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Not Yet Recruiting NCT05722743

Person-Environment Fit for Persons With Dementia

Conditions: Dementia Alzheimers, Alzheimer Disease

Sex: All
Ages: 21 Years – 99 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 76
Sponsor: Elizabeth K Rhodus

Location: United States

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 DementiaMen 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 DementiaMen 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 DementiaUnstable 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 medicationsDiagnosis 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.