This paper is in the following e-collection/theme issue:
Effects of a Guided Web-Based Smoking Cessation Program With Telephone Counseling: A Cluster Randomized Controlled Trial
1Institute of General Practice, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
2Institute for Medical Biometry, Epidemiology und Medical Informatics (IMBEI), Universitätsklinikum des Saarlandes, Homburg/Saar, Homburg, Germany
Michael Mehring, MD
Institute of General Practice
Klinikum rechts der Isar
Technische Universität München
Phone: 49 614658914
Fax: 49 614658915
Background: Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners.
Objective: Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting.
Methods: The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks.
Results: We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95% CI -4.7 to 0.3; P=.080).
Conclusions: This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care. The limited statistical power and the high drop-out rate may have reduced the study’s ability to detect significant differences between the groups. Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome.
Trial Registration: German Register for Clinical Trials, registration number DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTMLTRIAL_ ID=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6Sff1YZpx).
(J Med Internet Res 2014;16(9):e218)
smoking cessation; Web-based; randomized controlled trial; primary care
Tobacco smoking is a major preventable cause of death worldwide. The use of tobacco is estimated to kill 5.4 million people a year. By 2030, tobacco will contribute to the deaths of more than 8 million people a year. The overwhelming majority of those deaths are predicted to occur in the developing world . Tobacco smokers are more prone to develop cancer and are also at substantially increased risk of developing heart disease, stroke, emphysema, and other severe diseases . Prevention and cessation are the two principal strategies against tobacco smoking. Surveys are already indicating that almost 70% of smokers would like to stop smoking completely [3,4]. There is evidence that cessation advice given by a doctor is an efficient way to support smokers to quit and that more intensive interventions in general practice increases the abstinence rate . Especially for younger smokers, the Internet may provide a vehicle to support this approach . There were 2.4 billion Internet users worldwide with an increasing trend in 2012 . The use of Web-based smoking cessation material provides low costs per user and results in high cost-effectiveness . Web-based programs are convenient for users because the content can be accessed easily anytime and anywhere. For some people, the greater level of anonymity online than in in-person counseling may be appealing.
The evidence of a variety of computer and other electronic aids were summarized in a meta-analysis by Chen et al . They concluded that computer and other electronic aids increase—to a small extent—the likelihood of prolonged smoking cessation compared with no intervention. A recently published Cochrane review  came to the conclusion that some Web-based interventions can assist smoking cessation, particularly those that are interactive and tailored to individuals. However, there were no consistent effects detected from trials that compared Internet interventions with usual care. Likewise, most of the included trials relied only on self-reported smoking status. Biochemical validation of self-reported cessation was only attempted in six of 28 trials.
Therefore, the aim of the present study was to compare the short-term effectiveness of a Web-based coaching program in combination with telephone counseling to usual care (see Multimedia Appendix 1). The Web-based program we tested, HausMed, combines an individually tailored strategy for smoking cessation with automated advice and feedback elements, in addition to monitoring via Internet and telephone counseling in general practice. Such a tool would facilitate the management of patients as they receive support from their general practitioner (GP) during the primary care process guided by the Web-based program. To date, very few findings within primary care patients and involving general practitioners are available. Additionally, the biochemical validation of the self-reported cessation status by a cotinine urine test was implemented in the present investigation to confirm the documented main outcome.
The study was designed as a two-armed, unblinded cluster-randomized controlled trial. At the beginning of the study, around 2000 Bavarian general practitioners (GPs) received a fax by the Bavarian Association of General Practitioners with information about the research project. All interested GPs were sequentially registered for randomization. After giving written consent, the participating practices were randomized either to the intervention or the control arm. The sequence of randomization (allocation 1:1) was provided by a methodologist, who did not participate in the execution of the study, via the program Research Randomizer . Randomization was concealed by using sequentially numbered, opaque, sealed envelopes held by the study coordinator. Before starting the recruitment of patients, physicians and practice nurses received detailed instructions by the research team on the study process (both intervention and control group) and on the coaching program (only intervention group).
