A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction; Cognition Disorders
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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
Sampling method: Non-Probability Sample
Study population: 
        30 subjects with mild cognitive impairment due to AD, based on core clinical diagnostic
        criteria from the National Institute on Aging and Alzheimer's Association workgroup [Albert
        2011]