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Effectiveness of Negotiating Self-determination to Reduce Cigarette Consumption

2020年11月2日 更新者:The University of Hong Kong

The Effectiveness of Negotiating Self-Determination to Reduce Cigarette Consumption (NSD-RCC) Among Smokers Attending Outpatient Clinics: A Cluster Randomized Controlled Trial

Background: Smokers attended to outpatient clinics present an excellent 'teachable moment' for smoking cessation interventions. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of negotiating self-determination to reduce cigarette consumption among smokers attending outpatient clinics

Methods: A randomized controlled trial will be conducted in 10 out-patient clinics in Hong Kong. Subjects in the intervention group will receive a brief intervention on smoking reduction plus a smoking reduction leaflet. Additionally, subjects will be asked to think about a smoking reduction schedule for themselves after the negotiation with the counsellor. Subjects in the control group will receive a brief advice on quitting plus a leaflet on smoking cessation. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted. The primary outcome measure is biochemically validated abstinence at 6 months. Secondary outcomes are: (i) biochemically validated abstinence at 12 months, (ii) self-reported 7-day point prevalence of abstinence at 6 and 12 months, (iii) self-reported reduction of ≥ 50% in cigarette consumption at 6 and 12 months, and (iv) self-efficacy against tobacco at 6 and 12 months.

調査の概要

状態

まだ募集していません

条件

詳細な説明

This study aims to test the effectiveness of negotiating self-determination to reduce cigarette consumption (NSD-RCC) among smokers attending outpatient clinics.

Intervention Group (QP) Subjects in this group will receive a brief intervention on smoking reduction with a warning message plus a smoking reduction leaflet (the content will include a roadmap of smoking reduction strategy and information on how to cope with nicotine withdrawal symptoms). The whole intervention will last about 1 minute or slightly longer if necessary. In addition, subjects will be asked to think about a tailored smoking reduction schedule for themselves after the negotiation with the trained counsellor. For the subsequent telephone follow up in the intervention group, information on reduction and cessation will be collected, followed by a "booster" intervention, which will repeat the health warning to positively encourage them to reinforce their efforts and the next reduction target.

Control Group (QI) Subjects in the QI group will always be advised to quit immediately rather than to quit progressively. Subjects will receive a brief advice on quitting with a warning message similar to subjects in the QP group. In addition, subjects will receive a self-help quitting pamphlet published by the Hong Kong Council on Smoking and Health (COSH). Unlike the QP group, subjects in the QI group will not receive smoking reduction intervention and leaflet, and "booster" intervention during telephone follow-ups. However, they will undergo a similar schedule of telephone follow-up as those in the QP group.

Data collection

After completing the baseline questionnaire, subjects will receive proposed intervention according to their group assignment. Four consecutive follow-ups (at 1, 3, 6 and 12 months) will be conducted over the telephone by trained interviewers. Interviewers will first carry out outcome assessments with blinding to group status. Then, the group status will be disclosed so that the intervention group will receive the booster intervention and the control group will not. Smokers who have successfully quit smoking at 6-month will be invited to come back to the out-patient clinic and have biochemical validation tests (saliva cotinine test and exhaled CO test).

Analysis Data analysis will be performed using the Statistical Package for Social Science. We will compare the baseline characteristics of the participants by chi-square test for categorical variables and F-test for continuous variables between the intervention and the control group. We shall use the chi-square test to assess the effect of intervention and calculate the crude odds ratio (OR) with 95% confidence interval (CI) for the primary and secondary outcomes. Those who are lost to follow-up or refuse to participate in the validation tests, will be treated as smokers with no reduction in cigarette consumption compared with (a) baseline, as the main analysis (by intention to treat), (b) the most recent level and (c) complete case (per protocol) analysis by excluding subjects with missing data as a sensitivity analysis.

