Comparison of Four Different Smoking Cessation Programmes

Study Overview
=================
Brief 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.

Detailed 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.

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.

Conditions
-----------------
Smoking, Smoking Cessation, Self-efficacy

Intervention / Treatment
-----------------
* Device: Standard 15-minute telephone counselling
* Device: Proactive telephone counselling
* Device: Interactive web-based smoking cessation programme
* Device: Self-help material


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone counselling<br> | Device: Standard 15-minute telephone counselling<br>* 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.<br>* Other names: Stoplinien.dk;Device: Proactive telephone counselling<br>* 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.<br>* Other names: Stoplinien.dk;|
| Experimental: Proactive telephone counselling<br> | Device: Proactive telephone counselling<br>* 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.<br>* Other names: Stoplinien.dk;|
| Experimental: web-based smoking cessation programme<br> | Device: Interactive web-based smoking cessation programme<br>* 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.<br>* Other names: ddsp.dk;|
| Active Comparator: Self-help material<br> | Device: Self-help material<br>* Participants receives self-help materials and on request information on other smoking cessation services if they wish.<br>* Other names: stoplinien.dk;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |