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Completed NCT05722743

Person-Environment Fit for Persons With Dementia

Conditions: Dementia Alzheimers, Alzheimer Disease

Sex: All
Ages: 21 Years – 99 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 84
Sponsor: Elizabeth K Rhodus

Location: University of Kentucky Lexington Kentucky

Summary

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05722743). StuddyBuddy aggregates publicly available trial information.