Clinical trial NCT05973448: The Nightlight Falls Prevention Study
Official title: A Pragmatic Crossover Trial to Test the Effectiveness of a Novel Lighting System to Reduce Nighttime Falls in Persons With Alzheimer's Disease and Related Dementias
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Aging
Alzheimer Disease
Dementia Alzheimers
Dementia of Alzheimer Type
Fall Injury
Keywords: Aging
Alzheimer's Disease
Alzheimer's Disease Related Dementias
Assisted Living
Fall Injury
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-08-02
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participating community will have approximately 8-12 enrolled residents with ADRD. The AL communities will be randomized to four treatment sequences over the course of one year that define the order of the lighting intervention delivered across four 3-month (90 day) periods (N=390 residents). This design requires that the lights be turned on or off some periods, which will be done by research staff during scheduled visits. The four treatment sequences are chosen such that each resident receives control (C) lighting in two periods and novel lighting (L) in two periods and no more than 2 lighting changes. The four sequences are: CCLL, CLLC, LCCL, LLCC. There are no "washout" periods between the lighting conditions.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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."

Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of dementia
* Lives in a participating AL community
* Not blind
* Not on hospice and in a worsening state
* Not expected to die or transfer during the next 6 months
* Reside in a private room; or reside in a shared room if

  1. one resident is male and one is female and both are participating in the project, or
  2. they are of any gender, as long as there is a wall divider between their bedrooms

     Exclusion Criteria:
* None

Primary outcomes:
measure: Falls incidence density ratio
timeFrame: At study completion (one year)
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Sheryl Zimmerman, PhD
role: PRINCIPAL_INVESTIGATOR
References: