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Trial record 77 of 2033 for:    Smoking Cessation

Smoking Cessation Among People Attending A&E

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ClinicalTrials.gov Identifier: NCT02660957
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. LI William Ho Cheung, The University of Hong Kong

Brief Summary:
The purpose of this study is to test the effectiveness of using a brief, self-determination intervention on smoking cessation (immediate or progressive) for people attending AEDs.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: self-determination smoking cessation Other: placebo comparator Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1571 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of a Brief, Self-determination Intervention for Smoking Cessation (Immediate or Progressive) Among People Attending Emergency Departments: a Randomised Controlled Trial
Study Start Date : July 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: self-determination smoking cessation
Subjects in the intervention group will be allowed to select their own schedules of quitting after discussing their situation with the counsellor (quit immediately (QI), or quit progressively (QP) with the ultimate goal of completing cessation over an acceptable period). Subjects in the intervention group will receive a self-help quitting leaflet published by the Hong Kong Council on Smoking and Health plus a series of brief interventions using the AWARD model.
Behavioral: self-determination smoking cessation
a self-help quitting leaflet plus a series of brief interventions using the AWARD model

Placebo Comparator: health life
Subjects in the placebo control group will receive a smoking cessation leaflet published by the Hong Kong Council on Smoking and Health (COSH), as will the intervention group. Moreover, subjects in the placebo control group will undergo a similar schedule of telephone follow-up as those in the intervention group. They will receive a 'placebo' intervention with a 'placebo booster' of the same duration on increasing physical activity and fruit and vegetable intake.
Other: placebo comparator
suggest a healthy life style as a placebo comparator




Primary Outcome Measures :
  1. smoking quit rate change from baseline at 6-month follow-up between intervention and control group [ Time Frame: 6-month follow-up ]
    The primary outcome is biochemically validated abstinence at 6 months.


Secondary Outcome Measures :
  1. smoking quit rate change from baseline at 6-month and 12-month follow-up between intervention and control group [ Time Frame: 6-month and 12-month follow-up ]
    self-reported 7-day point prevalence (pp) quit rate at 6 months and 12 months between the intervention and control group

  2. smoking quit rate change from baseline at 12-month follow-up between intervention and control group [ Time Frame: 12-month follow-up ]
    biochemically validated abstinence at 12 months.

  3. smoking reduction rate change from baseline at 6-month and 12-month follow-up between intervention and control group [ Time Frame: 6-month and 12-month follow-up ]
    self-reported reduction of ≥ 50% in cigarette consumption at 6 and 12 months between the intervention and control group

  4. self-efficacy against tobacco change from baseline at 6-month and 12-month follow-up between intervention and control group [ Time Frame: 6-month and 12-month follow-up ]
    self-efficacy against tobacco at 6 and 12 months follow-up between intervention and control group

  5. quality of life change from baseline at 6-month and 12-month follow-up between intervention and control group [ Time Frame: 6-month and 12-month follow-up ]
    quality of life at 6 and 12 months follow-up between intervention and control group



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 18 years or above
  • triaged as semi-urgent (level 4) or non-urgent (level 5)
  • current smokers, either occasional or daily
  • express a willingness to quit smoking

Exclusion Criteria:

  • poor cognitive state or mental illness
  • participation in other smoking cessation programmes or services

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660957


Locations
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China
Department of Accident and Emergency, United Christian Hospital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Ho Cheung William Li, PhD The University of Hong Kong

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Responsible Party: Dr. LI William Ho Cheung, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02660957     History of Changes
Other Study ID Numbers: A&E
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

Keywords provided by Dr. LI William Ho Cheung, The University of Hong Kong:
Smoking cessation