Person-Environment Fit for Persons With Dementia

Elizabeth K Rhodus

Status

Completed

Conditions

Alzheimer Disease

Dementia Alzheimers

Treatments

Behavioral: Harmony at HOME

Behavioral: National Institute on Aging Program

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05722743

1K23AG075262-01A1 (U.S. NIH Grant/Contract)

72893

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

All

Ages

21 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.