Environmental Design for Behavioral Regulation in People With Dementia

Elizabeth K Rhodus

Status: Completed

Conditions: Alzheimer Disease

Treatments: Behavioral: Standard Environmental Design; Behavioral: Individual Environmental Design; Behavioral: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04555616

61291

T32AG057461 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Alzheimer's disease patients and caregivers.

Treatment:

Behavioral: Placebo

Standard Environmental Design

Experimental group

Description:

Alzheimer's disease patients and caregivers.

Treatment:

Behavioral: Standard Environmental Design

Individualized Environmental Design Protocol

Experimental group

Description:

Alzheimer's disease patients and caregivers.

Treatment:

Behavioral: Individual Environmental Design