Overview

This trial is active, not recruiting.

Conditions smoking, smoking cessation, self-efficacy
Treatments standard 15-minute telephone counselling, proactive telephone counselling, interactive web-based smoking cessation programme, self-help material
Sponsor University of Southern Denmark
Collaborator Danish Cancer Society
Start date August 2011
End date November 2012
Trial size 1600 participants
Trial identifier NCT01487642, NIPH-2066

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
standard 15-minute telephone counselling Stoplinien.dk
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 Stoplinien.dk
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.
(Experimental)
proactive telephone counselling Stoplinien.dk
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.
(Experimental)
interactive web-based smoking cessation programme ddsp.dk
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.
(Active Comparator)
self-help material stoplinien.dk
Participants receives self-help materials and on request information on other smoking cessation services if they wish.

Primary Outcomes

Measure
Smoking cessation
time frame: 14 months post baseline

Secondary Outcomes

Measure
Smoking cessation
time frame: 3 month post baseline
smoking cessation
time frame: 8 month post baseline
Change in self-efficacy
time frame: At 3, 8 and 14 months
Motivational change
time frame: At 3, 8 and 14 months
Stage of change
time frame: At 3, 8 and 14 months
Smoking cessation expectations
time frame: at 3,8,14 months

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

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.
Principal investigator Peter Dalum, Ph.d
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by University of Southern Denmark.