Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05973448 |
Other study ID # |
22-1162 |
Secondary ID |
1R01AG075010-01 |
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 28, 2023 |
Est. completion date |
August 31, 2026 |
Study information
Verified date |
April 2024 |
Source |
University of North Carolina, Chapel Hill |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This project will test the effectiveness of a novel intervention consisting of unobtrusive,
low-intensity, horizontal and vertical lights that outline the bathroom or entry way
doorframe in residents' rooms and provide visual cues to promote postural stability.
Specifically, this pragmatic crossover trial will enroll 390 assisted living residents with
dementia and follow them for one year, comparing the incidence of nighttime falls during the
lighting condition to the incidence of falls during the control condition; secondarily, it
will determine whether and to what extent the intervention effect is modified by resident-
and environmental-level risk factors, and satisfaction with the lighting system.
Description:
Falls are the primary cause of fatal and non-fatal injuries among persons 65 years of age and
older. Dementia is a major risk factors for falls, and assisted living (AL) communities are
the primary provider of residential care for ambulatory older adults with dementia, making AL
a critical setting in which to reduce falls. Forty-two percent of the more than 811,000 AL
residents across the U.S. have moderate or severe dementia, 84% are ambulatory, and more than
a third experience a fall in a six-month period, putting them among the 15% of AL residents
who suffer a hip fracture or other serious fall-related injury each year. Falls are
responsible for one-third of all hospitalizations of AL residents, and the resulting injuries
may lead to a cascade of events, including worsening function, nursing home transfer, and
death.
A significant number of these falls occur in the bedroom during the evening and night, when
AL staff are not present, thereby limiting their ability to intervene. However, the cause of
many of these falls -- impaired nighttime vision and related postural instability -- suggests
a promising avenue for intervention.
This project will test the effectiveness of a novel intervention consisting of unobtrusive,
low-intensity, horizontal and vertical lights that outline the bathroom or entry way
doorframe in residents' rooms and provide visual cues to promote postural stability. The
lighting system is particularly attractive and pragmatic because it is low cost, requires no
staff involvement, and can be easily installed in new buildings or retrofitted to existing
buildings.
The study investigators recently completed a NIH R21 exploratory/developmental randomized
crossover trial of this system and found a 34% decrease in falls due to a novel lighting
intervention. This NIH R01 project will build on that preliminary effort; if the results are
as promising as suggested, this pragmatic passive lighting system has the potential to reduce
falls and related sequelae for countless persons with Alzheimer's disease and related
dementias, and to become a new standard of care.
The intervention being tested is the effectiveness of a novel intervention consisting of
unobtrusive, low-intensity, horizontal and vertical lights that outline the bathroom or entry
way doorframe in assisted living (AL) residents' rooms in preventing night time falls. The
trial will enroll 390 AL residents with Alzheimer's disease and related dementias (ADRD) from
42 assisted living communities. The lighting will be installed in the rooms of all 390
enrolled AL residents and compared to standard nightlights (control condition). Using a
randomized crossover trial design, subjects will be examined under both conditions over one
year. The trial will enroll 14 communities per year for each of three years. Falls will be
measured using SafelyYou, a fall detection system that uses video cameras and artificial
intelligence to detect falls in resident rooms while maintaining resident privacy."