Alzheimer's Disease and Related Dementias
Conditions
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.
Interventions
DEVICESmart 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
OTHERControl
Usual light.
Sponsors
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
29 resident participants participated in randomized controlled trial for testing intervention efficacy. 22 staff participants participated in mixed methods interview for evaluating intervention feasibility.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Resident participants 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 Staff participants: Inclusion criteria: * Age≥18 * English speaking * Employed as a certified nurse assistant (CNA), activity staff, nurse, director of nursing (DON), director of maintenance, administer or other leadership position for at least 3 months. The CNA, activity staff, and nurse must have direct care interactions with the resident participant(s).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Appropriateness | Week 13 | 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. |
| Change in Agitation During the Intervention and Control Periods | 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 | 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 Acceptability | Week 13 | 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. |
| Intervention Feasibility | Week 13 | 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. |
| Average Lux During Intervention and Control Periods at the Facility Level | 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 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. |
| Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Facility Level | 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. | 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. |
| Average Lux During Intervention and Control Periods at the Individual Level | 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. | 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. |
| Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Individual Level | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Affect | 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 | 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. |
| Adverse Effects. | Weeks 1-13 combined | 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. |
| Behavioral and Psychological Symptoms of Dementia (BPSD) | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| 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) | 22 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (Weeks 2-5) | Death | 0 | 1 |
| Second Intervention (Weeks 8-11) | Death | 0 | 1 |
Baseline characteristics
| Characteristic | Stakeholder/Staff Participants | Total | Resident Participants |
|---|---|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 10.3 | 68.1 years STANDARD_DEVIATION 23.2 | 87.4 years STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 48 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 49 Participants | 27 Participants |
| Sex: Female, Male Female | 17 Participants | 37 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 29 | 1 / 29 |
| other Total, other adverse events | 3 / 29 | 0 / 29 |
| serious Total, serious adverse events | 1 / 29 | 1 / 29 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Smart Ambient Bright Light | Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Facility Level | 0.302 CS | Standard Deviation 0.07 |
| Control: Usual Light | Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Facility Level | 0.097 CS | Standard Deviation 0.02 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Smart Ambient Bright Light | Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Individual Level | 0.36 CS | Standard Deviation 0.09 |
| Control: Usual Light | Average Circadian Stimulation (CS) Level During Intervention and Control Periods at the Individual Level | 0.24 CS | Standard Deviation 0.08 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Smart Ambient Bright Light | Average Lux During Intervention and Control Periods at the Facility Level | 394.2 Lux | Standard Deviation 49.7 |
| Control: Usual Light | Average Lux During Intervention and Control Periods at the Facility Level | 97.4 Lux | Standard Deviation 23.82 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Smart Ambient Bright Light | Average Lux During Intervention and Control Periods at the Individual Level | 406.89 Lux | Standard Deviation 102.35 |
| Control: Usual Light | Average Lux During Intervention and Control Periods at the Individual Level | 286.69 Lux | Standard Deviation 83.5 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Smart Ambient Bright Light | Change in Agitation During the Intervention and Control Periods | -4.78 Score on the scale | Standard Deviation 13.55 |
| Control: Usual Light | Change in Agitation During the Intervention and Control Periods | -1.48 Score on the scale | Standard Deviation 13.05 |
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.
Time frame: Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Smart Ambient Bright Light | Intervention Acceptability | 4.10 score on a scale | Standard Deviation 0.93 |
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.
Time frame: Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Smart Ambient Bright Light | Intervention Appropriateness | 3.99 score on a scale | Standard Deviation 0.74 |
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.
Time frame: Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Smart Ambient Bright Light | Intervention Feasibility | 4.40 score on a scale | Standard Deviation 0.51 |
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.
Time frame: Weeks 1-13 combined
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Smart Ambient Bright Light | Adverse Effects. | 0 participants |
| Control: Usual Light | Adverse Effects. | 0 participants |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention: Smart Ambient Bright Light | Affect | Interest | 0.26 score on a scale | Standard Deviation 1.2 |
| Intervention: Smart Ambient Bright Light | Affect | Contentment | 0.22 score on a scale | Standard Deviation 1.09 |
| Intervention: Smart Ambient Bright Light | Affect | Pleasure | 0.15 score on a scale | Standard Deviation 1.2 |
| Intervention: Smart Ambient Bright Light | Affect | Anger | 0 score on a scale | Standard Deviation 0.88 |
| Intervention: Smart Ambient Bright Light | Affect | Fear | 0.04 score on a scale | Standard Deviation 1.22 |
| Intervention: Smart Ambient Bright Light | Affect | Sadness | -0.19 score on a scale | Standard Deviation 1.14 |
| Control: Usual Light | Affect | Fear | -0.15 score on a scale | Standard Deviation 1.32 |
| Control: Usual Light | Affect | Anger | 0.19 score on a scale | Standard Deviation 1.08 |
| Control: Usual Light | Affect | Contentment | 0.56 score on a scale | Standard Deviation 1.09 |
| Control: Usual Light | Affect | Interest | 0.48 score on a scale | Standard Deviation 1.09 |
| Control: Usual Light | Affect | Sadness | 0.00 score on a scale | Standard Deviation 1.07 |
| Control: Usual Light | Affect | Pleasure | 0.44 score on a scale | Standard Deviation 1.15 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Delusion | -1.70 units on a scale | Standard Deviation 4.72 |
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Elation | -0.52 units on a scale | Standard Deviation 2.71 |
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Anxiety | -1.15 units on a scale | Standard Deviation 3.42 |
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Hallucinations | -1.15 units on a scale | Standard Deviation 3.24 |
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Depression | -1.59 units on a scale | Standard Deviation 4.43 |
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Appetite | -1.70 units on a scale | Standard Deviation 3.54 |
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Irritability | -0.48 units on a scale | Standard Deviation 3.92 |
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Apathy | -1.04 units on a scale | Standard Deviation 3.41 |
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Motor behaviors | -0.78 units on a scale | Standard Deviation 3.15 |
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Disinhibition | -1.74 units on a scale | Standard Deviation 3.57 |
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Sleep | -2.04 units on a scale | Standard Deviation 3.37 |
| Intervention: Smart Ambient Bright Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Agitation | -1.11 units on a scale | Standard Deviation 3.88 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Sleep | 0.74 units on a scale | Standard Deviation 3.5 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Agitation | -0.07 units on a scale | Standard Deviation 3.44 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Anxiety | 0.30 units on a scale | Standard Deviation 3.77 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Apathy | 0.07 units on a scale | Standard Deviation 2.83 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Appetite | 0.63 units on a scale | Standard Deviation 1.98 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Delusion | 0.48 units on a scale | Standard Deviation 3.79 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Depression | 0.15 units on a scale | Standard Deviation 2.33 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Disinhibition | -0.52 units on a scale | Standard Deviation 2.62 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Elation | -0.52 units on a scale | Standard Deviation 1.53 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Hallucinations | 0.19 units on a scale | Standard Deviation 1.73 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Irritability | -0.30 units on a scale | Standard Deviation 3.07 |
| Control: Usual Light | Behavioral and Psychological Symptoms of Dementia (BPSD) | Motor behaviors | -1.11 units on a scale | Standard Deviation 4.36 |