Comparison of Four Different Smoking Cessation Programmes

Smoking Cessation Clinical Trial

— Fristart  

Official title:

Study of the Effect of Two Different Types of Telephone Counselling Respectively and a Web-based Smoking Cessation Programme Among Adult Daily Cigarette Smokers.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01487642
• Other study ID #: NIPH-2066
• Status: Active, not recruiting
• Phase: N/A
• First received: November 24, 2011
• Last updated: December 19, 2011
• Start date: August 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2011
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1600
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Self-efficacy
• Smoking
• Smoking Cessation

Intervention

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.
• 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.
• 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.
• Self-help material
Participants receives self-help materials and on request information on other smoking cessation services if they wish.

Locations

Country	Name	City	State
Denmark	National institute of Public Health, University of Southern Denmark	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Danish Cancer Society, National Board of Health, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation	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.	14 months post baseline	No
Secondary	Smoking cessation	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.	3 month post baseline	No
Secondary	smoking cessation	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.	8 month post baseline	No
Secondary	Change in self-efficacy	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.	At 3, 8 and 14 months	No
Secondary	Motivational change	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.	At 3, 8 and 14 months	No
Secondary	Stage of change	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").	At 3, 8 and 14 months	No
Secondary	Smoking cessation expectations	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.	at 3,8,14 months	No