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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart ambient bright light | Experimental | The smart ambient bright light (SABL) intervention provides auto-controlled, consistent indoor lighting that incorporates natural daylight. |
|
| Control | Sham Comparator | Usual light. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Ambient Bright Light (SABL) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Lux During Intervention and Control Periods at the Facility Level | Average Lux during Intervention and Control Periods at the facility level This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. | Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. |
| Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Facility Level | Light CS level at the facility level was measured manually on-site. This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. | Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral and Psychological Symptoms of Dementia (BPSD) | BPSD were measured via the Neuropsychiatry Inventory, including delusions, hallucinations, dysphoria, euphoria, anxiety, agitation, apathy, irritability, disinhibition, aberrant motor behaviors, sleep, and appetite. Each symptom score ranges from 0-12, higher scores more severe. Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13 Intervention: the difference between weeks 1 (pre-intervention) and 5 (during intervention) for the intervention first group, and the difference between weeks 7 (pre-intervention) and 11 (during intervention) for the control first group. Control: the difference between weeks 7 (pre-control) and week 11 (during control) for the intervention first group, and the difference between weeks 1 (pre-control) and 5 (during control) for the control first group. |
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Resident participants
Inclusion Criteria:
Exclusion Criteria:
Staff participants:
Inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying-Ling Jao, PhD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley View Retirement Community | Belleville | Pennsylvania | 17004 | United States | ||
| Christ the King Manor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31855161 | Background | 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. | |
| 27066526 |
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This is a clustered cross-over RCT design; all participants will be in the intervention and control groups. The study period is 13 weeks, and the sequences were randomly assigned as follows:
Nursing Home A: Baseline (week 1), SABL (weeks 2-5), post-SABL/washout (weeks 6-7), control/usual light (weeks 8-11), and post control (weeks 12-13).
Nursing Home B: Baseline (week 1), control/usual light (weeks 2-5), post-control/washout (weeks 6-7), SABL (weeks 8-11), and post intervention (weeks 12-13).
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| ID | Title | Description |
|---|---|---|
| FG000 | Smart Ambient Bright Light, Then Usual Light | The residents received Smart Ambient Bright Light (weeks 2-5) followed by Usual Light (weeks 8-11) with two weeks of washout period in between (weeks 6-7). This is a cluster cross-over RCT design. Two participating nursing homes will be randomly assigned to two study sequences (one site will begin with the intervention period first followed by the control period while the other site will begin with the control period followed by the intervention period). All sites and all participants will be invited to the intervention and control group The smart ambient bright light (SABL) intervention provides auto-controlled, consistent indoor lighting incorporating natural daylight. 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. Control: usual light |
| FG001 | Usual Light, Then Smart Ambient Bright Light | The residents received usual light first (weeks 2-5) followed by Smart Ambient Bright Light (weeks 8-11) with two weeks of washout period in between (weeks 6-7). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Week 1) |
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| First Intervention (Weeks 2-5) |
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| Washout (Weeks 6-7) |
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| Second Intervention (Weeks 8-11) |
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| Follow up (Weeks 12-13) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Resident Participants | This is a cross-over RCT. All participants are invited to participate in the intervention and control. The smart ambient bright light (SABL) intervention provides auto-controlled, consistent indoor lighting that incorporates natural daylight. 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 Usual light This is a cross-over RCT. All participants will participate in the intervention and control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Lux During Intervention and Control Periods at the Facility Level | Average Lux during Intervention and Control Periods at the facility level This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. | Posted | Mean | Standard Deviation | Lux | Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. | Nursing Home Site | Nursing Home Site |
Weeks 1, 3, 5, 7, 9, 11, 13
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smart Ambient Bright Light | This is a cluster crossover RCT design. Two nursing homes will be randomly assigned into two different sequences; one site will begin with the intervention period, followed by the control period, while the other site will begin with the control period, followed by the intervention period. Intervention: Smart Ambient Bright Light (SABL) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Nervous system disorders | Systematic Assessment | Death due to health conditions deterioration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment | Medication-related nausea. Not related to the intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ying-Ling Jao | Penn State University | 8148655634 | yuj15@psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2023 | Dec 3, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2023 | Feb 5, 2025 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2023 | Dec 3, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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29 resident participants participated in randomized controlled trial for testing intervention efficacy.
22 staff participants participated in mixed methods interview for evaluating intervention feasibility.
