Stathi, Afroditi
Withall, Janet http://orcid.org/0000-0003-0196-5309
Crone, Diane
Hawley-Hague, Helen
Playle, Rebecca
Frew, Emma
Fenton, Sally
Hillsdon, Melvyn
Pugh, Christopher
Todd, Chris
Jolly, Kate
Cavill, Nick
Western, Max
Roche, Sarah
Kirby, Nigel
Boulton, Elisabeth
Thompson, Janice
Chatwin, Katie
Davies, Amy
Szekeres, Zsofia
Greaves, Colin
Funding for this research was provided by:
Public Health Research Programme (130156)
Article History
Received: 15 August 2023
Accepted: 27 October 2023
First Online: 29 November 2023
Declarations
:
: The study protocol has been conducted according to the Declaration of Helsinki and has been approved by the National Health Service (NHS) London—Surrey Research Ethics Committee (REC) (21/LO/0433). The study is registered as a current randomised controlled trial (ISRCTN 17660493).Any amendments to the protocol will be submitted for REC approval as appropriate. Substantial amendments that require review by REC will not be implemented until the REC grants a favourable opinion for the study.Verbal consent will be requested before the phone screening interview begins. No phone screening will be conducted without participant consent. Allocation of a study ID number will be taken as evidence that consent was obtained. Written consent will be taken before face-to-face screenings begin (Additional file InternalRef removed). The study will be fully explained by a researcher who has completed Good Clinical Practice (GCP) training. The potential participant will be offered an opportunity to ask questions. Those who agree to participate will be asked to complete, sign and date the study consent form. The researcher obtaining consent will also sign and date the consent form. A copy of the signed form will be given, or sent, to the participant. The original signed form will be stored in the local Site File.
: The authors declare that they have no competing interests.