STRIDE Study at UTMB
Each year, 1 out of 3 adults aged 65 and over falls. A third of those falls result in moderate to severe injuries that can lead to further declines in health and loss of independence.
The National Institute on Aging (NIA) and the Patient-Centered Outcomes Research Institute (PCORI) have joined to support a clinical trial to test individually tailored interventions to prevent fall-related injuries as part of the Falls Injuries Prevention Partnership.
The study’s approach differs from others in that it will integrate proven falls reduction strategies into a cohesive intervention that can be adopted by many health care systems. The research team plans to enroll 6,000 adults age 75 and older with one or more modifiable risk factors for falls.
The primary trial outcome is the reduction in serious fall injuries, including nonspinal fractures, joint dislocation, head injuries, lacerations, internal injuries, and hypothermia. Secondary outcomes include reduction in all falls that cause injuries; all falls regardless of injury; indicators of wellbeing, physical function and disability, and anxiety and depression.
Assessment and Administration
Participants are assessed for their risk of falling, and receive either the current standard of care—primarily information about preventing falls—or the experimental study intervention in which individualized care plans are developed and administered.
The participant’s primary care physician reviews, modifies and approves the plans that include proven fall risk reduction interventions, which can be implemented by the research team, physicians and other health care 2 providers, caregivers and community-based organizations. The intervention centers on the concept of a falls care manager working with each participant’s primary care provider to develop the plans and monitor success.
Duration and Involvement
Many aspects of the intervention will be tested with small numbers of people during the first year of the study. Enrollment for the full trial will start in year two and take place over 18 months, if approved by NIA and PCORI. The participants will be followed for up to three years.
Patients and other stakeholders partner up with the investigators in national and local councils throughout the study development process and advise the research team on several important study features. They bring their unique personal perspective of how falls and fall injuries affect their lives, the difficulties they face in adhering to interventions, what outcomes are important to them, and what attributes of the interventions render them feasible, saleable, and sustainable.
Ten trial sites across the country were chosen to address geographic, rural/urban, academic/non-academic, and racial/ethnic diversity through a range of health care systems and models of care.
The 14 NIA-funded Claude D. Pepper Older Americans Independence Centers, which include the nation’s premier research programs in complex geriatric syndromes helped to develop the trial protocol and participates in the study. Some centers are involved as trial sites, while others focus on data analysis and dissemination of the study’s findings.