and at 1% type1 error(P<0.01) it is 2.58). As in majority of studies P values are considered significant below 0.05 hence 1.96 is used in formula. P= Expected proportion in population based on previous studies or pilot studies d= Absolute error or precision P = 89.4% or 0.138 q = 10.6% or 0.8612 d = 5% or 0.05 Using the above values at 95% Confidence level a sample size is approximately 146. But we would like increase our sample size to 300.

Statistical Methods Data will be entered into Microsoft excel data sheet and will be analyzed using SPSS 22 version software.

Categorical data will be represented in the form of Frequencies and proportions.

Chi-square will be used as test of significance. Continuous data will be represented as mean and standard deviation. Independent t test will be used as test of significance to identify the mean difference. P value <0.05 will be considered as statistically significant.

Conclusion

Our study will allow for a better understanding of the factors for motivation and adherence to treatment of smoking cessation. Based on the results, smoking cessation interventions can be developed according to the socio-economic demographics of the region. Our study results will help us to implement strategies to motivate the patients to quit smoking at our center.

Limitation - Single centred study

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Out-patients and in-patients who are current smokers, presenting to Respiratory medicine department aged 21 years and above 2.Agreeing to participate.

排除标准

  • Smokeless tobacco users
  • Patients on psychotropic drugs.

结局指标

主要结局

smoking cessation- successful

时间窗: Baseline

smoking cessation- failure

时间窗: Baseline

次要结局

  • Trends of smoking in Bangalore(Baseline)

研究者

发起方
East Point College of Medical sciences and research centre.
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Gayathri Devi HJ

East Point College of Medical Sciences and Research Centre

研究点 (1)

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