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dc.contributor.authorGerraty, Richard-
dc.contributor.otherThayabaranathan, T.-
dc.contributor.otherCadilhac, Dominique-
dc.contributor.otherSrikanth, V. K.-
dc.contributor.otherFitzgerald, Sharyn-
dc.contributor.otherEvans, R. G.-
dc.contributor.otherKim, J.-
dc.contributor.otherPhan, T. G.-
dc.contributor.otherBladin, C. F.-
dc.contributor.otherNelson, M. R.-
dc.contributor.otherFrayne, Judith-
dc.contributor.otherThrift, A. G.-
dc.identifier.citationJ Stroke Cerebrovasc Dis. 2016 Mar 18. pii: S1052-3057(16)00106-3en_US
dc.description.abstractBACKGROUND: Recruitment and retention of patients in a clinical trial is important for generalizability and robustness of findings. We aimed to investigate features of a study design that were associated with recruitment and retention in a Phase II and Phase III trial of a secondary prevention program for stroke. METHODS: Following informed consent in hospital, Phase II participants were randomized to intervention or usual care. Baseline clinical assessments were conducted at home approximately 3 months after discharge. In Phase III study, informed consent was obtained at home. We compared the characteristics of participants recruited and retained to 12 months for both phases. Interviews with study nurses were undertaken in order to ascertain their opinions of features of study design. Triangulation was used to identify the features of study design that nurses thought had improved recruitment and retention. RESULTS: All 24 eligible participants were recruited to the Phase II pilot study (100% recruitment), with 67% retention at 12 months. In Phase III study, 570 participants were recruited, and 93% of these participants had reached their 12-month assessment (nā€‰=ā€‰532) and were still participating. Consistent with the greater patient retention in Phase III study, nurses reported that patients' willingness to participate was greater when consent was obtained at home. CONCLUSION: Following a change in the consent process from hospital to home, more participants continued participation to 12 months. Pilot studies can provide important data to improve study design and better understand potential barriers to recruitment and retention.en_US
dc.subjectSecondary Preventionen_US
dc.subjectFeasibility Studiesen_US
dc.subjectPatient Recruitmenten_US
dc.subjectPatient Retentionen_US
dc.subjectPilot Projectsen_US
dc.subjectClinical Trials, Phase II as Topicen_US
dc.subjectClinical Trials, Phase III as Topicen_US
dc.subjectTrials, Randomized Clinicalen_US
dc.subjectClinical Trials, Randomizeden_US
dc.subjectDepartment of Medicine, Epworth Healthcare, Australia.en_US
dc.titleMaximizing patient recruitment and retention in a secondary stroke prevention clinical trial: lessons learned from the STAND FIRM study.en_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleJournal of Stroke and Cerebrovascular Diseasesen_US
dc.description.affiliatesStroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia.en_US
dc.description.affiliatesDepartment of Physiology, Monash University, Melbourne, Victoria, Australia.en_US
dc.description.affiliatesStroke Division, Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia.en_US
dc.description.affiliatesDepartment of Medicine (Austin Health), The University of Melbourne, Heidelberg, Victoria, Australia.en_US
dc.description.affiliatesMenzies Research Institute Tasmania, Hobart, Tasmania, Australia.en_US
dc.description.affiliatesDepartment of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.en_US
dc.description.affiliatesDepartment of Neurosciences, Box Hill Hospital, Monash University, Box Hill, Victoria, Australia.en_US
dc.description.affiliatesDepartment of Medicine, Box Hill Hospital, Monash University, Box Hill, Victoria, Australia.en_US
dc.description.affiliatesSchool of Medicine, University of Tasmania, Hobart, Tasmania, Australia.en_US
dc.description.affiliatesDepartment of Neurology, The Alfred Hospital, Prahran, Victoria, Australia.en_US
dc.type.studyortrialFeasibility Study-
Appears in Collections:Neurosciences

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