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Intensive Smoking-cessation Intervention Versus Smoking-cessation Advice in Smear-positive Patients With Pulmonary Tuberculosis

2017年10月12日 更新者:S.K.SHARMA、All India Institute of Medical Sciences, New Delhi

Impact of a Package of Intensive Smoking-cessation Interventions Versus Smoking-cessation Advice on Outcomes in Smear-positive Patients With Pulmonary Tuberculosis; a Randomised Controlled Trial (STB_RCT).

The aim of the study is to determine the impact of a package of smoking-cessation interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes.

Given the lack of objective clinical data/evidence about the impact of smoking-cessation on TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely to be beneficial particularly in patients with TB, this study proposes to determine the impact of an intensive package of smoking-cessation interventions aimed to promote smoking-cessation (counseling plus nicotine replacement therapy, NRT), on patient response to anti-tuberculosis therapy. This is to be compared with the structured counselling for smoking-cessation that is recommended to be routinely provided by health care workers to all patients who are smokers. If the results prove that such a smoking-cessation PI indeed improves outcomes in TB patients, such information would strongly motivate for the institution of more intensive smoking-cessation interventions in TB clinics than is currently being employed for TB patients

調査の概要

状態

完了

条件

詳細な説明

No clinical trials have been done to determine if the cessation of smoking has any influence on outcome in tuberculosis patients. In particular, if smoking cessation leads to a higher rate of sputum culture-conversion at 2 months, TB transmission rates should be reduced. Such targeted smoking-cessation intervention may be more successful than general public education strategies in reducing the spread of TB in high-incidence countries Tuberculosis (TB) . The WHO has estimated that approximately a third of the world's population is infected with Mycobacterium tuberculosis, and approximately 2 million die from TB every year. Tobacco smoking, which is the single most preventable cause of death in the world today, appears to be an important risk factor for TB disease and mortality, especially in countries such as India. The smoking-TB association has major public health implications because in many of the developing countries where there is a high prevalence of TB, smoking is also a common practice. Smoking is widespread, with approximately a third of the global population aged 15 years or above being smokers, but has reached epidemic proportions in countries such as India, China and Russia. For example, in India more than half of the rural male population is estimated to smoke and India accounts for 1.85 million TB cases each year. Therefore in India, as for other developing countries, the co-existence of a high TB and smoking burden is a major health concern, and further underscores the importance of promoting smoking cessation to the general public. In India, studies have shown a strong association between tobacco and TB mortality. An estimated third of male TB deaths in India may be due to smoking. However, there is concern that many of the published studies did not adequately control for bias and confounding (that may have caused spurious associations).

研究の種類

介入

入学 (実際)

800

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • New Delhi、インド、110029
        • All India Institute of Medical Sciences, Ansari Nagar

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • any adult (> 18 years)
  • Recently diagnosed (primary TB/Relapse TB) smear-positive TB patient who self-reports to smoke at least 10 whole cigarettes or bidis (rolled tobacco leaf) per day, every day

Exclusion Criteria:

  • patients will be excluded from recruitment to the study if they fall into any one or more of these exclusion categories:

    • Inability to give consent or < 18 years
    • Patients who self-report to smoke less than 10 whole cigarettes/bidis per day
    • TB patients who have already started anti-tuberculosis therapy for more than 1 week.
    • Patients with known multidrug-resistant TB (or XDR) (information provided by patient or the information is available in the clinic folder).
    • Known HIV-positive patients
    • Contra-indications to NRT (patients with a history of severe cardiovascular disease including arrhythmias, recent myocardial infarction (within the last 6 months), recent cerebrovascular incident (6 months), and/ or history of peripheral vascular disease, phaeochromocytoma, poorly controlled diabetes mellitus, hyperthyroidism, renal/hepatic impairment or gastritis/peptic ulcers). Patients with asthma or depression will also be excluded, as quitting may have an effect on medications used for these conditions. Patients with severe skin disorders (such as psoriasis or eczema) will also be excluded.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Control arm
Control arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along with routine DOTS treatment
アクティブコンパレータ:Intervention arm
Cessation arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along and nicotine replacement therapy(NRT) and routine DOTS treatment
nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks
他の名前:
  • Nicogum 2mg Cipla pharmaceuticals

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
1. Change in TB Score at second month and sixth month
時間枠:Measured at baseline, second month and sixth month.
Composite score for objective and subjective improvement measured at baseline, second month and sixth month
Measured at baseline, second month and sixth month.
Sputum culture conversion
時間枠:Measured at baseline and second month
Sputum culture conversion at second month using solid/liquid culture technique
Measured at baseline and second month

二次結果の測定

結果測定
メジャーの説明
時間枠
Sputum smear conversion
時間枠:Measured at baseline, second week, fourth week, second month and sixth months
Protocol was amended to access sputum conversion weekly up to second month
Measured at baseline, second week, fourth week, second month and sixth months
Mortality at sixth month
時間枠:Sixth month
To determine number of mortality at the end of follow-up
Sixth month
More than 10% weight gain at six months
時間枠:Sixth month
To determine rate of weight gain after completion of treatment
Sixth month
Proportion of subjects in each group that have quit smoking at second month
時間枠:Sixth month
To determine the rate of smoking cessation in the cohort
Sixth month
Treatment completion
時間枠:Six months for new cases and eight months for re-treatment cases following regimen 2
Six months for new cases and eight months for re-treatment cases following regimen 2
Cure, failure and default rate
時間枠:At sixth month
To determine cure, failure and default rate in the cohort
At sixth month

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Surendra K Sharma, MD, Ph.D.、AIIMS, New Delhi

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2010年11月1日

一次修了 (実際)

2016年9月1日

研究の完了 (実際)

2016年9月1日

試験登録日

最初に提出

2011年6月23日

QC基準を満たした最初の提出物

2012年1月20日

最初の投稿 (見積もり)

2012年1月25日

学習記録の更新

投稿された最後の更新 (実際)

2017年10月13日

QC基準を満たした最後の更新が送信されました

2017年10月12日

最終確認日

2017年10月1日

詳しくは

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