The Nightlight Falls Prevention Study

Not Applicable

• Conditions: Aging; Dementia of Alzheimer Type; Alzheimer Disease; Dementia Alzheimers; Fall Injury
• Interventions: Other: Novel Lighting Condition; Other: Control Lighting Condition

• Registration Number: NCT05973448
• Lead Sponsor: University of North Carolina, Chapel Hill

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."

Study Timeline

• Study First Submitted: 2023-07-21
• Study Start: 2023-07-28
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 390

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lighting Sequence 2: CLLC	Control Lighting Condition	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
Lighting Sequence 3: LCCL	Novel Lighting Condition	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
Lighting Sequence 2: CLLC	Novel Lighting Condition	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
Lighting Sequence 1: CCLL	Novel Lighting Condition	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
Lighting Sequence 1: CCLL	Control Lighting Condition	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
Lighting Sequence 3: LCCL	Control Lighting Condition	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
Lighting Sequence 4: LLCC	Novel Lighting Condition	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
Lighting Sequence 4: LLCC	Control Lighting Condition	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

Primary Outcome Measures

Name	Time	Method
Falls incidence density ratio	At study completion (one year)	(Number of falls/Number of Nights Novel) / (Number of falls/Number of Nights Control)

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States