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Clinical Trials/CTRI/2024/02/062815
CTRI/2024/02/062815Not yet recruitingNot Applicable

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

East Point College of Medical sciences and research centre.1 site in 1 country300 target enrollmentStarted: February 23, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
smoking cessation- successful

Study Overview

Brief Summary

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

Study Design

Study Type
Observational

Eligibility Criteria

Ages
21.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

  • Smokeless tobacco users
  • Patients on psychotropic drugs.

Outcomes

Primary Outcomes

smoking cessation- successful

Time Frame: Baseline

smoking cessation- failure

Time Frame: Baseline

Secondary Outcomes

  • Trends of smoking in Bangalore(Baseline)

Investigators

Sponsor
East Point College of Medical sciences and research centre.
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Gayathri Devi HJ

East Point College of Medical Sciences and Research Centre

Study Sites (1)

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