Physicians assigned to the control arm were asked to change nothing in their usual way of counseling and to treat participants in the same manner as if they would have been non-participants. There was no structured documentation of the care provided. The patients recruited by intervention practices received free access to the Web-based coaching program. The patients of practices participating in the control arm were advised by the GPs in their individual way of usual care to quit smoking. The study was approved by the Medical Ethics Committee of the Technische Universität München (April 19, 2011) and was in accordance with ethical standards for human experimentation established by the Declaration of Helsinki. All participants gave written informed consent. A data and safety monitoring board was established before the beginning of the study.
Participants and Procedures
Participating physicians were general practitioners in Bavaria, Germany. The GPs were requested to recruit individuals with the desire for smoking cessation (see Multimedia Appendix 2). Individuals at least 18 years old and with Internet access were potentially eligible. Exclusion criteria were aged younger than 18 years, insufficient German language skills, and lack of Internet access. Further exclusion criteria were psychiatric disorders and posttraumatic stress disorder.
After the GP decided that patient should participate, an information form was given and discussed with the patients, and a participation form had to be signed. At the same time, the baseline data acquisition took place. All participants were asked to fill in a standardized questionnaire together with the GP. The standardized questionnaire comprised the following information: age, sex, height, weight, physical activity, years of tobacco use, number of cigarettes smoked per day, number of previous quit attempts, use of current nicotine replacement therapy (NRT), and reasons for smoking. Participants of the intervention group received a free Web-code. The physician filled in a form together with the patient with information about the potential existence and grade of a chronic obstructive pulmonary disease. This form with the Internet code was used by the patient for specification during the registration process of the Internet program. Participants of both groups were requested after 12 weeks to document the follow-up evaluation together with their physician. The follow-up comprised again information about smoking status, weight, physical activity, number of cigarettes smoked per day, and use of current NRT. At follow-up, a biochemical validation of the self-reported cessation status was also implemented through a cotinine urine test. Cotinine is detected in the urine for 2-4 days after the use of tobacco.
Physicians in the intervention group received €50 per participant for time and effort. Physicians in the control group received €25. Participants in the intervention group received free access to the smoking cessation program, which usually costs €79. Participants in the control group received €10 as an incentive to come into practice for follow-up investigation after 12 weeks. No methodical changes were made during the entire study period.
Anamnestic and health data were documented in a structured registration form including information about the potential existence and grade of a chronic obstructive pulmonary disease from the GP. The patient received a copy of this form in order to use the health data for subscribing via Internet into the HausMed coaching program  at home. A specific program was installed to allow the participants to log in without charge. After completion of a pre-assessment, the program generated individual coaching based on the given information of the physicians (registration form), the physical characteristics, and the everyday behavior of the participants.
The coaching program is based on the generally accepted principles of cognitive behavioral therapy and combined psychoeducation and motivational techniques with behavioral-therapeutic elements ; for example, education, realistic goal-setting, and individual resources, and in particular, the behavioral change theory targeted to smoking cessation by using inexpensive Internet and mobile technologies in combination with existing health care resources of GPs. The content of the coaching program aimed at achieving a lasting change of behavioral patterns with the help of individualized education, motivation, exercise guidance, daily SMS text messaging (short message service, SMS) reminders, self-monitoring via Internet and, finally, through active monitoring and approximately three telephone calls during the 12 weeks by the GPs or their staff. The framework of the program is based on the idea by Buchkremer and Batra, of the Department of Psychiatry and Psychotherapy, University of Tübingen, Germany [14,15]. The development and implementation of the Web-based smoking cessation program was carried out by WeCARE GmbH, Göttingen, Germany. The coaching program was subdivided into 12 different constitutive modules. Each module was performed for one week and contains particular tasks (Textbox 1), which were supported by corresponding daily SMS reminders. The participant had to perform a specific task each day and received a daily SMS regarding that specific task.
The reminder contained adapted information to maintain motivation, impart daily tips, and encourage daily performance of the respective task. The specific daily tasks were offered on the first day of each module. The coaching program also offered a variety of printed material (emergency plan, relaxation exercises, questionnaires, information, self-agreements, etc), which was connected to the respective task and included interactive buttons, video clips, and learning progress quizzes to examine learning success (Figures 1 and 2).