Data collection and management
All staff involved in data collection are trained by the Principal Investigator (PI) and Study Coordinator and must demonstrate competence in completing the physical measurements described above. Questionnaire data are collected via REDCap, [Dr. Bean (PI) ensures that the trial is implemented according to the protocol, including adherence to eligibility criteria, safety protocols, and detailed manuals of operations. We closely monitor retention and report to the Data and Safety Monitoring Board (DSMB) at regular meetings. We have set alert points at drop-out rates of 25% (low alert; as this rate is nearing the estimated attrition rate; this will provide an early warning opportunity to address retention); 30% (moderate alert); 35% (high alert); and 40% (extreme alert). With early alerts to problems, action would be taken to avoid higher alert levels. If a higher alert level should arise, more drastic remedial action would be invoked.