Journal article
Maximizing patient recruitment and retention in a secondary stroke prevention clinical trial: Lessons learned from the STAND FIRM study
T Thayabaranathan, DA Cadilhac, VK Srikanth, SM Fitzgerald, RG Evans, J Kim, RP Gerraty, TG Phan, CF Bladin, MR Nelson, JH Frayne, AG Thrift
Journal of Stroke and Cerebrovascular Diseases | Published : 2016
Abstract
Background 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 ..
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Awarded by Helen Macpherson Smith Trust
Funding Acknowledgements
The Phase II study was partially supported by the Helen McPherson Smith Trust (6093) and the Ivor Ronald Evans Foundation, as administered by Equity Trustees. The Phase III STAND FIRM RCT was supported by a grant from the National Health and Medical Research Council (NHMRC 586605). A.G.T. was supported by a NHMRC Senior Research Fellowship (1042600). D.A.C. was supported by a cofunded NHMRC/National Heart Foundation Research Fellowship (1063761). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.