Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With AD and TBI

To address the previously unanswered question of whether theoretically-driven caregiver
education and coaching in nonpharmacologic approaches to reduce care resistant behaviors as a
trigger of behavioral and psychiatric symptoms of dementia (BPSD) and neuropsychiatric
symptoms after Traumatic Brain Injury (NPTBI) will improve caregiver burden, quality of life
(QOL), and related outcomes of patients with these conditions and their family members. The
intervention of interest is the Neurobehavioral Non-Pharmacologic Supportive Strategies for
Family Caregivers of Persons with Dementia or TBI (NeuroNS-Care). Behavioral symptoms in
dementia and following TBI vary considerably over time, with a tendency toward spontaneous
regression to the mean. Additionally, caregivers often develop idiosyncratic strategies in
response to adverse behaviors that might be either adaptive or maladaptive. In order to
separate the effects of time alone from the effects of the coaching intervention, one group
will be randomized to delayed intervention following a 6 week wait time. This will allow the
investigative team the opportunity to compare the natural history of the outcome variables in
an "untrained" portion of the sample to the effects of training over a similar time period.

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.