This trial will assess feasibility of a non-pharmacological intervention for persons living with Alzheimer's disease and related dementias (ADRD) to improve behavioral and psychiatric symptoms of dementia and functional performance. Using a two-arm, prospective randomized controlled trial, 38 dyads (person with ADRD and caregiver) will complete an 8-week telehealth occupational therapy intervention provided via Zoom with caregivers and persons with dementia or receive an active control with 8 telehealth sessions to discuss publicly available caregiver education with a non-clinical research assistant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
84
The Harmony at HOME (Help Online Modifying the Environment) intervention builds on prior successful foundations of dementia care interventions with a novel approach combining remote implementation, antecedent education, and home environment intervention. The intervention will teach caregivers how to 1) assess the home environment as an antecedent to behavior for the person with ADRD, and 2) design and implement individualized environmental modification through an environmental cueing approach to address the needs of the person with ADRD in a supportive environment.
Standard of care will address behaviors and psychiatric symptoms of dementia (BPSD) for persons with ADRD, as recommended by their medical provider. Caregivers will receive training regarding home safety via a home safety handout based on National Institutes on Aging "Home Safety and Alzheimer's Disease" webpage.
University of Kentucky
Lexington, Kentucky, United States
Change in patient performance as measured by Canadian Occupational Performance Measure (COPM)
Criterion-referenced interview of patient performance with caregiver The COPM is a reliable and validated measure of performance in primary daily activities (self-care, leisure, productivity) with dyad-caregiver rated of performance and satisfaction. Scores are determined on a likert scale of 1-10 with 1 being lowest and 10 indicating highest of the topic of the question.
Time frame: 13weeks (baseline, post-intervention, follow up)
Caregiver satisfaction of patient performance [Feasibility]
The primary outcome analysis is the feasibility of implementation as measured by caregiver satisfaction. The Canadian Occupational Performance Measure will measure caregiver satisfaction of patient performance, high scores indicate higher levels of satisfaction. Range 0-10.
Time frame: 13 weeks (baseline, post intervention, follow up)
Zarit Caregiver Burden Scale
22-item survey, caregiver rates self-perceived level of burden on 5-point Likert scale. The social context of the person with ADRD will be described through analysis of caregiver demographics and rate of caregiver burden measured. Higher scores indicate greater burden. Range of 0-88 points. A score of 17 or more was considered high burden.
Time frame: 13 weeks (baseline, post intervention, follow up)
Neuropsychiatric Inventory Questionnaire (NPI-Q)
The NPI-Q is commonly used as an assessment of behavioral and psychiatric symptoms of dementia in older adults diagnosed with mild cognitive impairment or dementia, internationally, with high reliability and validity. Assessment includes 12 behavioral and psychiatric domains which are rated by caregiver as present or absent (yes/no). Caregivers further rate severity of present behavioral domains. The severity score is summed to yield a total as a measure of BPSD burden. Higher scores indicate higher levels of behavior symptom severity and/or distress. Range 0-36
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Time frame: 13 weeks (baseline, post intervention, follow up)
Functional Behavior Profile (FBP)
Criterion-referenced survey completed by caregiver. The FBP has been established as a reliable and valid measure of task performance, social interaction, and problem solving with adults with ADRD. Item responses range from 0 to 4, with higher scores indicating better performance (maximum score 108).
Time frame: 13 weeks (baseline, post intervention, follow up)