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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
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease and Related Dementias

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 28, 2023
    Last Updated
    April 21, 2023
    Sponsor
    Penn State University
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    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

    Learn more about this trial

    Smart Lighting for Nursing Home Residents With Dementia

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