Environmental Design for Behavioral Regulation in People With Dementia
NCT ID: NCT04555616
Last Updated: 2023-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-01-25
2021-10-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control Group
Alzheimer's disease patients and caregivers.
Placebo
Participants' caregivers will receive a set script of placebo modifications.
Standard Environmental Design
Alzheimer's disease patients and caregivers.
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.
Individualized Environmental Design Protocol
Alzheimer's disease patients and caregivers.
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.
Interventions
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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.
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.
Placebo
Participants' caregivers will receive a set script of placebo modifications.
Eligibility Criteria
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Inclusion Criteria
* 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
* Wheelchair or bed bound.
* Residence in skilled nursing facility or facility-based care.
* Skin lesions or skin abnormalities throughout upper extremities.
21 Years
90 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Elizabeth K Rhodus
OTHER
Responsible Party
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Elizabeth K Rhodus
Assistant Professor
Principal Investigators
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Gregory Jicha, MD-PhD
Role: STUDY_DIRECTOR
University of Kentucky
Locations
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University of Kentcuky
Lexington, Kentucky, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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61291
Identifier Type: -
Identifier Source: org_study_id
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