PMCAN for Smokers at Smoking Hotspots

NCT ID: NCT02935231

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2016-11-30

Brief Summary

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Background: Many smokers cannot quit due to nicotine withdrawal symptoms, which peak at the first week of abstinence. Proactive recruitment of smokers is needed as most smokers do not seek smoking cessation (SC) services. A smoking hotspot (SH) is defined as a public outdoor place where smokers stop/linger and smoke. We aim to include a reasonably "representative" or unbiased sample of SH at different locations from all 3 regions of Hong Kong. We will randomly select 6 eligible SH (2 in each regions) from the 15 hotspots in our previous community trial.

Methods: Two trained SC ambassadors (student helpers) and one supervisor (experienced research assistant) will be deployed for each session of intervention at a SH. Potential subjects will be approached using the "a-foot-into-the-door" method in which SC ambassador will ask if smoker would like to reduce/quit smoking and receive SC intervention or advices. Smokers will be assessed for eligibility and informed written consent will be sought. Subjects will complete a brief self-administered questionnaire (baseline) using tablet. To reduce later hang-ups of telephone interventions or surveys, SC ambassador will save contact number of the trial into subjects' mobile phones.

Discussion: The findings will provide much needed and original evidence to support a main RCT on these new, proactive, simple and low-cost interventions for improving current SC services and policy for smokers who do not actively seek help from SC services in Hong Kong and elsewhere.

Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nicotine Replacement Therapy

This experimental group receives health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.

Group Type EXPERIMENTAL

Nicotine Replacement Therapy (NRT)

Intervention Type DRUG

1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.

Health warning leaflet

Intervention Type OTHER

An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.

Minimal Cessation Advice & Nicotine Replacement Therapy

This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.

Group Type EXPERIMENTAL

Nicotine Replacement Therapy (NRT)

Intervention Type DRUG

1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.

Minimal Cessation Advice (MCA)

Intervention Type BEHAVIORAL

Brief smoking cessation advice using AWARD model. AWARD: (1) Ask smoking habit; (2) Warn about smoking risk; (3) Advice to quit as soon as possible; (4) Refer to smoking cessation service; and (5) Do-it-again: if relapse/fail.

Health warning leaflet

Intervention Type OTHER

An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.

Minimal Cessation Advice

This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet.

Group Type EXPERIMENTAL

Minimal Cessation Advice (MCA)

Intervention Type BEHAVIORAL

Brief smoking cessation advice using AWARD model. AWARD: (1) Ask smoking habit; (2) Warn about smoking risk; (3) Advice to quit as soon as possible; (4) Refer to smoking cessation service; and (5) Do-it-again: if relapse/fail.

Health warning leaflet

Intervention Type OTHER

An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.

Control

This control group receives a health warning leaflet.

Group Type ACTIVE_COMPARATOR

Health warning leaflet

Intervention Type OTHER

An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.

Interventions

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Nicotine Replacement Therapy (NRT)

1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.

Intervention Type DRUG

Minimal Cessation Advice (MCA)

Brief smoking cessation advice using AWARD model. AWARD: (1) Ask smoking habit; (2) Warn about smoking risk; (3) Advice to quit as soon as possible; (4) Refer to smoking cessation service; and (5) Do-it-again: if relapse/fail.

Intervention Type BEHAVIORAL

Health warning leaflet

An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.

Intervention Type OTHER

Other Intervention Names

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NRT MCA

Eligibility Criteria

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Inclusion Criteria

* Adult smokers aged 18+ who smoke cigarettes daily.
* Exhaled carbon monoxide (CO) level of 4ppm or above.
* Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua)

Exclusion Criteria

* Smokers who have contraindication for NRT use: severe angina, arrhythmia, myocardia infraction, pregnancy (or intended to become pregnant \<6 months) or breastfeeding.
* Smokers who have psychiatric/psychological diseases or regular psychotropic medications
* Smokers who are using SC medication, NRT, other SC services or projects.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Wang Man-Ping

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Man Ping WANG

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Other Identifiers

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PMCANp_2016

Identifier Type: -

Identifier Source: org_study_id

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