Person-Environment Fit for Persons With Dementia
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
- Dementia Alzheimers
- Alzheimer Disease
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 60-99, 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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Harmony at HOME |
Participants in this group will receive the Harmony at HOME intervention. |
|
Active Comparator National Institute on Aging Program |
Participants in this group will receive the National Institute on Aging education. |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT05722743
- Status
- Recruiting
- Sponsor
- Elizabeth K Rhodus