N/A
N=80
Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers
Alzheimer Disease · Dementia · Brain Diseases · Central Nervous System Diseases · Nervous System Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05202223 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change in Caregiver Mastery — 12.6; 13; 13 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Harmony at HOME (H@H) (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Elizabeth K Rhodus
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Caregiver Mastery |
12.6; 13; 13 | — |
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-line treatments for behavioral and psychological symptoms of dementia (BPSD) in persons living with dementia (PLWD). Delivered via telehealth, Harmony at HOME (H@H) aims to train caregivers of persons with moderate to severe ADRD in the skills of assessing and modifying the home environment to promote "person-environment fit," a concept that posits that the ability to access features within a built environment (e.g. bathroom, stairs,) or that factors within the environment itself (lighting, noise level, temperature), especially when linked with individualized social support, contribute to or even shape behavior.
In addition to the intervention, the first 10 caregiver participants to enroll will also be invited to participate in two focus groups that will be facilitated during and after the intervention. The first focus group focuses on experiences as a dementia caregiver in rural areas. The second focus group focuses on providing feedback regarding caregivers' perceptions, acceptability, and usefulness of the H@H intervention. These focus groups will be conducted as structured interviews with open-ended questions that encourage participants to share their experiences.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05202223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.