CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Standard Environmental Design +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04555616
NCT04555616N/ACompleted

Environmental Design for Behavioral Regulation in People With Dementia

Elizabeth K Rhodus·interventional·Posted Sep 21, 2020·Updated Apr 12, 2023

In Brief

A clinical study evaluating Standard Environmental Design, Individual Environmental Design, and 1 other intervention for Alzheimer Disease. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 21, 2020
Enrollment StartJan 25, 2021
Primary CompletionOct 13, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.8 years ago

Interventions

Standard Environmental Designbehavioral

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.

Individual Environmental Designbehavioral

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.

Placebobehavioral

Participants' caregivers will receive a set script of placebo modifications.