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|
| Control | Other | Usual light. |
|
| Average Lux During Intervention and Control Periods at the Individual Level |
Light level (lux) at the individual level will be measured using a personal light monitor. This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. |
| Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. |
| Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Individual Level | This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. | Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. |
| Change in Agitation During the Intervention and Control Periods | Agitation was measured using Cohen-Mansfield Agitation Inventory (CMAI) in weeks 1, 3, 5, 7, 9, 11, 13. Total scores range from 29-203; higher scores, more agitation. For the intervention, data were the difference between week 1 (pre-intervention) and week 5 (during intervention) for the intervention first group, and data were the difference between weeks 7 (pre-intervention) and week 11 (during intervention) for the control first group. For the control, data were the difference between week 7 (pre-control) and week 11 (during control) for the intervention first group, and data were the difference between week 1 (pre-intervention) and week 5 (during intervention) for the control first group. | Intervention: Intervention first group: difference of weeks 1 & 5; Control first group: difference of weeks 7 & 11 Control: Intervention first group: difference of weeks 7 & 11; Control first group: difference of weeks 1 & 5 |
| Intervention Acceptability | The intervention acceptability of the lighting intervention were measured based on nursing home stakeholders' perspectives using the Acceptability of Intervention Measure (AIM) and followed up by qualitative interviews. The score ranges from 1-5; 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 1-5; a higher score indicates a higher level of feasibility. | Week 13 |
| Intervention Appropriateness | The 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 1-5; a higher score indicates a higher level of appropriateness. | Week 13 |
| Intervention: Intervention first group: difference of weeks 1 & 5; Control first group: difference of weeks 7 & 11 Control: Intervention first group: difference of weeks 7 & 11; Control first group: difference of weeks 1 & 5 |
| Affect | Six affects were measured: contentment, interest, pleasure, anxiety/fear, anger, and sadness, using the Philadelphia Geriatric Center Affect Rating Scale. Each affect score ranges from 1 to 5; higher scores, higher levels. Two nursing homes were randomly assigned to different sequences; one nursing home began with intervention (weeks 2-5), followed by control (weeks 8-11), while the other nursing home began with control (weeks 2-5), followed by intervention (weeks 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Intervention: the difference between weeks 1 (pre-intervention) and 5 (during intervention) for the intervention first group, and the difference between weeks 7 (pre-intervention) and 11 (during intervention) for the control first group. Control: the difference between weeks 7 (pre-control) and 11 (during control) for the intervention first group, and the difference between weeks 1 (pre-intervention) and 5 (during intervention) for the control first group. | Intervention: Intervention first group: difference of weeks 1 & 5; Control first group: difference of weeks 7 & 11 Control: Intervention first group: difference of weeks 7 & 11; Control first group: difference of weeks 1 & 5 |
| 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. Data were collected at weeks 1, 3, 5, 7, 9, 11, and 13. Data across all weeks was combined. | Weeks 1-13 combined |
| DuBois |
| Pennsylvania |
| 15801 |
| United States |
| 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. |
| 35602310 | Background | 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. |
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| BG001 | Stakeholder/Staff Participants | At the end of the intervention, we enrolled nursing home stakeholders, including certified nursing assistants, activity staff, nurses, directors of nursing, maintenance, and administrators. 22 participants (11 from each NH) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Intervention: Smart Ambient Bright Light | All residents received the Smart Ambient Bright Light (Intervention) either (weeks 2-5) or (weeks 8-11). |
| OG001 | Control: Usual Light | All residents received the Usual Light either during weeks 2-5 or weeks 8-11. |
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| Primary | Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Facility Level | Light CS level at the facility level was measured manually on-site. This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. | Posted | Mean | Standard Deviation | CS | Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. | Nursing home site | Nursing home site |
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| Primary | Average Lux During Intervention and Control Periods at the Individual Level | Light level (lux) at the individual level will be measured using a personal light monitor. This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. | Posted | Mean | Standard Deviation | Lux | Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. | Nursing Home Site | Nursing Home Site |
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| Primary | Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Individual Level | This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categorized as intervention and control periods. For the intervention period, the data reported were the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. For the control period, the data reported were the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. | Posted | Mean | Standard Deviation | CS | Intervention: the average of weeks 3 and 5 for the intervention first group and weeks 9 and 11 for the control first group. Control: the average of weeks 9 and 11 for the intervention first group and weeks 3 and 5 for the control first group. | Nursing Home Site | Nursing Home Site |
