New training helps families handle tough behaviors in dementia and brain injury
NCT ID NCT03734289
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a distance-learning program for family caregivers of people with Alzheimer's dementia or traumatic brain injury. The goal was to reduce care-resistant behaviors like agitation and aggression, and improve quality of life for both patients and families. 88 caregivers participated, learning strategies to manage challenging behaviors and reduce their own stress.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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88 people
The number who actually took part.
- Started
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Feb 2017
- Finished
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Aug 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
50 participants with possible or probable Alzheimer's disease dementia (of all severity stages) as defined by the NIA-Alzheimer's Association 2011 criteria will be enrolled, along with a family (i.e., unpaid) caregiver. A second cohort of 25 participants who have sustained moderate to severe TBI as diagnosed by UAB-TBIMS standards (generally Glasgow Coma Scale score of 12 or less at admission, cranial imaging with evidence of acute intracranial trauma, and/or post-traumatic amnesia duration of greater than 24 hours) ≥6 months prior to study entry (and their caregivers) will be enrolled. Entry is dependent on caregiver ratings on at least one of three behavioral domains of the Neuropsychiatric Inventory (NPI): 1) Agitation/Aggression, 2) Disinhibition, 3) Irritability /Lability. Based on standard scoring of the NPI, the caregiver must report all of these for at least one domain: * Frequency of "Often" (several times per week but less than every day) or more, * Severity of "Moderate" (stressful and upsetting; may require specific management) or higher * Distress of "Moderate" (fairly distressing, not always easy to cope with) or higher The caregiver must also report that the adverse behavior is triggered by resistance to care-related activities, e.g., bathing, taking medications, attending health-care appointments, etc. Additional inclusion criteria. * Age ranges AD: ≥ 50 years; TBI ≥ 19; Caregiver ≥18 * Sex distribution: both men and women. * Race: any. * Health: generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane). Vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures, or participants who per clinician criteria are deemed eligible to participate in the study. . * Cognitive function and spoken/written English language skills sufficient to provide valid results on neuropsychological testing, or participants who per clinician criteria are deemed eligible to participate in the study. * Concomitant medications: Subjects may be on stable doses of any psycho-active agents for ≥30 days prior to screening and randomization. * Caregiver: unpaid person who provides support or supervision for at least 1 instrumental activity of daily living for the affected person, with direct contact averaging ≥5 of every 7 days, and ≥21 hours weekly. * Access to high-speed/broad band internet service through home computer capable of operating "Go-to-Meeting" or equivalent conferencing software. Exclusion criteria. * Absence of a reliable caregiver who is willing to participate and comply with protocol responsibilities (described below). * Evidence of other psychiatric/neurologic disorders sufficient to be the primary source of cognitive impairment (i.e., stroke, idiopathic Parkinson's disease, schizophrenia, bipolar or unipolar depression, seizure disorder). * Psychotic features (delusions or hallucinations) not adequately treated or not on stable medical therapy for these conditions 30 days prior to enrollment. * Current or recent (within the past 2 years) history of alcoholism or drug misuse. * Subject and/or caregivers who are unwilling or unable to fulfill the requirements of the study. * Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
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Other studies related to the condition(s) this trial covers.
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