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临床试验/NCT02454621
NCT02454621撤回1 期

Randomized Controlled Trial of the Smoking Cessation Volitional Help Sheet in Primary Care

University of Manchester2 个研究点 分布在 1 个国家开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
试验地点
2
主要终点
Nicotine dependence

研究概览

简要总结

The study will recruit patients who smoke from a general practice clinic and randomize them either to: (1) form implementation intentions by linking in memory situations in which they are tempted to smoke with strategies to avoid smoking in those situations using a volitional help sheet, or (2) to consider the situations in which they are tempted to smoke alongside possible strategies to avoid smoking as presented in the volitional help sheet but not to form implementation intentions. The effects on self-reported smoking will be assessed 1 month post-intervention.

详细描述

The study will recruit patients who smoke from a general practice clinic and randomize them either to: (1) form implementation intentions by linking in memory situations in which they are tempted to smoke with strategies to avoid smoking in those situations using a volitional help sheet, or (2) to consider the situations in which they are tempted to smoke alongside possible strategies to avoid smoking as presented in the volitional help sheet but not to form implementation intentions. The effects on self-reported smoking will be assessed 1 month post-intervention.

Design: This study will use questionnaires to assess participants smoking habits and then employ planning strategies to help then quit. Follow up questionnaires will be used to ascertain the success of planning on smoking cessation.

Sample Size: Upon entry to the General Practice (GP) clinic participants will be made aware of the study by the receptionist and asked to complete a copy if they are a smoker. The investigators are looking to recruit a minimum of fifty participants for each condition, but aim to collect data from as many participants as possible during the recruitment phase.

Recruitment: To participate in this study a person must be over the age of 18 and a smoker. The receptionists at the GP clinic will inform people of the study on entry and ask that they complete the questionnaire should they be 18 (or older) and smoke.

Procedure: Participants will be recruited from a GP clinic in Birmingham. They will be asked by the receptionists, upon entry to the clinic, to take one of the investigators' questionnaire packs if they are a smoker. These packs will be displayed on a table beside the reception desk. The packs begins with a briefing sheet that provides information about both how to complete the questionnaire and the reason for the study. The sheet will also inform participants that they do not have to complete the questionnaire that day, and they should feel free to come back and take part at a later date. It will also indicate to participants that they can withdraw from the study at any time, and a reason does not need to be provided. Once they have read the briefing sheet and generated their personal identity code, as instructed, they will complete the questionnaire. Completed questionnaires will be returned to the returns box. This will be securely stored in the GP clinic and collected once a week. Data from all packs will be collected and transferred to a secure university server before being shredded. A month after the participants have completed the initial questionnaire they will receive a follow-up questionnaire; either via e-mail or a hard copy via post where indicated. Data from the online questionnaire will be collected immediately, hard copy questionnaires will be returned via a pre-paid envelope (enclosed with the hard copy questionnaire) and transcribed onto a secure university computer before being shredded. Participants contact information will be kept separate from the data. Once participants have completed the follow-up questionnaire their involvement in the study is over.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • younger than 18 years

结局指标

主要结局

Nicotine dependence

时间窗: 1 month

Self-reported nicotine dependence

Quitting smoking

时间窗: 1 month

Self-reported smoking cessation

次要结局

  • Craving(1 month)
  • Self-identity(1 month)
  • Habit(1 month)
  • Action control(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Armitage

Professor of Health Psychology

University of Manchester

研究点 (2)

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