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