Environmental Design for Behavioral Regulation in People With Dementia

Study Overview
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Brief Summary
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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.

Official Title
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Environmental Design for Behavioral Regulation in People With Dementia

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Behavioral: Standard Environmental Design
* Behavioral: Individual Environmental Design
* Behavioral: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Alzheimer's disease patients and caregivers. | Behavioral: Placebo<br>* Participants' caregivers will receive a set script of placebo modifications.<br>|
| Experimental: Standard Environmental Design<br>Alzheimer's disease patients and caregivers. | Behavioral: Standard Environmental Design<br>* 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.<br>|
| Experimental: Individualized Environmental Design Protocol<br>Alzheimer's disease patients and caregivers. | Behavioral: Individual Environmental Design<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate of Adherence | Percentage of participants who had 75% adherence to the protocol based on visits and journals. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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environment, Occupational therapy