研究の種類

介入

入学 (予想される)

1566

段階

  • 適用できない

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。

研究連絡先

  • 名前:William, Ho Cheung LI, PhD
  • 電話番号:39176634
  • メール:william3@hku.hk

研究連絡先のバックアップ

  • 名前:Ka Yan, HO Ho, MPhil
  • 電話番号:39176328
  • メール:devilbb@hku.hk

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年歳以上 (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:

smokers

  • who are Chinese
  • aged 18 years or above
  • who smoke at least two cigarettes per day
  • with moderate to severe nicotine dependence, and
  • have no intention to quit smoking ≤7 days, but are interested in reducing the number of cigarettes smoked per day .

Exclusion Criteria:

smokers

  • with unstable medical conditions as advised by the doctor in charge,
  • with poor cognitive state or mental illness,
  • who participate in other smoking cessation programmes or services,
  • with mild nicotine dependence, or
  • who claim that they can quit ≤7 days

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:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Smoking reduction
Subjects will receive a brief intervention on smoking reduction with a warning message plus a smoking reduction leaflet. They will be asked to think about a tailored smoking reduction schedule for themselves after the negotiation with the trained counsellor. The trained counsellor will negotiate a schedule with subjects to reduce their smoking over an acceptable level. For the subsequent telephone follow up in the intervention group, information on reduction and cessation will be collected, followed by a "booster" intervention, which will repeat the health warning to positively encourage them to reinforce their efforts and the next reduction target. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted over the telephone by trained interviewers.
A brief intervention on smoking reduction plus a smoking reduction leaflet
プラセボコンパレーター:Smoking Cessation
Subjects in the QI group will always be advised to quit immediately rather than to quit progressively. Subjects will receive a brief advice on quitting with a warning message similar to subjects in the QP group. In addition, subjects will receive a self-help quitting pamphlet published by the Hong Kong Council on Smoking and Health (COSH). Unlike the QP group, subjects in the QI group will not receive smoking reduction intervention and leaflet, and "booster" intervention during telephone follow-ups. However, they will undergo a similar schedule of telephone follow-up as those in the QP group.
A brief advice on quitting plus a leaflet on smoking cessation

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
時間枠
biochemically validated abstinence using exhaled CO test
時間枠:6 months
6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
呼気一酸化炭素検査を使用して生化学的に検証された禁欲
時間枠:12ヶ月
12ヶ月
自己申告による禁酒の 7 日間ポイントの有病率
時間枠:6ヵ月
6ヵ月
自己申告による禁酒の 7 日間ポイントの有病率
時間枠:12ヶ月
12ヶ月
たばこの消費量が50%以上減少したと自己申告
時間枠:6ヵ月
6ヵ月
たばこの消費量が50%以上減少したと自己申告
時間枠:12ヶ月
12ヶ月
self-efficacy against tobacco
時間枠:6 months
Subjects' self-efficacy against tobacco was assessed by using 12-item Smoking Self-efficacy Questionnaire (SEQ-12). SEQ-12 is a valid and reliable scale, which has been used in both research and clinical setting.
6 months
self-efficacy against tobacco
時間枠:12 months
Subjects' self-efficacy against tobacco was assessed by using 12-item Smoking Self-efficacy Questionnaire (SEQ-12). SEQ-12 is a valid and reliable scale, which has been used in both research and clinical setting.
12 months
biochemically validated abstinence using saliva cotinine test
時間枠:6 months
6 months
biochemically validated abstinence using saliva cotinine test
時間枠:12 months
12 months

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。

スポンサー

捜査官

  • 主任研究者:William, Ho Cheung LI, PhD、The University of Hong Kong

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 (予想される)

2021年6月1日

一次修了 (予想される)

2022年12月1日

研究の完了 (予想される)

2023年12月1日

試験登録日

最初に提出

2016年4月26日

QC基準を満たした最初の提出物

2016年5月3日

最初の投稿 (見積もり)

2016年5月5日

学習記録の更新

投稿された最後の更新 (実際)

2020年11月4日

QC基準を満たした最後の更新が送信されました

2020年11月2日

最終確認日

2020年10月1日

詳しくは

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キーワード

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