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SAP: The effect of sending advanced notification to trial participants two weeks before outcome data collection to improve retention: an embedded randomised controlled trial in the WORKWELL trial

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posted on 26.10.2021, 14:09 by Sarah RhodesSarah Rhodes, sarah cotterill, Alison HammondAlison Hammond, Denise Forshaw, Alexandra Haig, Christopher SuttonChristopher Sutton
This is the Statistical Analysis Plan for a Study Within a Trial (SWAT) embedded within the Workwell Trial. This SWAT was prepared and published in advance of 6 month data lock and release of SWAT data by the CTU.

Funding

The host trial is funded by Versus Arthritis grant number: 21761

The SWAT was funded by PROMETHEUS which is a major national programme of research funded by the Medical Research Council (MRC) to facilitate the routine embedding of a methodology research study within planned host trials.

History

Research ethics approval number

Ethical approval for this study was obtained from: the Health Research Authority West Midlands – Solihull Research Ethics Committee (18/WM/0327) (latest protocol dated 09.09.2019 v2).

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