Clinical Practice (assessment, diagnosis, treatment, knowledge translation/EBP, implementation science, program development)
Neurodegenerative Disease (e.g. MS, Parkinson's disease)
Technology (e.g. robotics, assistive technology, mHealth)
The STEP for MS portal design is a successful collaboration involving extension of a registry-oriented data platform to meet the needs of a multi-site clinical study.
Objective : To develop a comprehensive electronic data management portal for the STEP for MS trial for screening, enrollment, randomization, data collection, and participant tracking.
Design : STEP for MS is a comparative effectiveness trial comparing delivery of an exercise intervention via telerehabilitation vs. in a facility.
Setting : The study is conducted at 7 recruitment sites, as well as participant homes for the telerehabilitation arm. The centralized data management portal is based on the iConquerMS platform developed by Ordinal Data.
Participants (or Animals, Specimens, Cadavers) : Participants are people with MS with walking problems.
Interventions : The intervention is a standardized, individualized exercise program delivered either at home or at a center.
Main Outcome Measure(s) : The primary outcomes include walking ability and PROs related to walking, symptoms, self-efficacy, and behavior change.
The portal was designed by the study investigators and staff, technology developer, and data management partner through a process involving the development of use cases, definition of roles and data access, and iterative testing. An advisory board of people with MS, healthcare providers, and insurance and policymaker representatives provided feedback on participant facing components of the portal. The portal was customized to meet study specifications; features include integrated collection of PROs and clinical outcomes, separate portal dashboards for different roles, and automation of key study functions. Portal design began on January 2018; the study was launched in July 2018.
As of January 2019, the portal has supported screening of 121 candidates and enrollment of 61 participants; submission of 43 sets of follow-up assessments; and report generation for funder, DSMB, and other needs.
The STEP for MS portal design has been a successful collaboration involving extension of a registry-oriented data platform to meet the needs of a multi-site clinical study.