Environmental Design for Behavioral Regulation in People With Dementia

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 Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Behavioral: Placebo; Behavioral: Standard Environmental Design; Behavioral: Individual Environmental Design

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentcuky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men or women aged 21-90, inclusive.
• Living at home in the community with one primary caregiver.
• Diagnosis of Alzheimer's disease as primary dementia type of moderate to severe stages
• Stable medical condition for one month prior to screening visit
• Stable medications for 4 weeks prior to screening visit
• Caregiver report of challenges related to behaviors within 4 weeks of study enrollment
• Caregiver willing to participant throughout duration of study

Exclusion Criteria:

• Unstable medical conditions for 3 months prior to screening
• Wheelchair or bed bound.
• Residence in skilled nursing facility or facility-based care.
• Skin lesions or skin abnormalities throughout upper extremities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Alzheimer's disease patients and caregivers.	Behavioral: Placebo; Participants' caregivers will receive a set script of placebo modifications.
Experimental: Standard Environmental Design; Alzheimer's disease patients and caregivers.	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.
Experimental: Individualized Environmental Design Protocol; Alzheimer's disease patients and caregivers.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate of Adherence	Percentage of participants who had 75% adherence to the protocol based on visits and journals.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Occupational Performance	Occupational performance will be measured using the Canadian Occupational Performance Measure (COPM) at baseline, post-intervention and the 4-week follow up. Scores range from 0-10; higher scores indicate (increased) occupational performance.	10 weeks (at baseline, 6 weeks and the 4 week follow up)
Change in Behavior	Behavior will be measured using the Neuropsychiatric Inventory (NPI-Q) at baseline, post-intervention and the 4-week follow up. Scores range from 1-36; higher scores indicate higher behavior severity.	10 weeks (at baseline, 6 weeks and the 4 week follow up)

Collaborators and Investigators

• Sponsor: Elizabeth K Rhodus
• Collaborators: National Institute on Aging (NIA)
• Investigators: Study Director: Gregory Jicha, MD-PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): October 13, 2021
• Study Completion (Actual): October 13, 2021

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: March 19, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Occupational therapy; environment
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: 61291; T32AG057461 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No