Trial Outcomes & Findings for Pilot Study to Examine Health Effects of Daylight Exposure on Dementia Patients (NCT NCT03483896)
NCT ID: NCT03483896
Last Updated: 2019-03-29
Results Overview
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.
COMPLETED
NA
83 participants
A CSDD score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.
2019-03-29
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
50
|
|
Overall Study
COMPLETED
|
31
|
46
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Control
n=31 Participants
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
n=46 Participants
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.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Ethnicity · Non-white race
|
2 Participants
n=31 Participants
|
4 Participants
n=46 Participants
|
6 Participants
n=77 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=31 Participants
|
46 participants
n=46 Participants
|
77 participants
n=77 Participants
|
|
Age, Continuous
|
84.7 years
STANDARD_DEVIATION 7.3 • n=31 Participants
|
85.6 years
STANDARD_DEVIATION 6.9 • n=46 Participants
|
85.3 years
STANDARD_DEVIATION 7.0 • n=77 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=31 Participants
|
31 Participants
n=46 Participants
|
56 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=31 Participants
|
15 Participants
n=46 Participants
|
21 Participants
n=77 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White race
|
29 Participants
n=31 Participants
|
42 Participants
n=46 Participants
|
71 Participants
n=77 Participants
|
|
Cornell Scale for Depression in Dementia (CSDD)
|
4.4 units on CSDD scale
STANDARD_DEVIATION 4.5 • n=28 Participants • 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.
|
5.0 units on CSDD scale
STANDARD_DEVIATION 5.4 • n=38 Participants • 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.
|
4.4 units on CSDD scale
STANDARD_DEVIATION 4.5 • n=66 Participants • 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.
|
|
Neuropsychiatric Inventory Nursing Home Version (NPI-NH)
|
16.3 units on NPH-NH scale
STANDARD_DEVIATION 14.5 • n=31 Participants
|
16.0 units on NPH-NH scale
STANDARD_DEVIATION 19.1 • n=46 Participants
|
16.1 units on NPH-NH scale
STANDARD_DEVIATION 17.3 • n=77 Participants
|
PRIMARY outcome
Timeframe: A CSDD score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.Population: 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.
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.
Outcome measures
| Measure |
Control
n=28 Participants
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
n=36 Participants
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.
|
|---|---|---|
|
Change in Cornell Scale for Depression in Dementia (CSDD)
|
1.5 units on CSDD scale
Standard Error 1.0
|
-2.0 units on CSDD scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Control
n=31 Participants
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
n=46 Participants
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.
|
|---|---|---|
|
Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH)
|
3.1 Units on NPH-NH scale
Standard Error 3.2
|
-2.8 Units on NPH-NH scale
Standard Error 2.9
|
Adverse Events
Control
Daylight Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Kyle Konis, Ph.D
University of Southern California
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place