Duration of Follow-Up Counselling on Smoking Cessation Outcomes

April 6, 2017 updated by: Medicine, National University Hospital, Singapore

Smoke Free Randomized Controlled Trial

Smoking cessation improves mortality, even in patients with existing smoking-related morbidity. Telephone follow-up after smoking cessation counselling as been shown to be an important method to provide support to smokers and to improve quit rates, especially if three or more calls were used in addition to face-to-face counselling. While it is reasonable to assume that more counselling leads to better smoking cessation outcomes, little evidence exists over the amount of telephone follow-up counselling that is required for optimal and sustained abstinence. We aim to investigate if six-months of weekly telephone follow-up is superior to one-month of weekly telephone follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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

  • Singapore
      • Singapore, Singapore, 119228
        • National University 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current smokers among outpatients, including hospital employees, who provide informed consent for enrollment in the smoking cessation program

Exclusion Criteria:

  • Subjects who decline smoking cessation or who do not provide informed consent
  • Subjects who are participating or will be participating in other smoking cessation programs within the next six months
  • Subjects who are currently using smoking cessation medications
  • Subjects who cannot be followed up for at least six months, for instance, subjects who would be resigning and going overseas within the next six months
  • Subjects with language limitations that would impede completion of self-administered questionnaires
  • Subjects who are difficult to communicate with over the telephone (e.g. having speech or hearing problems)
  • Subjects with cognitive impairments that would impede counselling and follow-up
  • Subjects with no telephone number
  • Subjects who are too sick to receive smoking cessation counselling
  • Subjects with limited life expectancy (e.g. metastatic cancer)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Participants will receive weekly proactive and live telephone counselling from Quitline (run by the Health Promotion Board) for one month
Behavioral: Telephone counselling from Quitline
Active Comparator: Group 2
Participants will receive weekly proactive and live telephone counselling from Quitline (run by the Health Promotion Board) for six months
Behavioral: Telephone counselling from Quitline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seven-day point prevalence abstinence
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Average number of cigarettes smoked per day over the past seven days
Time Frame: 3, 6, 12 months
3, 6, 12 months

Other Outcome Measures

Outcome Measure
Time Frame
Exhaled carbon monoxide levels
Time Frame: 3, 6, 12 months
3, 6, 12 months

Collaborators and Investigators

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

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Kay C See, MBBS, National University Hospital, Singapore

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

June 1, 2013

Primary Completion (Actual)

March 18, 2016

Study Completion (Actual)

March 18, 2016

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

July 8, 2013

First Posted (Estimate)

July 9, 2013

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2013/00057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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