Environmental Design for Behavioral Regulation in People With Dementia
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Jan 2021
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2020
CompletedFirst Posted
Study publicly available on registry
September 21, 2020
CompletedStudy Start
First participant enrolled
January 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2021
CompletedResults Posted
Study results publicly available
April 12, 2023
CompletedApril 12, 2023
March 1, 2023
9 months
September 14, 2020
November 22, 2022
March 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success Rate of Adherence
Percentage of participants who had 75% adherence to the protocol based on visits and journals.
6 weeks
Secondary Outcomes (2)
Change in Occupational Performance
10 weeks (at baseline, 6 weeks and the 4 week follow up)
Change in Behavior
10 weeks (at baseline, 6 weeks and the 4 week follow up)
Study Arms (3)
Control Group
PLACEBO COMPARATORAlzheimer's disease patients and caregivers.
Standard Environmental Design
EXPERIMENTALAlzheimer's disease patients and caregivers.
Individualized Environmental Design Protocol
EXPERIMENTALAlzheimer's disease patients and caregivers.
Interventions
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.
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.
Participants' caregivers will receive a set script of placebo modifications.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elizabeth K Rhoduslead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of Kentcuky
Lexington, Kentucky, 40536, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elizabeth Rhodus
- Organization
- University of Kentucky
Study Officials
- STUDY DIRECTOR
Gregory Jicha, MD-PhD
University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 14, 2020
First Posted
September 21, 2020
Study Start
January 25, 2021
Primary Completion
October 13, 2021
Study Completion
October 13, 2021
Last Updated
April 12, 2023
Results First Posted
April 12, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share