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Authors
Gooday, Catherine https://orcid.org/0000-0001-5026-6788
Game, Frances
Woodburn, Jim
Poland, Fiona
Sims, Erika
Dhatariya, Ketan
Shepstone, Lee
Hardeman, Wendy
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Funding
Funding for this research was provided by:
Research Trainees Coordinating Centre (ICA-CDRF-2015-01-050)
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Article History
Received: 29 November 2019
Accepted: 27 April 2020
First Online: 16 June 2020
Ethics approval and consent to participate
: The trial has been reviewed by East Midlands-Derby Research Ethics Committee, April 10, 2017, ref 17/EM/0288. The trial is registered on the ISRCTN registry: reference number ISRCTN74101606. All participants will provide written consent to take part in the feasibility trial and will be re-consented by a member of the research team prior to participating in the qualitative interviews. In the future, if amendments to the protocol are required, the Chief Investigator (CG) will work with the sponsor to apply for approval from Research Ethics Committee and the Health Research Association. Following approval of the amendments this will be cascaded to the research sites. The NHS indemnity scheme will apply to the potential liability of the sponsor for harm to participants arising from the management and conduct of the research.
: Not applicable
: The investigators named on the protocol have no financial or other competing interests that impact on their responsibilities towards the scientific value or potential publishing activities associated with the trial.
