Mild Cognitive Impairment Clinical Trial
Official title:
REINVENT:A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits
REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials. The study aims to enroll 30 subjects from primary care practices coordinated through a single main study site. Potential subjects will be screened and randomized (1:1) at Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an in-person visit.
Mobile platforms have been leveraged in a variety of industries to drive dramatic efficiency
gains. The technology enables redesign of key processes allowing for the more efficient use
of labor and capital leading to better performance outcomes. Telehealth is the use of
electronic information and mobile telecommunications technologies to support long-distance
clinical health care, patient and professional health-related education, public health and
health administration. Much of the focus for the Institute of Medicine and other government
agencies has been the application of telehealth to improve access to healthcare and
specialized expertise by extending the reach of scarce resources to underserved populations.
These platforms are also routinely deployed as disease management tools. A natural extension
of these aims is the use of telehealth in the clinical development process, where both
improved efficiency and the ability to be more inclusive of a broader patient population are
critical steps in modernizing the clinical trial.
REINVENT is a non-interventional, multi-center, research network-based cross-over study
evaluating the potential utility of a telehealth platform in improving the efficiency of
clinical trials. The study aims to enroll 30 subjects from between 9 and 11 qualified
Radiant Clinical Research primary care physicians (PCP), coordinated through a single main
study site. Potential subjects will be screened and randomized (1:1) at Visit 1 into a
2-period crossover design study where 4 standard cognitive outcome measures are administered
at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an in-person visit. A
60-day interval is required between Visits 2 and 3 to reduce learning effects commonly
observed with repeated administration of cognitive assessments.
;
Observational Model: Case-Crossover, Time Perspective: Prospective
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