Clinical trial NCT05722743: Person-Environment Fit for Persons With Dementia
Official title: Improving Person-Environment Fit of Community-Residing Older Adults With Dementia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia Alzheimers
Alzheimer Disease
Keywords: Behavioral
Occupational therapy
Alzheimer's disease and related dementias
Telehealth
Caregiver
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-02-10
Enrollment: 76
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Primary outcomes:
measure: Change in patient performance as measured by Canadian Occupational Performance Measure (COPM)
timeFrame: 13weeks (baseline, post-intervention, follow up)
measure: Caregiver satisfaction of patient performance [Feasibility]
timeFrame: 13 weeks (baseline, post intervention, follow up)
Secondary outcomes:
measure: Zarit Caregiver Burden Scale
timeFrame: 13 weeks (baseline, post intervention, follow up)
measure: Neuropsychiatric Inventory Questionnaire (NPI-Q)
timeFrame: 13 weeks (baseline, post intervention, follow up)
measure: Functional Behavior Profile (FBP)
timeFrame: 13 weeks (baseline, post intervention, follow up)
Other outcomes:
measure: Home Occupational Environment Assessment (HOEA)
timeFrame: 1 time (baseline)
measure: Adult Sensory Profile (ASP)
timeFrame: 1 time (baseline)
measure: Clinical Dementia Rating Scale (CDR-SUM)
timeFrame: 1 time (baseline)
measure: Digital Biomarker of psychophysiological response to environment: heart rate variability
timeFrame: Device worn by patient for 7 consecutive days
measure: Digital Biomarker of psychophysiological response to environment: electrodermal activity
timeFrame: Device worn by patient for 7 consecutive days
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Elizabeth Rhodus, PhD
role: PRINCIPAL_INVESTIGATOR
References: