Comparison of Four Different Smoking Cessation Programmes (Fristart)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Danish Cancer Society
National Board of Health, Denmark
Information provided by (Responsible Party):
Peter Dalum, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01487642
First received: November 24, 2011
Last updated: December 19, 2011
Last verified: December 2011

November 24, 2011
December 19, 2011
August 2011
November 2012   (final data collection date for primary outcome measure)
Smoking cessation [ Time Frame: 14 months post baseline ] [ Designated as safety issue: No ]
We measure the 30 days point prevalence abstinence rate. We measure whether participants have been totally smokefree for at least 30 days prior to the follow-up date.
Same as current
Complete list of historical versions of study NCT01487642 on ClinicalTrials.gov Archive Site
  • Smoking cessation [ Time Frame: 3 month post baseline ] [ Designated as safety issue: No ]
    We measure the 30 days point prevalence abstinence rate. We measure whether participants have been totally smokefree for at least 30 days prior to the follow-up date.
  • smoking cessation [ Time Frame: 8 month post baseline ] [ Designated as safety issue: No ]
    We measure the 30 days point prevalence abstinence rate. We measure whether participants have been totally smokefree for at least 30 days prior to the follow-up date.
  • Change in self-efficacy [ Time Frame: At 3, 8 and 14 months ] [ Designated as safety issue: No ]
    Self-efficacy (SE) is measured on a 12 item scale. SE describes the individuals belief in own capacity to refrain from smoking in 12 specific situations. SE change is defined af the difference between baseline SE and SE at the 3,8 and 14 months follow-ups.
  • Motivational change [ Time Frame: At 3, 8 and 14 months ] [ Designated as safety issue: No ]
    Motivation was measured on a 10 point scale. ("How important is it for you to quit smoking"). Motivational change is defined af the difference between baseline motivation and motivation at the 3,8 and 14 months follow-ups.
  • Stage of change [ Time Frame: At 3, 8 and 14 months ] [ Designated as safety issue: No ]
    A measure of the participants intentions to quit smoking in the future ("Do you have plans to quit smoking? yes, within the next 30 days; yes, within the next six months; yes, but I no specific plans; No").
  • Smoking cessation expectations [ Time Frame: at 3,8,14 months ] [ Designated as safety issue: No ]
    We look at differences from baseline to follow-up with regard to participants perception of being smokefree on a six item scale: activities, physical fitness, health, appearance, happiness, stress.
Same as current
Not Provided
Not Provided
 
Comparison of Four Different Smoking Cessation Programmes
Study of the Effect of Two Different Types of Telephone Counselling Respectively and a Web-based Smoking Cessation Programme Among Adult Daily Cigarette Smokers.

The primary objective of the study is to compare the efficacy of four different smoking cessation programmes, including a proactive telephone counseling intervention, a reactive telephone counseling a and an interactive web-based intervention and (as control) written self-help material.

Smoking remains the most important threat to public health. The majority of smokers wish to quit smoking and every year a substantial part of smokers makes a quit attempt. However, the majority of smokers tries to quit unassisted and existing smoking cessation interventions are underused. In this study we test the effectiveness of four different smoking cessation interventions in a randomized controlled trial. The study provides knowledge on factors important for recruitment and gives indication on potential reach of interventions among the general population. This knowledge can help us in designing interventions that is both effective but also have a high reach in the general population.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Smoking
  • Smoking Cessation
  • Self-efficacy
  • Device: Standard 15-minute telephone counselling
    Subjects in arm 1 will benefit from a standard 15-minute telephone counselling session with a professional adviser which resembles a normal call to the national Quit-line. The telephone counselling will be reactive, thus the smoker initiates the call to a designated number to receive advice and information based on the needs and wishes of this particular smoker. Participants can receive self-help materials and information on other smoking cessation services if they wish.
    Other Name: Stoplinien.dk
  • Device: Proactive telephone counselling
    subjects in arm 2 will benefit from of five 15-minute calls from a professional adviser. Similar to the standard reactive telephone counselling, the proactive counselling will be a personal discussion and advice based on the needs and wishes of the particular participant. Together, the participant and adviser will determine a cessation date and schedule one call 3-7 days before the cessation date, one call immediately after the cessation date and three additional calls on days 3, 10 and 24, respectively, post-cessation.
    Other Name: Stoplinien.dk
  • Device: Interactive web-based smoking cessation programme
    Subjects in arm 3 will benefit from a tailored and interactive web-based smoking cessation programme. Besides interactive and personalised information generated on the webpage, the participant will receive by e-mail and SMS tailored feedback messages based on the particular profile of the participant on particular dates as well as topics during the cessation period depending on how well the cessation is proceeding.
    Other Name: ddsp.dk
  • Device: Self-help material
    Participants receives self-help materials and on request information on other smoking cessation services if they wish.
    Other Name: stoplinien.dk
  • Experimental: Telephone counselling
    Interventions:
    • Device: Standard 15-minute telephone counselling
    • Device: Proactive telephone counselling
  • Experimental: Proactive telephone counselling
    Intervention: Device: Proactive telephone counselling
  • Experimental: web-based smoking cessation programme
    Intervention: Device: Interactive web-based smoking cessation programme
  • Active Comparator: Self-help material
    Intervention: Device: Self-help material
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1600
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 16 and older
  • Current smoker: Willing to quit smoking within the next 12 weeks
  • Having a regular access to Internet
  • Having a personal e-mail address
  • Having a personal mobile cell phone with a Danish number
  • Given informed consent
  • Can read and understand Danish

Exclusion Criteria:

  • Less than 16 years of age
  • No personal e-mail address
  • No personal mobile cell phone
  • Not able to give informed consent
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01487642
NIPH-2066
Yes
Peter Dalum, University of Southern Denmark
University of Southern Denmark
  • Danish Cancer Society
  • National Board of Health, Denmark
Principal Investigator: Peter Dalum, Ph.d University of Southern Denmark
University of Southern Denmark
December 2011

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