The Nightlight Falls Prevention Study

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05973448
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Novel Lighting Condition — OTHER
    Horizontal and vertical lights over a doorway visible from the bed
  • Control Lighting Condition — OTHER
    Standard night light plugged into wall socket

Study Details

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 335 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.

Key Dates

Start date
Jul 28, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
335 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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: 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: 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: 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

Primary Outcome Measure

Falls incidence density ratio [ Time Frame: At study completion (one year) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-

Find similar trials in Chapel Hill, NC

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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