Ethics and dissemination
Important protocol modifications will be communicated to all relevant parties including investigators, trial participants, regulatory bodies, and the trial registry. The research team will protect participant confidentiality by: (i) removing direct identifiers from stored information [(i.e., names, social security numbers, medical record numbers)]; (ii) securing and limiting access to information that would identify participants; and (iii) limiting access to information stored to HSS and WCM investigators. Data will be stored on password protected network servers at HSS and WCM and the use of REDCap ensures the secure collection of data from participants. Peer coaches will not be collecting any data and will receive appropriate protected health information training.The final data set will be stripped of identifiers prior to release for sharing. Study data and associated documentation will be made available to researchers after approval from respective institutional review boards and under the following rules: a) the requestor shall provide resources for data transfer; b) the data is used for research purposes only; c) appropriate data security measures are taken by the requester. Trial results will be available to participants, healthcare professionals, and the public through press release and publications.