The Nightlight Falls Prevention Study

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alzheimer Disease; Aging; Fall Injury; Dementia Alzheimers; Dementia of Alzheimer Type
• Intervention / Treatment: Other: Novel Lighting Condition; Other: Control Lighting Condition

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."

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lighting Sequence 1: CCLL; In this arm, the participant will receive the control lighting condition (C) for the first two quarters (180 days) and then crossover to the novel lighting condition (L) for the last two quarters (180 days). Q1 - Control lighting Q2 - Control lighting Q3 - Novel lighting Q4 - Novel lighting	Other: Novel Lighting Condition; Horizontal and vertical lights over a doorway visible from the bed; Other Names: Indicated in sequence by "L"; Other: Control Lighting Condition; Standard night light plugged into wall socket; Other Names: Indicated in sequence by "C"
Other: Lighting Sequence 2: CLLC; In this arm, the participant will receive the control lighting condition (C) for the first quarter (90 days) and then crossover to the novel lighting condition (L) for the next two quarters (180 days) and finally crossover again to the control condition (C) for the last quarter (90 days). Q1 - Control lighting Q2 - Novel lighting Q3 - Novel lighting Q4 - Control lighting	Other: Novel Lighting Condition; Horizontal and vertical lights over a doorway visible from the bed; Other Names: Indicated in sequence by "L"; Other: Control Lighting Condition; Standard night light plugged into wall socket; Other Names: Indicated in sequence by "C"
Other: Lighting Sequence 3: LCCL; In this arm, the participant will receive the novel lighting condition (L) for the first quarter (90 days) and then crossover to the control lighting condition (C) for the next two quarters (180 days) and finally crossover again to the novel condition (L) for the last quarter (90 days). Q1 - Novel lighting Q2 - Control lighting Q3 - Control lighting Q4 - Novel lighting	Other: Novel Lighting Condition; Horizontal and vertical lights over a doorway visible from the bed; Other Names: Indicated in sequence by "L"; Other: Control Lighting Condition; Standard night light plugged into wall socket; Other Names: Indicated in sequence by "C"
Other: Lighting Sequence 4: LLCC; In this arm, the participant will receive the novel lighting condition (L) for the first two quarters (180 days) and then crossover to the control lighting condition (C) for the last two quarters (180 days). Q1 - Novel lighting Q2 - Novel lighting Q3 - Control lighting Q4 - Control lighting	Other: Novel Lighting Condition; Horizontal and vertical lights over a doorway visible from the bed; Other Names: Indicated in sequence by "L"; Other: Control Lighting Condition; Standard night light plugged into wall socket; Other Names: Indicated in sequence by "C"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls incidence density ratio	(Number of falls/Number of Nights Novel) / (Number of falls/Number of Nights Control)	At study completion (one year)

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Sheryl Zimmerman, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Aging; Assisted Living; Fall Injury; Alzheimer's Disease Related Dementias
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: 22-1162; 1R01AG075010-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: With the exception of the falls video clips, all other individual participant data collected during the trial will be shared after deidentification.
• IPD Sharing Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
• IPD Sharing Access Criteria: An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No