Smart Lighting for Nursing Home Residents With Dementia
Primary Purpose
Alzheimer's Disease and Related Dementias
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smart Ambient Bright Light (SABL)
Control
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease and Related Dementias
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Smart ambient bright light
Control
Arm Description
The smart ambient bright light (SABL) intervention provides auto-controlled, consistent indoor lighting that incorporates natural daylight.
Usual light.
Outcomes
Primary Outcome Measures
Change in light level: Lux at the facility level
Light level (lux) at the facility level will be measured manually on-site.
Change in light level: CS at the facility level
Light level (CS) at the facility level will be measured manually on-site.
Change in light level: Lux at the individual level
Light level (lux) at the individual level will be measured using a personal light monitor.
Change in light level: CS at the individual level
Light level (CS) at the individual level will be measured using a personal light monitor.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05825404
Brief Title
Smart Lighting for Nursing Home Residents With Dementia
Official Title
The Effect of Smart Ambient Bright Light for Nursing Home Residents With Alzheimer's Disease and Related Dementias
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease and Related Dementias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Smart ambient bright light
Arm Type
Experimental
Arm Description
The smart ambient bright light (SABL) intervention provides auto-controlled, consistent indoor lighting that incorporates natural daylight.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Usual light.
Intervention Type
Device
Intervention Name(s)
Smart Ambient Bright Light (SABL)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Usual light.
Primary Outcome Measure Information:
Title
Change in light level: Lux at the facility level
Description
Light level (lux) at the facility level will be measured manually on-site.
Time Frame
Twice a week for 13 weeks
Title
Change in light level: CS at the facility level
Description
Light level (CS) at the facility level will be measured manually on-site.
Time Frame
Twice a week for 13 weeks
Title
Change in light level: Lux at the individual level
Description
Light level (lux) at the individual level will be measured using a personal light monitor.
Time Frame
Weeks 1, 3, 5, 7, 9, 11, and 13
Title
Change in light level: CS at the individual level
Description
Light level (CS) at the individual level will be measured using a personal light monitor.
Time Frame
Weeks 1, 3, 5, 7, 9, 11, and 13
Title
Change in agitation
Description
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.
Time Frame
Weeks 1, 3, 5, 7, 9, 11, and 13
Title
Intervention acceptability
Description
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.
Time Frame
Week 13
Title
Intervention feasibility
Description
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.
Time Frame
Week 13
Title
Intervention appropriateness
Description
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.
Time Frame
Week 13
Secondary Outcome Measure Information:
Title
Behavioral and Psychological Symptoms of Dementia (BPSD)
Description
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.
Time Frame
Weeks 1, 3, 5, 7, 9, 11, and 13
Title
Affect
Description
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.
Time Frame
Weeks 1, 3, 5, 7, 9, 11, and 13
Title
Adverse effects.
Description
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.
Time Frame
Weeks 1, 3, 5, 7, 9, 11, and 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying-Ling Jao, PhD
Phone
814-865-5634
Email
yuj15@psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julian Wang, PhD
Email
Jqw5965@psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Ling Jao, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31855161
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.
Results Reference
background
PubMed Identifier
27066526
Citation
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.
Results Reference
background
PubMed Identifier
35602310
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.
Results Reference
background
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Smart Lighting for Nursing Home Residents With Dementia
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