Ethics approval and consent to participate
WEST, SAID
Ethics approval was granted for the trial and its process evaluation on the 17th February 2017 by North West - Greater Manchester East Research Ethics Committee (REC REF: 16/NW/0890).The trial and its process evaluation were conducted in accordance with the Declaration of Helsinki and relevant data protection legislation. All participants gave their informed consent for inclusion before they participated in the trial and the process evaluation.Trial participants were, during the process of being informed and consented to be on the trial, asked if they were willing to be potentially contacted to participate in the interview study. A purposive sample of these participants (who said yes) were invited and again provided informed consent for this aspect of the trial. The facilitator, nurses and trial team members who are included in this process evaluation did so voluntarily. All gave informed consent. All of those who participated in this process evaluation had the right to withdraw at any time.