NCT03483896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2017

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 29, 2019

Completed
Last Updated

March 29, 2019

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

March 21, 2018

Results QC Date

May 15, 2018

Last Update Submit

December 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (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.

Study Arms (2)

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.

Other: Daylight Intervention

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Alhambra Dementia Care

Alhambra, California, 91801, United States

Location

Sierra Vista Memory Care Community

Azusa, California, 91702, United States

Location

Calabasas Memory Care Community

Calabasas, California, 91302, United States

Location

Costa Mesa Dementia Care

Costa Mesa, California, 92627, United States

Location

Los Angeles Dementia Care (Beverly Place)

Los Angeles, California, 90048, United States

Location

Redondo Beach Dementia Care (Beach Cities)

Redondo Beach, California, 90277, United States

Location

San Juan Capistrano Memory Care Community

San Juan Capistrano, California, 92675, United States

Location

Tustin Hacienda Memory Care Community

Tustin, California, 92780, United States

Location

MeSH Terms

Conditions

DementiaDepressionMental Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersBehavioral SymptomsBehavior

Limitations and 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.

Results Point of Contact

Title
Prof. Kyle Konis, Ph.D
Organization
University of Southern California

Study Officials

  • Kyle Konis, Ph.D

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2018

First Posted

March 30, 2018

Study Start

January 30, 2017

Primary Completion

May 10, 2017

Study Completion

June 5, 2017

Last Updated

March 29, 2019

Results First Posted

March 29, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations