Smart Lighting for Nursing Home Residents With Dementia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Alzheimer's Disease and Related Dementias

Intervention / Treatment
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* Device: Smart Ambient Bright Light (SABL)
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart ambient bright light<br>The smart ambient bright light (SABL) intervention provides auto-controlled, consistent indoor lighting that incorporates natural daylight. | Device: Smart Ambient Bright Light (SABL)<br>* 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<br>|
| Sham Comparator: Control<br>Usual light. | Other: Control<br>* Usual light.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |