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Network to Promote Real-World Dementia Trials

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(Mabel Amber, Pixabay)

11 Sept. 2019. University and senior care center researchers are building a nationwide network to collect real-world evidence on caring for people with dementia. The project, led by a team from Brown University in Providence, Rhode Island and Hebrew SeniorLife in Boston, is funded by a five-year, $53.4 million grant from National Institute on Aging, part of National Institutes of Health.

A team from Brown University’s school of public health and Hebrew SeniorLife, a senior care center and research institute affiliated with Harvard Medical School, aim to establish ways for assisted-living and senior care facilities to readily test new techniques for caring for people with Alzheimer’s disease or related dementia. The researchers say innovations in care for people with Alzheimer’s disease is hampered by the lack of data from research on new methods of care conducted under real-world conditions.

The team, led by Brown University public health professor Vincent Mor and Hebrew SeniorLife’s Susan Mitchell, director of the center’s palliative care research, seeks to establish embedded pragmatic clinical trials in senior care facilities to collect high quality data. Pragmatic clinical trials take place at the point of care and are designed to collect evidence on treatment benefits and risks under real-world settings, as well as disseminate the results. NIH already established a Health Care Systems Research Collaboratory in 2012 to encourage embedded pragmatic clinical trials, which the Brown/Hebrew SeniorLife team is using as a model.

The researchers are setting up their Alzheimer’s disease and dementia research collaboratory, beginning with the basic infrastructure for the network and guidelines for conducting pragmatic clinical trials among people with Alzheimer’s disease or related dementia and their caregivers. The team then plans to enhance the network’s research and investigator capacity to conduct these trials, and disseminate findings and best practices for conducting the studies throughout the network.

The team aims to establish early on 40 pilot projects that assess non-drug, care-based interventions for people living with dementia. The researchers then expect to glean best practices on evaluating interventions for Alzheimer’s and dementia care from this experience to share with the research community at large. “The key is figuring out how to take an idea that worked in an ideal situation,” says Mor in a Brown University statement, “and adapt it so it can be piloted in the messy real-world system of care providers that exists across the U.S.”

The collaboratory expects to provide assistance to participating institutions on research design, statistics, collecting data on patient- and caregiver-reported outcomes, technical issues, and ethical concerns, such as gaining informed consent from people with dementia. The collaboratory also plans to address management issues such as project administration, partnering with other health care institutions, gaining participation from people with diverse backgrounds, and training junior staff.

The researchers expect their project to have a catalytic effect that benefits people with Alzheimer’s disease. Mitchell notes that the collaboratory “will transform the delivery, quality, and outcomes of care provided to Americans with dementia and their caregivers by accelerating the testing and adoption of evidence-based interventions within health care systems.” In this video, Mor and Mitchell tell more about the project.

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