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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 21 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT04555616
Status
Completed
Sponsor
Elizabeth K Rhodus

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.