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临床试验/CTRI/2025/02/080610
CTRI/2025/02/080610尚未招募不适用

Effect of smoking cessation package on health related quality of life among Chronic Obstructive Pulmonary Disease patients attending Bankura Sammilani Medical College and Hospital.

Dr Anirban Nandy1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月25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
120
试验地点
1
主要终点
St. George’s Respiratory Score

研究概览

简要总结

Objectives of Research: To assess the effect of smoking cessation package on health related quality of life among Chronic obstructive pulmonary disease (COPD) patients attending out-patient department of Bankura Sammilani Medical College and Hospital (BSMC&H), Bankura.

Background of Present Study:Chronic obstructive pulmonary disease (COPD) is a major public health challenge in India with significant economic burden and healthcare utilization and contributes to patients’ daily life limitations. Health-related quality of life (HRQoL) reflects the health and disease-related aspects of QoL. Limited studies have examined this dimension in healthcare settings. We will explore the HRQoL among patients with COPD and the influence of smoking cessation package on them. We also tried to elicit other factors (enablers and constraints) influencing it.

Methodology: An analytical interventional study will be conducted among diagnosed COPD patients (on therapy and diagnosed within last 2 years) attending  out-patient department of BSMC, Bankura. After estimating sample size, 120 participants who attended OPD of Bankura Sammilani Medical College and Hospital, Bankura will be selected using systematic sampling satisfying the inclusion and exclusion criteria. The participants will be allocated into two groups. One group will undergo smoking cessation package as an intervention along with usual treatment for COPD, whereas the other group will only get the usual prescribed treatment for COPD. Data will be collected after getting consent from participants via interview and record review. Data will include socio-demographic information, barriers to quit smoking, HRQoL, dependence to smoking, and disease control status. The data will be collected before and after intervention (smoking cessation package) and compared. Collected data will be compiled in Microsoft Excel sheet and analyzed using appropriate statistical methods.

Expected outcome: Whether the magnitude of COPD symptoms leading to poor health related quality of life along with its different correlates may be improved by smoking cessation package is proposed to be explored. It may in turn help to adopt such measures for redressing such adverse circumstances, which may lead to better disease control status and in turn increase the health related quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • COPD patient who are diagnosed in past two years and are on treatment.
  • Smokers (smoking atleast 1 cigarette or bidi per day) for atleast last 5 years.

排除标准

  • Users of other forms of smokeless tobacco.
  • History of asthma, asbestosis, silicosis, bronchiectasis or lung cancer.
  • Mentally retarded or severely ill to respond.

结局指标

主要结局

St. George’s Respiratory Score

时间窗: Baseline and at 6 months

次要结局

  • Fagerström Test for Nicotine Dependence (FTND) Score(Baseline and at 6 months)

研究者

发起方
Dr Anirban Nandy
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Anirban Nandy

Bankura Sammilani Medical College and Hospital

研究点 (1)

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