Status:
COMPLETED
Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers
Lead Sponsor:
Elizabeth K Rhodus
Collaborating Sponsors:
National Institute on Aging (NIA)
Emory University
Conditions:
Alzheimer Disease
Dementia
Eligibility:
All Genders
21-99 years
Phase:
NA
Brief Summary
There is a need for caregiver-initiated and -implemented non-pharmacological interventions directly to and for the person with dementia, including environmental assessment and modification, as first-l...
Detailed Description
Behavioral disruptions by individuals with Alzheimer's disease and related dementias (ADRD) are reported in nearly 90% of persons living with ADRD. Such behavioral and psychological symptoms of dement...
Eligibility Criteria
Inclusion
- Inclusion and excluded groups: Recruitment and enrollment will be inclusive of all groups living within rural, Appalachia Kentucky who are over the age of 21.
- Participants must meet all inclusion criteria in order to participate in the study:
- Caregiver for Participant with Dementia:
- Men or women aged 21-99, inclusive.
- Willingness and ability to participate in trial and implement recommended intervention strategies throughout the duration of the study.
- Access to and ability to use video technology (Zoom) for telehealth visits.
- English speaking, able to read and write.
- Ability to retrieve and return mail.
- Participants with Dementia:
- Men or women aged 65-99, inclusive.
- Living at home in the community with one primary caregiver.
- 3\. Diagnosis of Alzheimer's disease as primary dementia type of moderate to severe stages (confirmed by Clinical Dementia Rating Scale score of 1.0+)
- No change in medical condition for one month prior to screening visit
- No change in medications for 4 weeks prior to screening visit.
- If on psychotropic medication, the participant is at a point where dosage and treatment are stabilized for the duration of the study.
- Physically acceptable for this study as confirmed by medical history, physical exam, and clinical tests completed by medical professional (MD, APRN, PA or OT).
- 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 participant throughout duration of study.
- Caregiver access to and ability to use video technology (Zoom, Skype, video call) which resembles telehealth visits.
- Contact with University of Kentucky Alzheimer's Disease Center (UKADC) or Kentucky Neuroscience Institute (KNI) medical provider within 12 months of study recruitment.
- Not actively participating in physical/occupational therapy throughout duration of study.
- Exclusion Criteria
- Caregiver for Participant with Dementia:
- Diagnosis of mild cognitive impairment or dementia.
- Severe psychological stress or active state of psychiatric conditions (severe depression, mania, hallucinations/delusions).
- 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.
- Skin lesions or skin abnormalities throughout upper extremities.
- Allergies related to lotion or fragrance.
- 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.
- Diagnosis or concern of epilepsy.
- Use of any investigational agents or devices within 30 days prior to screening.
- Major infection within 4 weeks prior to the Baseline Visit.
- Physically unacceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.
Exclusion
Key Trial Info
Start Date :
January 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05202223
Start Date
January 15 2022
End Date
December 8 2022
Last Update
December 29 2023
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40506