Start: February 1, 2017
End: August 2021
Enrollment: 150
What Is This Study About?
This study will test the effectiveness of an Internet-based distance-learning program in reducing care-resistant behaviors, including agitation, aggression, and irritability, in people with Alzheimer's disease or traumatic brain injury (TBI).
Do I Qualify To Participate in This Study?
Must have:
- Possible or probable Alzheimer's disease (of all severity stages) or moderate to severe TBI at least 6 months prior to study enrollment
- Family caregiver (unpaid) who provides support or supervision for at least one instrumental activity of daily living for the affected person, with direct contact averaging 5 of every 7 days, and 21 hours weekly
- Caregiver report of agitation/aggression, disinhibition, or irritability on the Neuropsychiatric Inventory that is triggered by resistance to care-related activities, such as bathing, taking medications, or attending healthcare appointments
- Generally healthy and able to walk (assistance devices such as a walker or cane are allowed)
- Vision and hearing sufficient to complete testing procedures (hearing aid allowed)
- Cognitive function and spoken/written English sufficient to complete neuropsychological testing
- May be on stable doses of psychoactive agents for at least 30 days
- Access to high-speed/broadband Internet service through home computer capable of operating conference software
Must NOT have:
- Evidence of other psychiatric/neurological disorders that could be the primary source of cognitive impairment, such as stroke, Parkinson's disease, schizophrenia, bipolar or unipolar depression, and seizure disorder
- Psychotic features, such as delusions or hallucinations, that are not adequately treated or not on stable medical therapy for at least 30 days
- Alcoholism or drug misuse within past 2 years
- Any condition that would make the participant or caregiver unsuitable for the study
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Need Help?
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: University of Alabama at Birmingham
Source: ClinicalTrials.gov ID: NCT03734289