Pilot Study to Examine Health Effects of Daylight Exposure on Dementia Patients

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT03483896
• Collaborator: (none)
• Enrollment: 83
• Locations: 8
• Arms: 2
• Actual Duration (Months): 4.1
• Patients Per Site: 10.4
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia; Depression; Behavior Disorders	Other: Daylight Intervention	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pilot Study to Examine the Effects of Indoor Daylight Exposure on Depression and Other Neuropsychiatric Symptoms in People Living With Dementia in Long Term Care Facilities
• Actual Study Start Date: Jan 30, 2017
• Actual Primary Completion Date: May 10, 2017
• Actual Study Completion Date: Jun 5, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Active Comparator: 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.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Change in Cornell Scale for Depression in Dementia (CSDD) [A CSDD score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.]

   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.

Secondary Outcome Measures

1. Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Residents were recruited according to the trial inclusion criteria: 1) Alzheimer's disease and related dementias (ADRD) diagnosis, 2) no physical co-morbidities that precluded participation in the daily group intervention, and 3) a Mini-Mental State Exam (MMSE) score of 10 or higher

Exclusion Criteria:

• physical co-morbidities that precluded participation in the daily group intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alhambra Dementia Care	Alhambra	California	United States	91801
2	Sierra Vista Memory Care Community	Azusa	California	United States	91702
3	Calabasas Memory Care Community	Calabasas	California	United States	91302
4	Costa Mesa Dementia Care	Costa Mesa	California	United States	92627
5	Los Angeles Dementia Care (Beverly Place)	Los Angeles	California	United States	90048
6	Redondo Beach Dementia Care (Beach Cities)	Redondo Beach	California	United States	90277
7	San Juan Capistrano Memory Care Community	San Juan Capistrano	California	United States	92675
8	Tustin Hacienda Memory Care Community	Tustin	California	United States	92780

Sponsors and Collaborators

• University of Southern California

Investigators

• Principal Investigator: Kyle Konis, Ph.D, University of Southern California

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 10, 2016

More Information

Publications

None provided.

• Responsible Party: Kyle Konis, Assistant Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT03483896
• Other Study ID Numbers: UP-16-00487
• First Posted: Mar 30, 2018
• Last Update Posted: Mar 29, 2019
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia; Depression; Mental Disorders

Study Results

Participant Flow

Arm/Group Title	Control	Daylight Intervention
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	33	50
COMPLETED	31	46
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	Control	Daylight Intervention	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	31	46	77
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	84.7 (7.3)	85.6 (6.9)	85.3 (7.0)
Sex: Female, Male (Count of Participants)
Female	25 80.6%	31 67.4%	56 72.7%
Male	6 19.4%	15 32.6%	21 27.3%
Race/Ethnicity, Customized (Count of Participants)
White race	29 93.5%	42 91.3%	71 92.2%
Non-white race	2 6.5%	4 8.7%	6 7.8%
Region of Enrollment (participants) [Number]
United States	31 100%	46 100%	77 100%
Cornell Scale for Depression in Dementia (CSDD) (units on CSDD scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on CSDD scale]	4.4 (4.5)	5.0 (5.4)	4.4 (4.5)
Neuropsychiatric Inventory Nursing Home Version (NPI-NH) (units on NPH-NH scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on NPH-NH scale]	16.3 (14.5)	16.0 (19.1)	16.1 (17.3)

Outcome Measures

1. Primary Outcome

Title	Change in Cornell Scale for Depression in Dementia (CSDD)
Description	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.
Time Frame	A CSDD score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control	Daylight Intervention
Arm/Group Description	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.	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.
Measure Participants	28	36
Mean (Standard Error) [units on CSDD scale]	1.5 (1.0)	-2.0 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Daylight Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH)
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Daylight Intervention
Arm/Group Description	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.	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.
Measure Participants	31	46
Mean (Standard Error) [Units on NPH-NH scale]	3.1 (3.2)	-2.8 (2.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Daylight Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Control		Daylight Intervention
Arm/Group Description	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.		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.
All Cause Mortality
	Control		Daylight Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/33 (6.1%)		1/50 (2%)
Serious Adverse Events
	Control		Daylight Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Control		Daylight Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/50 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.