Start: January 2022
End: December 2022
What Is This Study About?
This study, called Harmony at Home, will examine the effectiveness of an online caregiver training program to reduce caregiver stress and improve caregiver satisfaction and sense of control. The program teaches caregivers to make changes in their home environment (e.g., lighting, noise level, temperature) and access features (e.g., stairs, bathrooms) to improve access and support positive behavior changes in the person living with dementia. Caregivers of people with moderate-to-severe dementia living in the Appalachian region of rural Kentucky will receive training, using videoconferencing, from an occupational therapist once a week for six weeks. At the start and end of the training period, and at a one-month follow-up, participants will complete questionnaires to report their sense of personal control, caregiver burden, stress, and satisfaction, as well as behavioral symptoms of the person living with dementia.
Do I Qualify To Participate in This Study?
- Access and ability to use video technology for telehealth visits
- Able to speak, read, and write in English
- Able to retrieve and return mail
Participants with Alzheimer's disease:
- Age 65 or older
- Living at home with a primary caregiver
- Diagnosis of Alzheimer's disease with a Clinical Dementia Rating Scale score > 1
- No changes in any medical condition for at least one month prior to screening visit
- No changes in medications within four weeks prior to study screening
- If taking psychotropic medication, dosage and treatment must be stable for the duration of the study
- Overall good physical health, based on a physical exam and laboratory tests
- Able to hear, see, smell, touch, and taste, with or without sensory aids
- Challenging behaviors, as reported by the caregiver, within four weeks of starting study
- Previous contact with a doctor or other medical provider at the University of Kentucky Alzheimer's Disease Research Center or the Kentucky Neuroscience Institute within one year of starting study
Must NOT have:
- Diagnosis of mild cognitive impairment or dementia
- Severe psychological stress or current psychiatric conditions (e.g., severe depression, mania, hallucinations, or delusions)
Participants with Alzheimer's disease:
- Any serious or unstable medical conditions within one month prior to screening visit (e.g., poorly controlled blood pressure, diabetes, current cancer diagnosis, major infection, breathing problems)
- Diagnosis of serious sensory altering disorder that could interfere with study (e.g., macular degeneration, legal blindness, total deafness, severe peripheral neuropathy, loss of smell)
- Living in a nursing home or other long-term care facility
- Wheelchair or bed bound
- Skin lesions or skin abnormalities on hands or arms
- Allergies to lotion or fragrance
- Physically violent behaviors, as reported by caregiver
- Started an antipsychotic medication within four weeks of study screening
- Major depression or other mental illness such as schizophrenia, bipolar disorder, personality disorders, or substance abuse within the past year
- Seizures with or without a diagnosis of epilepsy
- Participation in another clinical trial or treatment with any experimental drug within one month prior to study screening
- Major infection within four weeks prior to starting the study
- Participation, expected or unexpected, in physical or occupational therapy during study duration
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Elizabeth Rhodus, PhD
Allison Gibson, PhD
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Allison Gibson
Source: ClinicalTrials.gov ID: NCT05202223