NCT02660957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,571

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

1.7 years

First QC Date

January 18, 2016

Last Update Submit

May 19, 2019

Conditions

Smoking

Keywords

Smoking cessation

Outcome Measures

Primary Outcomes (1)

  • smoking quit rate change from baseline at 6-month follow-up between intervention and control group

    The primary outcome is biochemically validated abstinence at 6 months.

    6-month follow-up

Secondary Outcomes (5)

  • smoking quit rate change from baseline at 6-month and 12-month follow-up between intervention and control group

    6-month and 12-month follow-up

  • smoking quit rate change from baseline at 12-month follow-up between intervention and control group

    12-month follow-up

  • smoking reduction rate change from baseline at 6-month and 12-month follow-up between intervention and control group

    6-month and 12-month follow-up

  • self-efficacy against tobacco change from baseline at 6-month and 12-month follow-up between intervention and control group

    6-month and 12-month follow-up

  • quality of life change from baseline at 6-month and 12-month follow-up between intervention and control group

    6-month and 12-month follow-up

Study Arms (2)

self-determination smoking cessation

EXPERIMENTAL

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

health life

PLACEBO COMPARATOR

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

Interventions

self-determination smoking cessationBEHAVIORAL

a self-help quitting leaflet plus a series of brief interventions using the AWARD model

self-determination smoking cessation
placebo comparatorOTHER

suggest a healthy life style as a placebo comparator

health life

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Accident and Emergency, United Christian Hospital

Hong Kong, China

Location

Related Publications (2)

  • Li WHC, Xia W, Wang MP, Cheung DYT, Cheung KY, Wong CKH, Lam TH. Effect of quitting immediately vs progressively on smoking cessation for smokers at emergency department in Hong Kong: A posteriori analysis of a randomized controlled trial. PLoS One. 2023 Jan 26;18(1):e0280925. doi: 10.1371/journal.pone.0280925. eCollection 2023.

    PMID: 36701401DERIVED

  • Li WHC, Ho KY, Wang MP, Cheung DYT, Lam KKW, Xia W, Cheung KY, Wong CKH, Chan SSC, Lam TH. Effectiveness of a Brief Self-determination Theory-Based Smoking Cessation Intervention for Smokers at Emergency Departments in Hong Kong: A Randomized Clinical Trial. JAMA Intern Med. 2020 Feb 1;180(2):206-214. doi: 10.1001/jamainternmed.2019.5176.

    PMID: 31790546DERIVED

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Ho Cheung William Li, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 21, 2016

Study Start

July 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

CN(1)