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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

Participants with Dementia - Men or women aged 65-99, inclusive. - Living at home in the community with one primary caregiver. - Diagnosis or probably diagnosis of dementia (confirmed by Clinical Dementia Rating Scale score of 1.0+) - If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study. - Functional sensory abilities with or without aids (hearing, vision, smell, touch, taste) - Caregiver report of challenges related to behaviors within 4 weeks of study enrollment. - Caregiver willing to participate throughout duration of study. - Contact with University of Kentucky Alzheimer's Disease Research Center or Kentucky Neuroscience Institute medical provider within 12 months of study recruitment. Inclusion Criteria: Caregiver for Participants with Dementia - Men or women aged 21-99, inclusive. - Willingness to participate in study and implement recommended data collection tools. - English speaking, able to read and write. - Ability to retrieve and send mail.

Exclusion Criteria

Participants with Dementia - Unstable medical conditions within one month prior to screening visit such as poorly controlled blood pressure, diabetes, current cancer diagnosis, or breathing problems, etc. - Wheelchair or bed bound. - Residence in skilled nursing facility or facility-based care. - Caregiver report of physically violent behaviors. - Initiation of antipsychotic medication within 4 weeks prior to screening or unpredictable use of such medications - Diagnosis of profound or total sensory altering disorders including macular degeneration, legal blindness, total deafness, severe peripheral neuropathy, anosmia. - Major depression in past 12 months (DSM-IV criteria), major mental illness such as schizophrenia, bipolar disorder, personality disorders, or recent (in past 12 months) alcohol or substance abuse. - Major infection within 4 weeks prior to the Baseline Visit. Exclusion Criteria: Caregiver for Participant with Dementia: • Diagnosis of mild cognitive impairment or dementia.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Harmony at HOME
Participants in this group will receive the Harmony at HOME intervention.
  • Behavioral: Harmony at HOME
    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.
Active Comparator
National Institute on Aging Program
Participants in this group will receive the National Institute on Aging education.
  • Behavioral: National Institute on Aging Program
    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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Elizabeth Rhodus, PhD
859-257-5562
elizabeth.rhodus@uky.edu

More Details

NCT ID
NCT05722743
Status
Recruiting
Sponsor
Elizabeth K Rhodus

Study Contact

Elizabeth Rhodus, PhD
8592575562
elizabeth.rhodus@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.