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

Primary Purpose

Dementia, Depression, Behavior Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daylight Intervention
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dementia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alhambra Dementia Care
  • Sierra Vista Memory Care Community
  • Calabasas Memory Care Community
  • Costa Mesa Dementia Care
  • Los Angeles Dementia Care (Beverly Place)
  • Redondo Beach Dementia Care (Beach Cities)
  • San Juan Capistrano Memory Care Community
  • Tustin Hacienda Memory Care Community

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Daylight Intervention

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 21, 2018
Last Updated
December 21, 2018
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT03483896
Brief Title
Pilot Study to Examine Health Effects of Daylight Exposure on Dementia Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
May 10, 2017 (Actual)
Study Completion Date
June 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Depression, Behavior Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
Daylight Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Daylight Intervention
Intervention Description
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.
Primary Outcome Measure Information:
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.
Secondary Outcome Measure Information:
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Konis, Ph.D
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alhambra Dementia Care
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
Sierra Vista Memory Care Community
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Calabasas Memory Care Community
City
Calabasas
State/Province
California
ZIP/Postal Code
91302
Country
United States
Facility Name
Costa Mesa Dementia Care
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Los Angeles Dementia Care (Beverly Place)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Redondo Beach Dementia Care (Beach Cities)
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
San Juan Capistrano Memory Care Community
City
San Juan Capistrano
State/Province
California
ZIP/Postal Code
92675
Country
United States
Facility Name
Tustin Hacienda Memory Care Community
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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