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Effectiveness of Negotiating Self-determination to Reduce Cigarette Consumption

2020년 11월 2일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

중재적

등록 (예상)

1566

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: William, Ho Cheung LI, PhD
  • 전화번호: 39176634
  • 이메일: william3@hku.hk

연구 연락처 백업

  • 이름: Ka Yan, HO Ho, MPhil
  • 전화번호: 39176328
  • 이메일: devilbb@hku.hk

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
위약 비교기: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
biochemically validated abstinence using exhaled CO test
기간: 6 months
6 months

2차 결과 측정

결과 측정
측정값 설명
기간
호기 CO 테스트를 사용하여 생화학적으로 검증된 금욕
기간: 12 개월
12 개월
자가 보고한 7일 금욕 포인트 유병률
기간: 6 개월
6 개월
자가 보고한 7일 금욕 포인트 유병률
기간: 12 개월
12 개월
담배 소비가 50% 이상 감소했다고 스스로 보고함
기간: 6 개월
6 개월
담배 소비가 50% 이상 감소했다고 스스로 보고함
기간: 12 개월
12 개월
self-efficacy against tobacco
기간: 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
기간: 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
기간: 6 months
6 months
biochemically validated abstinence using saliva cotinine test
기간: 12 months
12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: William, Ho Cheung LI, PhD, The University of Hong Kong

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2021년 6월 1일

기본 완료 (예상)

2022년 12월 1일

연구 완료 (예상)

2023년 12월 1일

연구 등록 날짜

최초 제출

2016년 4월 26일

QC 기준을 충족하는 최초 제출

2016년 5월 3일

처음 게시됨 (추정)

2016년 5월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 11월 2일

마지막으로 확인됨

2020년 10월 1일

추가 정보

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키워드

기타 연구 ID 번호

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개별 참가자 데이터(IPD) 계획

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아니

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

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