The Nightlight Falls Prevention Study

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05973448

Collaborator

National Institute on Aging (NIA) (NIH)

390

Enrollment

Location

Arms

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Alzheimer Disease Dementia Alzheimers Dementia of Alzheimer Type Fall Injury	Other: Novel Lighting Condition Other: Control Lighting Condition	N/A

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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

390 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

Single (Investigator)

Primary Purpose:

Health Services Research

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2026

Anticipated Study Completion Date :

Aug 31, 2026

Arms and Interventions

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"

Outcome Measures

Primary Outcome Measures

Falls incidence density ratio [At study completion (one year)]
(Number of falls/Number of Nights Novel) / (Number of falls/Number of Nights Control)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Has a diagnosis of dementia
Lives in a participating AL community
Attempts to get out of bed
Not wheelchair bound
Not blind
Not on hospice
Not expected to die or transfer during the year of the study
Does not share a bedroom (but may share a bathroom). Exception: roommates of different genders may participate because they can be differentiated on the video.