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| Primary | Change in Agitation During the Intervention and Control Periods | Agitation was measured using Cohen-Mansfield Agitation Inventory (CMAI) in weeks 1, 3, 5, 7, 9, 11, 13. Total scores range from 29-203; higher scores, more agitation. For the intervention, data were the difference between week 1 (pre-intervention) and week 5 (during intervention) for the intervention first group, and data were the difference between weeks 7 (pre-intervention) and week 11 (during intervention) for the control first group. For the control, data were the difference between week 7 (pre-control) and week 11 (during control) for the intervention first group, and data were the difference between week 1 (pre-intervention) and week 5 (during intervention) for the control first group. | Posted | Mean | Standard Deviation | Score on the scale | Intervention: Intervention first group: difference of weeks 1 & 5; Control first group: difference of weeks 7 & 11 Control: Intervention first group: difference of weeks 7 & 11; Control first group: difference of weeks 1 & 5 | Nursing Home Site | Nursing Home Site |
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| Primary | Intervention Acceptability | The intervention acceptability of the lighting intervention were measured based on nursing home stakeholders' perspectives using the Acceptability of Intervention Measure (AIM) and followed up by qualitative interviews. The score ranges from 1-5; a higher score indicates a higher level of acceptability. | Posted | Mean | Standard Deviation | score on a scale | Week 13 |
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| 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 1-5; a higher score indicates a higher level of feasibility. | Posted | Mean | Standard Deviation | score on a scale | Week 13 |
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| Primary | Intervention Appropriateness | The 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 1-5; a higher score indicates a higher level of appropriateness. | Posted | Mean | Standard Deviation | score on a scale | Week 13 |
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| Secondary | Behavioral and Psychological Symptoms of Dementia (BPSD) | BPSD were measured via the Neuropsychiatry Inventory, including delusions, hallucinations, dysphoria, euphoria, anxiety, agitation, apathy, irritability, disinhibition, aberrant motor behaviors, sleep, and appetite. Each symptom score ranges from 0-12, higher scores more severe. Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13 Intervention: the difference between weeks 1 (pre-intervention) and 5 (during intervention) for the intervention first group, and the difference between weeks 7 (pre-intervention) and 11 (during intervention) for the control first group. Control: the difference between weeks 7 (pre-control) and week 11 (during control) for the intervention first group, and the difference between weeks 1 (pre-control) and 5 (during control) for the control first group. | Posted | Mean | Standard Deviation | units on a scale | Intervention: Intervention first group: difference of weeks 1 & 5; Control first group: difference of weeks 7 & 11 Control: Intervention first group: difference of weeks 7 & 11; Control first group: difference of weeks 1 & 5 | Nursing Home Site | Nursing Home Site |
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| Secondary | Affect | Six affects were measured: contentment, interest, pleasure, anxiety/fear, anger, and sadness, using the Philadelphia Geriatric Center Affect Rating Scale. Each affect score ranges from 1 to 5; higher scores, higher levels. Two nursing homes were randomly assigned to different sequences; one nursing home began with intervention (weeks 2-5), followed by control (weeks 8-11), while the other nursing home began with control (weeks 2-5), followed by intervention (weeks 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Intervention: the difference between weeks 1 (pre-intervention) and 5 (during intervention) for the intervention first group, and the difference between weeks 7 (pre-intervention) and 11 (during intervention) for the control first group. Control: the difference between weeks 7 (pre-control) and 11 (during control) for the intervention first group, and the difference between weeks 1 (pre-intervention) and 5 (during intervention) for the control first group. | Posted | Mean | Standard Deviation | score on a scale | Intervention: Intervention first group: difference of weeks 1 & 5; Control first group: difference of weeks 7 & 11 Control: Intervention first group: difference of weeks 7 & 11; Control first group: difference of weeks 1 & 5 | Nursing Home Site | Nursing Home Site |
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| 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. Data were collected at weeks 1, 3, 5, 7, 9, 11, and 13. Data across all weeks was combined. | Posted | Number | participants | Weeks 1-13 combined | Nursing Home Site | Nursing Home Site |
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| 1 |
| 29 |
| 1 |
| 29 |
| 3 |
| 29 |
| EG001 | Usual Light | Control: Usual light | 1 | 29 | 1 | 29 | 0 | 29 |
|
|
| Pneumonia | General disorders | Systematic Assessment |
|
| Urinary tract infection | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Apathy |
|
| Appetite |
|
| Delusion |
|
| Depression |
|
| Disinhibition |
|
| Elation |
|
| Hallucinations |
|
| Irritability |
|
| Motor behaviors |
|
| Sleep |
|
| Pleasure |
|
| Anger |
|
| Fear |
|
| Sadness |
|