Smart Lighting for Nursing Home Residents With Dementia

Alzheimer's Disease and Related Dementias Clinical Trial

Official title:

The Effect of Smart Ambient Bright Light for Nursing Home Residents With Alzheimer's Disease and Related Dementias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825404
• Other study ID #: STUDY00020216
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: December 2023
• Source: Penn State University
• Contact: Ying-Ling Jao, PhD
• Phone: 814-865-5634
• Email: yuj15[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This proposed study seeks to develop a smart ambient bright light (SABL) intervention to provide auto-controlled, consistent indoor lighting that incorporates natural daylight. This SABL includes tunable LED lights, photosensors, and controllers. The SABL system has a pre-programmed 24-hour control schedule for illuminance settings to mimic the natural bright-dark cycle. It will automatically adjust the lights to accommodate the daylight effect to minimize staff burden and maximize the LI effect. The SABL will be installed in participants' bedrooms and designated areas in the dining rooms and activity rooms for four weeks. Each participant will wear a personal light monitor to measure the lighting dosage each participant receives. This study will address three aims: 1) pilot test the effect of SABL on reducing agitation in persons with ADRD, 2) evaluate the fidelity of the SABL delivery, and 3) evaluate the feasibility of implementing the SABL. The study will be conducted in two NHs in Pennsylvania. For aims 1 and 2, the investigators will use a crossover, cluster randomized control trial (RCT) and will enroll residents with ADRD and agitation. For aim 3, the investigators will use a mixed methods design and will interview NH stakeholders to evaluate the acceptability, feasibility, and appropriateness of the intervention. This is the first study that incorporates daylight in ambient light interventions and the first study that addresses the measurement, feasibility, and fidelity of lighting interventions. Findings will establish evidence-based implementation strategies and the best design for SABL to reduce agitation for persons with ADRD in NHs.

Description:

Up to 90% of people with Alzheimer's disease and related dementias (ADRD) experience at least one behavioral and psychological symptom of dementia (BPSD). Agitation is among the most common and challenging BPSD, especially in nursing home (NH) residents with ADRD. Thus, identifying an effective, non-pharmacological intervention to reduce agitation and other BPSDs is critical. Lighting is important for people with ADRD, especially those living in NHs, as they are not exposed to sufficient daylight. Lighting interventions (LIs) work to regulate suprachiasmatic nuclei, maintain a stable circadian rhythm and reduce agitation. LIs are not invasive and have minimal adverse effects, making them ideal interventions for persons with ADRD. Evidence has reported that LIs show improvement in agitation and other BPSDs for persons with ADRD. However, LIs have not been widely implemented in "real world" care settings. Traditional methods using light boxes that required persons with ADRD to sit and keep their eyes oriented toward a bright light led to compliance and workload issues. A more efficient approach to delivering LIs is necessary. Interest has arisen in designing NHs with the capability of providing LIs via ambient LIs. While a few studies have reported positive effects of ambient LIs on agitation, these studies were conducted in settings with window shades closed to minimize daylight. To establish ambient lighting as a feasible and effective intervention, a few fundamental gaps need to be addressed: 1) a feasible implementation approach to ambient LIs, and 2) intervention fidelity (ensuring the lighting received by participants meets the targets). This proposed study seeks to develop a smart ambient bright light (SABL) intervention to provide auto-controlled, consistent indoor lighting that incorporates natural daylight. This SABL includes tunable LED lights, photosensors, and controllers. The SABL system has a pre-programmed 24-hour control schedule for illuminance settings to mimic the natural bright-dark cycle. It will automatically adjust the lights to accommodate the daylight effect to minimize staff burden and maximize the LI effect. The SABL will be installed in participants' bedrooms and designated areas in the dining rooms and activity rooms for four weeks. Each participant will wear a personal light monitor to measure the lighting dosage each participant receives. This study will address three aims: 1) pilot test the effect of SABL on reducing agitation in persons with ADRD, 2) evaluate the fidelity of the SABL delivery, and 3) evaluate the feasibility of implementing the SABL. The study will be conducted in two NHs in Pennsylvania. For aims 1 and 2, the investigators will use a crossover, cluster randomized control trial (RCT) and will enroll residents with ADRD and agitation. For aim 3, the investigators will use a mixed methods design and will interview NH stakeholders to evaluate the acceptability, feasibility, and appropriateness of the intervention. This is the first study that incorporates daylight in ambient light interventions and the first study that addresses the measurement, feasibility, and fidelity of lighting interventions. Findings will establish evidence-based implementation strategies and the best design for SABL to reduce agitation for persons with ADRD in NHs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Age=55

• English speaking

• Nursing home residency=3 months

• Clinical Diagnosis of Alzheimer's Disease and related dementia

• Presence of agitation over the past week

Exclusion Criteria:

• Major sleep problems

• Major mental illness

• Severe vision impairment

• Severe acute or terminal illness

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease and Related Dementias
• Dementia

Intervention

Device:
• Smart Ambient Bright Light (SABL)
The Proposed Smart Ambient Bright Light (SABL) includes tunable LED lights, photosensors, and controllers. The SABL will provide bright light targeted at 400 lux and CS=0.3 in participant bedrooms and designated areas such as the dining room and activity room during the day and provide dim light =40 lux and CS=0.1 in participant bedrooms at night

Other:
• Control
Usual light.

