Metric | Monitored and assessed | How this will be monitored and assessed | Thresholds/importance |
---|---|---|---|
Process: assesses participant recruitment and retention | a. Recruitment and refusal rates b. Retention and adherence rates | a. We will use USPS, phone and electronic mail, and the pre-enrollment form online to record all contact with potential participants’ acceptance or refusal reasons to join the intervention. We will record all participants’ flow through the recruitment, enrollment, intervention, and post-intervention sections of the study b. We will record adherence with the intervention via logbooks and video chats, and during follow-up assessments | a. Recruitment rate of ~ 70% and refusal rates of ~ 20%. This will provide information on optimal recruitment methods and reason for refusal b. Retention rate of ~ 80% and adherence rates of ~ 75% per participant. This will provide target areas for optimizing participant retention and intervention adherence |
Resource: assesses communication and monetary requirements of the study | c. Communication time with participants d. Communication needs of participants and staff e. Monetary costs of research | c. We will utilize a password protected database to monitor contact time with all potential and enrolled participants d. We will record all communication problems and alterations with participants and staff e. We will record all monetary costs for the study; for both the intervention and control groups | c. None; this will provide information on communication frequency, quality, and highlight communication problems d. None; this will establish communication needs and anticipated communication problems e. None; this will establish monetary costs to conduct the research and establish areas for cost saving |
Management: assesses data management including collection, analysis and storage | f. IRB protocol procedures and amendments g. Participant data collection, analysis, and storage | f. We will document and record time required for IRB protocol development and submission, and any follow-up amendments and modifications to the approved procedures g. We will document the time needed to record, clean, analyze, and store data in UIC Qualtrics, Redcap, Microsoft Excel, and SPSS Statistics | f. None; this will establish staff preparation time for IRB protocol development and amendments g. None; this will establish anticipated time needed for data management prior to analysis |
Scientific: assesses trial safety, handling of AEs, SAEs, and clinical emergencies, and participant burden | h. Reporting and handling AEs, SAEs and clinical emergencies i. Number of AEs, SAEs, and clinical emergences j. Participants’ experienced burden throughout the program | h. We will follow standard University IRB protocol to report all AEs, SAEs, and clinical emergencies, and ask participants to report and record all medical concerns via logbooks and video chats i. We will record the number of AEs, SAEs, and clinical emergencies experienced by and reported from participants in both intervention and control groups j. We will record participant feedback on the study during video chats, and in a post-intervention interview. We will also use participant self-reporting of total exercise time and rate of perceived exertion during each exercise session, reported via logbooks and video chats | h. None; this will detail what safety procedures should be implemented and establish any medical concerns participants would have i. None; this will determine the safety and feasibility of the intervention and highlight safety considerations j. None; this will determine acceptability and highlight considerations for alterations. This will also determine compliance and further allow correct conclusions to be drawn from the results |