scholarly journals Trial protocol and preliminary results for a cluster randomised trial of behavioural support versus brief advice for smoking cessation in adolescents

2010 ◽  
Vol 3 (1) ◽  
Author(s):  
Wolfgang A Markham ◽  
Christopher Bridle ◽  
Gillian Grimshaw ◽  
Alan Stanton ◽  
Paul Aveyard
Keyword(s):  
Smoking Cessation ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Trial Protocol ◽  
Preliminary Results ◽  
Behavioural Support ◽  
Cluster Randomised ◽  
Brief Advice

scholarly journals We Can Quit2 (WCQ2): a community-based intervention on smoking cessation for women living in disadvantaged areas of Ireland—study protocol for a pilot cluster randomised controlled trial

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Catherine Hayes ◽  
Aurelia Ciblis ◽  
Catherine Darker ◽  
Nadine Dougall ◽  
Joanne Vance ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Health Service ◽  
Sample Size ◽  
Quantitative Methods ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Pilot Trial ◽  
Cluster Randomised Trial ◽  
Community Based ◽  
Cluster Randomised

Abstract Background Tobacco use is the leading cause of preventable death in Ireland with almost 6000 smokers dying each year from smoking-related diseases. The ‘We Can Quit2’ (WCQ2) study is a pilot pragmatic two-arm, parallel-group, cluster randomised trial that aims to explore the feasibility and acceptability of trial processes including recruitment and to estimate parameters to inform sample size estimates needed for an effectiveness trial. This future trial will assess the effectiveness of a community-based smoking cessation intervention for women living in disadvantaged areas on short- and medium-term cessation rates. Methods/design Four matched pairs of districts (eight clusters) selected by area level of deprivation, geographical proximity, and eligibility for free medical services will be randomised to receive either WCQ (behavioural support + access to Nicotine Replacement Therapy (NRT)) delivered over 12 weeks by trained Community Facilitators (CFs) or to a form of usual care, a one-to-one smoking cessation service delivered by Smoking Cessation Officers from Ireland’s national health service, the Health Service Executive (HSE). Within each cluster, 24–25 women will be recruited (97 per arm; 194 in total) in 4 phases with consent obtained prior to cluster randomisation. The outcome measures will assess feasibility and acceptability of trial processes, including randomisation. Outcome data for a future definitive intervention (biochemically validated smoking abstinence) will be collected at end of programme (12 weeks) and at 6 months. WCQ2 has an embedded process evaluation using both qualitative and quantitative methods. This will be conducted (semi-structured client and CF interviews, intervention delivery checklist, and diary) to explore acceptability of trial processes, intervention fidelity, trial context, and implementation. Trial processes will be assessed against domains of the PRECIS-2 wheel to inform a future definitive trial design. Discussion Data from this pilot trial will inform the design and sample size for a full cluster randomised trial to determine the effectiveness of an intervention tailored to disadvantaged women in improving smoking cessation rates. It will provide transferable learning on the systems and implementation strategies needed to support effective design of future pragmatic community-based trials which address health promotion interventions for women in disadvantaged communities. Trial registration Concurrent to publication. Controlled trials ISRCTN74721694.

scholarly journals Quit in General Practice: a cluster randomised trial of enhanced in-practice support for smoking cessation

2010 ◽  
Vol 11 (1) ◽  
Author(s):  
Nicholas Zwar ◽  
Robyn Richmond ◽  
Elizabeth Halcomb ◽  
John Furler ◽  
Julie Smith ◽  
...  
Keyword(s):  
General Practice ◽  
Smoking Cessation ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

scholarly journals Effects of the Active Choices program on self-managed physical activity and social connectedness in Australian Defence Force veterans: Protocol for a cluster-randomised trial (Preprint)

2020 ◽  
Author(s):  
Nicholas D Gilson ◽  
Zoe E Papinczak ◽  
Gregore Iven Mielke ◽  
Catherine Haslam ◽  
Jonas Fooken ◽  
...  
Keyword(s):  
Physical Activity ◽  
Social Connectedness ◽  
Action Plan ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Service Utilisation ◽  
Behavioural Support ◽  
Research Activities ◽  
Cluster Randomised ◽  
Australian Defence Force

BACKGROUND A stepped-down program is one in which clients transition from the care of a health professional to self-managed care. Very little is known about the effectiveness of stepped-down physical activity (PA) programs for military service veterans. OBJECTIVE This study will test Active Choices, a stepped-down behavioural support program designed to help Australian Defence Force (ADF) veterans and their dependants who are clients of the Department of Veterans’ Affairs (DVA), transition from treatment by an exercise physiologist (EP) or physiotherapist to self-managed PA. METHODS The study is a cluster-randomised trial, with city-based EP or physiotherapy practices that recruit eligible DVA clients assigned to Active Choices or a comparison program. The study aims to recruit 104 participants (52 in each group). The Active Choices program will consist of two face-to-face (Weeks 1, 12) and two telephone (Weeks 4 and 8) consultations. During these sessions, the participant and Active Choices consultant will utilise an evidence-based resource booklet to review the key benefits of an active lifestyle, build an action plan for PA preferences, set and review goals, self-monitor progress relative to set goals, and discuss strategies to overcome PA barriers. Linking participants to local PA communities to overcome social isolation will be a program priority. The comparison program will consist of two consultations (Weeks 1 and 12) and use fewer behavioural support strategies (education, self-monitoring and action planning only) than Active Choices. Outcome measures will be administered at baseline, end-intervention (12 weeks), and follow-up (24 weeks) to assess changes in self-managed PA, psychological wellbeing and social connectedness. We will also measure health service utilisation and costs, and PA choices across the intervention period. End-intervention interviews will capture participant experiences. RESULTS Due to the impacts of the COVID-19 pandemic on human research activities in Australia, participant recruitment will commence when it is safe and feasible to do so. CONCLUSIONS Findings will provide valuable pilot data to support up-scaling of the program, and larger effectiveness trials with regional and rural, as well as city-based ADF veterans and their dependants. CLINICALTRIAL The trial is registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000559910; https://www.anzctr.org.au/ACTRN12620000559910.aspx

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