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 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 (n = 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.
Key Words
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Article info
Publication history
Published online: March 19, 2016
Accepted:
February 13,
2016
Received in revised form:
February 11,
2016
Received:
June 30,
2015
Footnotes
Grant support: 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.
Identification
DOI: https://doi.org/10.1016/j.jstrokecerebrovasdis.2016.02.020
Copyright
© 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.
