A Randomized Controlled Trial of a Nurse Delivered Stage-matched Smoking Cessation Intervention to Promote Heart Health of Cardiac Patients

June 14, 2011 updated by: Hospital Authority, Hong Kong

This study is a randomized controlled trial designed to evaluate the effectiveness of a nurse delivered stage-matched intervention to cardiac patients for cessation of tobacco use. Review of literature shows that there is a clear lack of empirical evidence on (1) using nurses to deliver stage-matched smoking cessation interventions, and (2) the effectiveness of such intervention for cardiac patients in Chinese populations. The ultimate goal of the intervention achieve a higher quit rate in the intervention group than in the controls. In addition, the change in the patient's smoking behaviour such as reduction of the number of cigarettes smoked, and progression to a higher stage of readiness to quit, will also be measured. This study is the first step to address the urgently needed data for (1) promoting the delivery of nurse-run stage-matched smoking cessation interventions to help patients stop smoking, (2) developing smoking cessation policy and programmes in the hospitals and for the health care system, and (3) contributing an evidence-based approach to orientate clinical services towards prevention, so as to reduce premature deaths and the enormous disease burden of our society.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: nurse-delivered stage-matched smoking cessation counseling

Study Type

Interventional

Enrollment (Anticipated)

1824

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Hong Kong, China
    - Queen Elizabeth Hospital
  - Hong Kong, China
    - Queen Mary Hospital
  - Hong Kong, China
    - Tuen Mun Hospital
  - Hong Kong, China
    - Pamela Youde Nethersole Eastern Hospital
  - Hong Kong, China
    - Caritas Medical Centre
  - Hong Kong, China
    - Princess Margaret Hospital
  - Hong Kong, China
    - United Christian Hospital
  - Hong Kong, China
    - Tseung Kwan O Hospital
  - Hong Kong, China
    - Ruttonjee Hospital / Tang Shiu Kin Hospital
  - Hong Kong, China
    - Tung Wah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient who is admitted to the participating centres and is a current smoker who has smoked daily in the past 7 days prior to hospitalization.
Patient speaks and reads Cantonese/Chinese

Exclusion Criteria:

Patient who is clinically too ill and not suitable to complete questionnaire and/or receive intervention.
Patient who does not speak or read Chinese

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quitting--to achieve higher quit rate in the cardiac patients (coronary artery disease) who are smokers Time Frame: continuous abstinence for one month at the time of 3, 6 and 12 month follow up	continuous abstinence for one month at the time of 3, 6 and 12 month follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction of the number of cigarettes smoked Time Frame: at the time of 3, 6 and 12 month follow up	at the time of 3, 6 and 12 month follow up
Progression to a higher stage of readiness to quit Time Frame: at the time of 3, 6 and 12 month follow up	at the time of 3, 6 and 12 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Collaborators

Research Grants Council, Hong Kong

Investigators

Principal Investigator: Sophia SC Chan, Dr, Department of Nursing Studies, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria