Environmental Design for Behavioral Regulation in People With Dementia

Alzheimer Disease Clinical Trial

Official title:

Environmental Design for Behavioral Regulation in People With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555616
• Other study ID #: 61291
• Secondary ID: T32AG057461
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: October 13, 2021

Study information

• Verified date: March 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 13, 2021
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kentcuky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth K Rhodus	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate of Adherence	Percentage of participants who had 75% adherence to the protocol based on visits and journals.	6 weeks
Secondary	Change in Occupational Performance	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.	10 weeks (at baseline, 6 weeks and the 4 week follow up)
Secondary	Change in Behavior	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.	10 weeks (at baseline, 6 weeks and the 4 week follow up)