Environmental Design for Behavioral Regulation in People With Dementia

Not Applicable

Completed

• Conditions: Alzheimer Disease
• Interventions: Behavioral: Placebo; Behavioral: Individual Environmental Design; Behavioral: Standard Environmental Design

• Registration Number: NCT04555616
• Lead Sponsor: Elizabeth K Rhodus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Study Start: 2021-01-25
• Primary Completion: 2021-10-13
• Study Completion: 2021-10-13
• Results First Submitted: 2022-11-22
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-19
• Last Update Submitted: 2023-03-19
• Results First Posted: 2023-04-12
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	Alzheimer's disease patients and caregivers.
Individualized Environmental Design Protocol	Individual Environmental Design	Alzheimer's disease patients and caregivers.
Standard Environmental Design	Standard Environmental Design	Alzheimer's disease patients and caregivers.

Primary Outcome Measures

Name	Time	Method
Success Rate of Adherence	6 weeks	Percentage of participants who had 75% adherence to the protocol based on visits and journals.

Secondary Outcome Measures

Name	Time	Method
Change in Behavior	10 weeks (at baseline, 6 weeks and the 4 week follow up)	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.
Change in Occupational Performance	10 weeks (at baseline, 6 weeks and the 4 week follow up)	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.

Trial Locations

Locations (1)

University of Kentcuky; 🇺🇸 Lexington, Kentucky, United States