Brief Tobacco Cessation Intervention

NCT02494960 | Completed DMC

• 1 other identifier: MegaRCT
• Study Type: interventional
• Target: 13,671
• Locations: 1 country
• Sites: 1

Brief Summary

Traditional smoking cessation clinics and telephone quitlines are expensive and 'passive' as they require motivated smokers to visit the clinic or make a phone call to seek help. However, in most middle-resource countries, smoking cessation clinics are not well publicized. Most health care professionals (HCP) are not active in performing smoking cessation counselling to their patients. They are not aware of the available smoking cessation services or the benefits of such services and hence do not refer smokers to smoking cessation services. On the other hand, physicians play a critical role in reducing tobacco use by advising smoking patients to quit (Richmond, 1999). Physician's advice to quit smoking not only motivates smokers to quit but also increases their quitting confidence (Fiore et al., 2000; Ossip-Klein et al., 2000). Brief smoking cessation interventions have been shown to be effective with strong evidence from randomized controlled trials (RCTs), however, it is no evidence to show that longer interventions are more effective than shorter interventions. If carried out in routine clinical practice by all physicians and other HCP, brief interventions can potentially benefit a great number of smokers and increase smoking cessation rate. Therefore, we propose to examine the effect of a brief smoking cessation counselling intervention (10-20 seconds AWARD model) among patients using a randomized controlled trail (RCT) design in Guangdong province, China This project aims to evaluate the effect of physicians' brief smoking cessation intervention (AWARD model) in real busy clinic settings using a randomized controlled trial (RCT) design.

Conditions

Smoking

Keywords

smoking cessation intervention

Outcome Measures

Primary Outcomes (1)

• Smokers' self-reported 7-day point prevalence quitting rate

  Self-reported tobacco abstinence in the past 7 days

  up to 12-months follow-up

Secondary Outcomes (7)

• Biochemically validated quit rate

  6- and 12-months follow-up

• Non-biochemically validated quit rate

  6- and 12-months follow-up

• Self-reported sustained nicotine abstinence

  1- and 3-month follow-up

• Smoking reduction (cigarette or other tobacco product use decreased by at least 50%) among continuing smokers

  1-, 3-, 6- and 12-months

• Number of quit attempts

  1-, 3-, 6- and 12-months

Study Arms (3)

Control Group

PLACEBO COMPARATOR

The doctor will offer a placebo intervention.

Behavioral: Placebo intervention

Intervention Group A

EXPERIMENTAL

The doctor will offer the brief smoking cessation AWARD model . At 1-month follow-up survey, trained study personnel will repeat the brief smoking cessation AWARD model .

Behavioral: The brief smoking cessation AWARD model

Intervention Group B

EXPERIMENTAL

The doctor will offer the brief smoking cessation AWARD model.

Behavioral: The brief smoking cessation AWARD model

Interventions

The brief smoking cessation AWARD model BEHAVIORAL

* Ask whether or not the patient currently smokes * Warn the patients that at least one out of two smokers will be killed by smoking. Recent research shows that two out of three smokers will be killed by smoking. The 10-20-second script could be like 'I warn you that smoking can kill you by many serious diseases and that your chance to be killed prematurely by smoking is about 50% to 67%. * Advice the patients to quit now or as soon as possible because quitting can reduce the excess risks substantially. * Refer the patients to a smoking cessation clinic or call telephone quitlines (if available) as soon as possible, emphasizing that smoking cessation counsellors are caring and helpful. * Do it again: Repeat the intervention among smokers who fail to quit or relapse, and encourage them to try to quit again.

Intervention Group A; Intervention Group B

Placebo intervention BEHAVIORAL

Advice the smokers to eat vegetables, and engage in regular physical activities, and offer the smokers a card which contains information about the benefits of eating vegetables and a pictorial information leaflet which shows the recommended amount of vegetables and fruits an adult should eat a day

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients aged 18 years or above
• Smoke on at least 1 day in the past 30 days
• Chinese residents able to communicate in Chinese (Mandarin or Cantonese)
• Has a telephone

You may not qualify if:

• Smokers currently receiving smoking cessation interventions
• Smokers currently enrolled in other smoking cessation trials
• Smokers who need special care on quitting and are not suitable for AWARD intervention (determined by his/her doctor)
• Smokers with communication difficulties (physical or cognitive condition)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

5/F William MW Mong Block, LKS Faculty of Medicine Building, 21 Sassoon Road, Pokfulam

Hong Kong, Guangdong, China

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Tai hing Lam, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 10, 2015
• Study Start: August 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 14, 2018

Record last verified: 2018-12

Locations

CN (1)