Locations

Country	Name	City	State
United States	Valley View Retirement Community	Belleville	Pennsylvania
United States	Christ the King Manor	DuBois	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Figueiro MG, Hunter CM, Higgins P, Hornick T, Jones GE, Plitnick B, Brons J, Rea MS. Tailored Lighting Intervention for Persons with Dementia and Caregivers Living at Home. Sleep Health. 2015 Dec 1;1(4):322-330. doi: 10.1016/j.sleh.2015.09.003. — View Citation

Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. J Clin Sleep Med. 2019 Dec 15;15(12):1757-1767. doi: 10.5664/jcsm.8078. Epub 2019 Nov 8. — View Citation

Jao YL, Wang J, Liao YJ, Parajuli J, Berish D, Boltz M, Van Haitsma K, Wang N, McNally L, Calkins M. Effect of Ambient Bright Light on Behavioral and Psychological Symptoms in People With Dementia: A Systematic Review. Innov Aging. 2022 Mar 24;6(3):igac018. doi: 10.1093/geroni/igac018. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in light level: Lux at the facility level	Light level (lux) at the facility level will be measured manually on-site.	Twice a week for 13 weeks
Primary	Change in light level: CS at the facility level	Light level (CS) at the facility level will be measured manually on-site.	Twice a week for 13 weeks
Primary	Change in light level: Lux at the individual level	Light level (lux) at the individual level will be measured using a personal light monitor.	Weeks 1, 3, 5, 7, 9, 11, and 13
Primary	Change in light level: CS at the individual level	Light level (CS) at the individual level will be measured using a personal light monitor.	Weeks 1, 3, 5, 7, 9, 11, and 13
Primary	Change in agitation	Agitation will be measured using the Cohen Mansfield Agitation Inventory (CMAI) based on the primary care healthcare workers' (RN, LPN, or CNA) observations over the previous week. The total score ranges from 29 to 203; a higher score indicates a higher agitation level.	Weeks 1, 3, 5, 7, 9, 11, and 13
Primary	Intervention acceptability	The intervention acceptability of the lighting intervention will be measured based on nursing home stakeholders' perspectives using the Acceptability of Intervention Measure (AIM) and followed up by qualitative interviews. The total score ranges from 12-60; a higher score indicates a higher level of acceptability.	Week 13
Primary	Intervention feasibility	The intervention feasibility of the lighting intervention will be measured based on nursing home stakeholders' perspectives using the Feasibility of Intervention Measure (FIM) and followed up by qualitative interviews. The total score ranges from 9-45; a higher score indicates a higher level of feasibility.	Week 13
Primary	Intervention appropriateness	The intervention appropriateness of the lighting intervention will be measured based on nursing home stakeholders' perspectives using the Intervention Appropriateness Measure (IAM) and followed up by qualitative interviews. The total score ranges from 10-50; a higher score indicates a higher level of appropriateness.	Week 13
Secondary	Behavioral and Psychological Symptoms of Dementia (BPSD)	12 BPSDs will be measured, including delusions, hallucinations, dysphoria, euphoria, anxiety, agitation/aggression, apathy, irritability, disinhibition, aberrant motor behaviors, sleep, and appetite. BPSD will be measured using the Neuropsychiatry Inventory-Nursing Home version (NPI-NH). Each behavioral symptom is rated on a 0-3 scale; a higher score indicates a more severe of symptom.	Weeks 1, 3, 5, 7, 9, 11, and 13
Secondary	Affect	Six affective states will be measured: contentment, interest, pleasure, anxiety/fear, anger, and sadness, using the Philadelphia Geriatric Center Affect Rating Scale. Each item is rated on a 5-point scale (1-5); a higher score indicates a higher level of affect.	Weeks 1, 3, 5, 7, 9, 11, and 13
Secondary	Adverse effects.	Data on intervention-related adverse effects will be collected via inputs from certified nurse assistants (CNAs) using a checklist, which includes deteriorated BPSDs, skin rash, eye irritation, dizziness, nausea, or any other reactions. Each item will be checked as yes or no.	Weeks 1, 3, 5, 7, 9, 11, and 13