Person-Environment Fit for Persons With Dementia
- Conditions
- Alzheimer DiseaseDementia Alzheimers
- Interventions
- Behavioral: National Institute on Aging ProgramBehavioral: Harmony at HOME
- Registration Number
- NCT05722743
- Lead Sponsor
- Elizabeth K Rhodus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 76
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description National Institute on Aging Program National Institute on Aging Program Participants in this group will receive the National Institute on Aging education. Harmony at HOME Harmony at HOME Participants in this group will receive the Harmony at HOME intervention.
- Primary Outcome Measures
Name Time Method Caregiver satisfaction of patient performance [Feasibility] 13 weeks (baseline, post intervention, follow up) The primary outcome analysis is the feasibility of implementation as measured by caregiver satisfaction. The Canadian Occupational Performance Measure will measure caregiver satisfaction of patient performance, high scores indicate higher levels of satisfaction. Range 0-10.
Change in patient performance as measured by Canadian Occupational Performance Measure (COPM) 13weeks (baseline, post-intervention, follow up) Criterion-referenced interview of patient performance with caregiver The COPM is a reliable and validated measure of performance in primary daily activities (self-care, leisure, productivity) with dyad-caregiver rated of performance and satisfaction. Scores are determined on a likert scale of 1-10 with 1 being lowest and 10 indicating highest of the topic of the question.
- Secondary Outcome Measures
Name Time Method Zarit Caregiver Burden Scale 13 weeks (baseline, post intervention, follow up) 22-item survey, caregiver rates self-perceived level of burden on 5-point Likert scale. The social context of the person with ADRD will be described through analysis of caregiver demographics and rate of caregiver burden measured. Higher scores indicate greater burden. Range of 0-88 points. A score of 17 or more was considered high burden.
Neuropsychiatric Inventory Questionnaire (NPI-Q) 13 weeks (baseline, post intervention, follow up) The NPI-Q is commonly used as an assessment of behavioral and psychiatric symptoms of dementia in older adults diagnosed with mild cognitive impairment or dementia, internationally, with high reliability and validity. Assessment includes 12 behavioral and psychiatric domains which are rated by caregiver as present or absent (yes/no). Caregivers further rate severity of present behavioral domains. The severity score is summed to yield a total as a measure of BPSD burden. Higher scores indicate higher levels of behavior symptom severity and/or distress. Range 0-36
Functional Behavior Profile (FBP) 13 weeks (baseline, post intervention, follow up) Criterion-referenced survey completed by caregiver. The FBP has been established as a reliable and valid measure of task performance, social interaction, and problem solving with adults with ADRD. Item responses range from 0 to 4, with higher scores indicating better performance (maximum score 108).
Trial Locations
- Locations (1)
University of Kentucky
🇺🇸Lexington, Kentucky, United States