Effectiveness of a web-based self-help smoking cessation intervention: protocol of a randomised controlled trial

BACKGROUND: Cigarette smoking is a major risk factor for many chronic and fatal illnesses. Stopping smoking directly reduces those risks. The aim of this study is to investigate the effectiveness of a web-based interactive self-help programme for smoking cessation, known as the StopSite, by comparing it to an online self-help guide. Both interventions were based on cognitive-behavioural and self-control principles, but the former provided exercises, feedback and interactive features such as one-to-one chatrooms and a user forum, which facilitated mutual support and experience sharing. METHODS AND DESIGN: We conducted a randomised controlled trial to compare the interactive intervention with the self-help guide. The primary outcome measure was prolonged abstinence from smoking. Secondary outcomes were point-prevalence abstinence, number of cigarettes smoked, and incidence of quit attempts reported at follow-up assessments. Follow-up assessments took place three and six months after a one-month grace period for starting the intervention after baseline. Analyses were based on intention-to-treat principles using a conservative imputation method for missing data, whereby non-responders were classified as smokers. DISCUSSION: The trial should add to the body of knowledge on the effectiveness of web-based self-help smoking cessation interventions. Effective web-based programmes can potentially help large numbers of smokers to quit, thus having a major public health impact. TRIAL REGISTRATION: ISRCTN7442376

Activity and Life After Survival of a Cardiac Arrest (ALASCA) and the effectiveness of an early intervention service: design of a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Cardiac arrest survivors may experience hypoxic brain injury that results in cognitive impairments which frequently remain unrecognised. This may lead to limitations in daily activities and participation in society, a decreased quality of life for the patient, and a high strain for the caregiver. Publications about interventions directed at improving quality of life after survival of a cardiac arrest are scarce. Therefore, evidence about effective rehabilitation programmes for cardiac arrest survivors is urgently needed. This paper presents the design of the ALASCA (Activity and Life After Survival of a Cardiac Arrest) trial, a randomised, controlled clinical trial to evaluate the effects of a new early intervention service for survivors of a cardiac arrest and their caregivers.</p> <p>Methods/design</p> <p>The study population comprises all people who survive two weeks after a cardiac arrest and are admitted to one of the participating hospitals in the Southern part of the Netherlands. In a two-group randomised, controlled clinical trial, half of the participants will receive an early intervention service.</p> <p>The early intervention service consists of several consultations with a specialised nurse for the patient and their caregiver during the first three months after the cardiac arrest. The intervention is directed at screening for cognitive problems, provision of informational, emotional and practical support, and stimulating self-management. If necessary, referral to specialised care can take place. Persons in the control group will receive the care as usual.</p> <p>The primary outcome measures are the extent of participation in society and quality of life of the patient one year after a cardiac arrest. Secondary outcome measures are the level of cognitive, emotional and cardiovascular impairment and daily functioning of the patient, as well as the strain for and quality of life of the caregiver. Participants and their caregivers will be followed for twelve months after the cardiac arrest.</p> <p>A process evaluation will be performed to gain insight into factors that might have contributed to the effectiveness of the intervention and to gather information about the feasibility of the programme. Furthermore, an economic evaluation will be carried out to determine the cost-effectiveness and cost-utility of the intervention.</p> <p>Discussion</p> <p>The results of this study will provide evidence on the effectiveness of this early intervention service, as well as the cost-effectiveness and its feasibility.</p> <p>Trial registration</p> <p>Current Controlled Trials [ISRCTN74835019]</p