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Duration of Follow-Up Counselling on Smoking Cessation Outcomes

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ClinicalTrials.gov Identifier: NCT01893502
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Medicine, National University Hospital, Singapore

Tracking Information
First Submitted Date  ICMJE July 2, 2013
First Posted Date  ICMJE July 9, 2013
Last Update Posted Date April 7, 2017
Study Start Date  ICMJE June 2013
Actual Primary Completion Date March 18, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
Seven-day point prevalence abstinence [ Time Frame: Six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01893502 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
Average number of cigarettes smoked per day over the past seven days [ Time Frame: 3, 6, 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 8, 2013)
Exhaled carbon monoxide levels [ Time Frame: 3, 6, 12 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Duration of Follow-Up Counselling on Smoking Cessation Outcomes
Official Title  ICMJE Smoke Free Randomized Controlled Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE Behavioral: Telephone counselling from Quitline
Study Arms  ICMJE
  • Active Comparator: Group 1
    Participants will receive weekly proactive and live telephone counselling from Quitline (run by the Health Promotion Board) for one month
    Intervention: 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
    Intervention: Behavioral: Telephone counselling from Quitline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2017)
11
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2013)
124
Actual Study Completion Date  ICMJE March 18, 2016
Actual Primary Completion Date March 18, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893502
Other Study ID Numbers  ICMJE 2013/00057
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medicine, National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kay C See, MBBS National University Hospital, Singapore
PRS Account National University Hospital, Singapore
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP