NCT04555616

Environmental Design for Behavioral Regulation in People With Dementia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Elizabeth K Rhodus · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Individuals with dementia present with changes in behaviors throughout the continuum of cognitive decline. Environmental features may be influential in behavioral regulation. The purpose of this study is to assess the feasibility of environmental design protocols in older adults with dementia and their caregivers. Thirty subjects with moderate to severe Alzheimer's disease as primary dementia type, and their caregivers, will be randomly assigned to one of three arms: standard care; standard environmental design protocol; or personalized environmental design protocol.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
BEHAVIORAL	Standard Environmental Design	Participants' caregivers will receive set script of physical environmental modifications (i.e., declutter living space, reduce background noise, increase natural light), and social environment training script will include caregiving techniques: training for calming demeanor (emotional contagion), needs-driven care to decrease behavioral disruption, and accepting and accommodating approach to behavioral disruption. A pre-selected sensory stimulation kit will be provided to each participants' caregiver for administration throughout the day.
BEHAVIORAL	Individual Environmental Design	Participants' caregivers will receive set script of physical environmental modifications and social environment training script in a standard protocol. Following initial assessments, individualized sensory stimulation kits will be developed using subjects' preferred sensory stimuli (as determined by the Adult Sensory Profile assessment and informant report) and will be provided via caregiver administration throughout the day to promote maintained behavioral regulation.
BEHAVIORAL	Placebo	Participants' caregivers will receive a set script of placebo modifications.

Timeline

• Start date: 2021-01-25
• Primary completion: 2021-10-13
• Completion: 2021-10-13
• First posted: 2020-09-21
• Last updated: 2023-04-12
• Results posted: 2023-04-12

Locations

1 site across 1 country: United States