Grants and Contracts Details
Scope of Work: Mobility Toolkit Study (MBTK) University of Kentucky (UKY) • Obtain local IRB approval for the study protocol provided by the METRC Coordinating Center • Obtain Department of Defense Human Research Protections Office (DoD HRPO) approval • Participate in all required trainings on the study protocol and procedures • Obtain Coordinating Center certification • Maintain up-to-date master study documents including the protocol, standard operating procedures, informed consent, and case report forms (these are available by login on the METRC website) • Maintain up-to-date local study documents including standard operating procedures, delegation of authority logs, screening and enrollment logs, and event report documentation as required by the METRC Coordinating Center or by the local IRB • Screen patients ages 18 to 60 (inclusive) receiving surgical treatment for a tibial plateau, pilon, ankle or hindfoot fracture. This includes completion of the screening case report form (CRF00) and entry of the form into the REDCap database. • Discuss the Mobility Tool Kit Study with participants who screen as eligible during the index hospitalization. • Obtain and document Informed Consent, using appropriate/approved Informed Consent Forms from eligible patients who agree to participate in the study at the first post-op clinic visit. • Enroll a minimum of 7 patients in year 1. • For enrolled patients, collect and enter baseline data into the REDCap database. • Evaluate participants at study visits scheduled at time of first weight bearing, 3, 6 and 12 months following definitive treatment, and at interim clinic visits should they occur (e.g. follow-up for post-surgical complications). Evaluations include a mobility tool kit assessment, patient surveys and a review of the medical record to document readmissions and injury related complications. • Enter follow-up data into the REDCap database. • Respond to missing or incomplete data queries from the MCC • Obtain Continuing Review approval at the intervals specified by the local IRB and DoD HRPO • Obtain Master Protocol Amendment approval as necessary • Compensate patients $100 for completing study visits over the course of the 12 month follow-up period.
|Effective start/end date||9/30/18 → 9/29/19|
- Johns Hopkins University: $24,167.00
Explore the research topics touched on by this project. These labels are generated based on the underlying awards/grants. Together they form a unique fingerprint.