Each person in the trial will be assessed for his or her 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 will be developed and administered. The care plans will be presented to the participant’s primary care physician for review, modification, and approval and will include proven fall risk reduction interventions that can be implemented by the research team, physicians and other health care 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.
The research team plans to enroll 6,000 adults age 75 and older, living in the community, with one or more modifiable risk factors for falls. The first year of the study was a pilot phase, during which many aspects of the intervention were tested with small numbers of people across 10 clinical sites. The enrollment for the full trial started on August 1, 2015 and will take place over 18 months. The participants will be followed for up to three years.
The primary trial outcome is reduction in serious fall injuries, including non-spinal 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 well-being, physical function and disability, and anxiety and depression.
More Information on STRIDE can be found at: www.stride-study.org
The Yale Data Coordinating Center (DCC)
The Yale Data Coordinating Center (DCC) is a partnership between the Yale Center for Analytical Sciences, and the Yale Program on Aging (POA)/Older Americans Independence Center. It is composed of highly trained and experienced biostatistical and data management experts with the goal of conducting multi-center clinical research studies. The aim of the Yale DCC is to ensure that studies are efficiently and rigorously designed, conducted and analyzed through the use of state-of-the-art data collection and tracking systems, quality control procedures and statistical methods. Our faculty and staff have experience in all phases of clinical trials as well as observational studies (e.g. case-control, cohort).
The Yale DCC offers comprehensive coordination activities including:
- hypothesis development and definition of study objectives
- selection of study outcome measures
- determination of the statistical design (including randomization and sample size justification)
- development of case report forms
- design/implementation and maintenance of clinical data management systems
- data entry
- data quality control
- assurance of data security
- preparation of DSMB reports, and
- statistical analysis and reporting
Data management and analysis of the STRIDE Study will be coordinated by the Yale DCC.To find out if you live in an area where patients are being enrolled, please visit www.stride-study.org/clinical-trial-sites/