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This study is designed to test the hypothesis that an intervention increasing exposure to daylight indoors will reduce depression and other neuropsychiatric symptoms among people living with dementia in long term care facilities.
Exposure to sufficient daylight indoors is a novel and potentially effective nonpharmacological treatment option for reducing depression and other neuropsychiatric symptoms for people living with dementia in long term care facilities. However, there are currently no minimum requirements for daylight access in care facilities. In urban settings, it is common for residents to spend the majority of the day indoors, illuminated by electrical light sources that deliver light with significantly lower intensities and reduced spectrum compared with daylight.
A 12-week pilot study was conducted in 8 dementia care facilities involving (n = 83) participants addressing the hypothesis that an intervention increasing indoor exposure to daylight will reduce depression and other neuropsychiatric symptoms. At 4 facilities, staff was enlisted to increase daylight exposure by taking participants to a perimeter room with daylight exposure for socialization in the morning (8:00 - 10:00 AM) each day. At the other 4 facilities, a control group were taken to a similar sized area without daylight for socialization under typical electrical lighting conditions. Outcome measures for depression and other neuropsychiatric symptoms were taken at the beginning and end of the 12-week study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | At the 4 facilities in the control arm, participants received the usual care. During the period from 8:00 - 10:00 AM each day, the control group was taken to a similar sized area indoors (without daylight) for socialization under typical electrical lighting conditions. | |
| Daylight Intervention | Active Comparator | At the 4 facilities in the active light intervention arm, staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daylight Intervention | Other | Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cornell Scale for Depression in Dementia (CSDD) | The Cornell Scale for Depression in Dementia (CSDD) was used to measure depression. The CSDD is designed for the assessment of depression in older people with dementia who can at least communicate basic needs. The CSDD scale ranges from 0 to 38, with higher scores indicating higher levels of depression. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 are associated with absence of significant depressive symptoms. | A CSDD score was taken at the beginning of the 12-week study and once again at the end of the 12-week study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) | The Neuropsychiatric Inventory Nursing Home Version (NPI-NH) was used to measure neuropsychiatric symptomatology. The NPI-NH is a scale designed for assessment of people with dementia residing in extended care facilities. The NPI-NH includes ten behavioral areas (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior) and two types of neurovegetative changes (sleep and nighttime behavior disorders, appetite and eating disorders). Each of the 12 areas is scored on a subscale ranging from 0-12, where higher scores indicate greater neuropsychiatric symptomatology. A summary score is obtained from summing all 12 subscale scores. The summary score ranges from 0 - 144, where higher scores indicate greater neuropsychiatric symptomatology. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Konis, Ph.D | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alhambra Dementia Care | Alhambra | California | 91801 | United States | ||
| Sierra Vista Memory Care Community |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | At the 4 facilities in the control arm, participants received the usual care. During the period from 8:00 - 10:00 AM each day, the control group was taken to a similar sized area indoors (without daylight) for socialization under typical electrical lighting conditions. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2016 |
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| A NPI-NH score was taken at the beginning of the 12-week study and once again at the end of the 12-week study. |
| Azusa |
| California |
| 91702 |
| United States |
| Calabasas Memory Care Community | Calabasas | California | 91302 | United States |
| Costa Mesa Dementia Care | Costa Mesa | California | 92627 | United States |
| Los Angeles Dementia Care (Beverly Place) | Los Angeles | California | 90048 | United States |
| Redondo Beach Dementia Care (Beach Cities) | Redondo Beach | California | 90277 | United States |
| San Juan Capistrano Memory Care Community | San Juan Capistrano | California | 92675 | United States |
| Tustin Hacienda Memory Care Community | Tustin | California | 92780 | United States |
| Daylight Intervention |
At the 4 facilities in the active light intervention arm, staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study. Daylight Intervention: Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | At the 4 facilities in the control arm, participants received the usual care. During the period from 8:00 - 10:00 AM each day, the control group was taken to a similar sized area indoors (without daylight) for socialization under typical electrical lighting conditions. |
| BG001 | Daylight Intervention | At the 4 facilities in the active light intervention arm, staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study. Daylight Intervention: Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cornell Scale for Depression in Dementia (CSDD) | The Cornell Scale for Depression in Dementia (CSDD) was used to measure depression. The CSDD is designed for the assessment of depression in older people with dementia who can at least communicate basic needs. The CSDD scale ranges from 0 to 38, with higher scores indicating higher levels of depression. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 are associated with absence of significant depressive symptoms. | Included patients with CSDD obtained within 4 months of start of study, leading to 28 analyzed for the control group (of 31) and 38 analyzed for the Daylight Intervention group (of 46). Baseline means and SDs reported here do not account for clustering within facility. | Mean | Standard Deviation | units on CSDD scale |
| |||||||||||||
| Neuropsychiatric Inventory Nursing Home Version (NPI-NH) | The NPI-NH includes ten behavioral areas and two types of neurovegetative changes. Each of the 12 areas is scored on a subscale ranging from 0-12, where higher scores indicate greater neuropsychiatric symptomatology. A summary score is obtained from summing all 12 subscale scores. The summary score ranges from 0 - 144, where higher scores indicate greater neuropsychiatric symptomatology. Baseline means and SDs reported here do not account for clustering within facility. | Mean | Standard Deviation | units on NPH-NH scale |
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| 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 | Change in Cornell Scale for Depression in Dementia (CSDD) | The Cornell Scale for Depression in Dementia (CSDD) was used to measure depression. The CSDD is designed for the assessment of depression in older people with dementia who can at least communicate basic needs. The CSDD scale ranges from 0 to 38, with higher scores indicating higher levels of depression. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 are associated with absence of significant depressive symptoms. | Included patients with CSDD obtained within 4 months of start of study, leading to 28 analyzed for the control group (of 31) and 38 analyzed for the Daylight Intervention group (of 46). Baseline means and SDs reported here do not account for clustering within facility. | Posted | Mean | Standard Error | units on CSDD scale | A CSDD score was taken at the beginning of the 12-week study and once again at the end of the 12-week study. |
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| Secondary | Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) | The Neuropsychiatric Inventory Nursing Home Version (NPI-NH) was used to measure neuropsychiatric symptomatology. The NPI-NH is a scale designed for assessment of people with dementia residing in extended care facilities. The NPI-NH includes ten behavioral areas (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior) and two types of neurovegetative changes (sleep and nighttime behavior disorders, appetite and eating disorders). Each of the 12 areas is scored on a subscale ranging from 0-12, where higher scores indicate greater neuropsychiatric symptomatology. A summary score is obtained from summing all 12 subscale scores. The summary score ranges from 0 - 144, where higher scores indicate greater neuropsychiatric symptomatology. | Posted | Mean | Standard Error | Units on NPH-NH scale | A NPI-NH score was taken at the beginning of the 12-week study and once again at the end of the 12-week study. |
|
12 weeks
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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 | Control | At the 4 facilities in the control arm, participants received the usual care. During the period from 8:00 - 10:00 AM each day, the control group was taken to a similar sized area indoors (without daylight) for socialization under typical electrical lighting conditions. | 2 | 33 | 0 | 33 | 0 | 33 |
| EG001 | Daylight Intervention | At the 4 facilities in the active light intervention arm, staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study. Daylight Intervention: Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study. | 1 | 50 | 0 | 50 | 0 | 50 |
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Scheduling problems with baseline measures led to CSDD scores from health records being used for some participants with scoring dates that predated the start of the study by up to 4 months.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Kyle Konis, Ph.D | University of Southern California | (213) 740-2723 | kkonis@usc.edu |
| Dec 21, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D003863 | Depression |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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