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Person-Environment Fit for Persons With Dementia

Recruiting
21 - 99 years of age
Both
Phase N/A

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Overview

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

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 details

Dementia Alzheimers, Alzheimer Disease

NCT05722743

Elizabeth K Rhodus

14 May 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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