Clinical trial NCT03734289: Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With AD and TBI
Official title: Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With Alzheimer Dementia and Traumatic Brain Injury (NeuroNS) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Traumatic Brain Injury
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-11-07
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Caregivers will be randomized in a 1:1 ratio for immediate intervention vs. a 6 week delayed intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: To reduce care resistant behaviors (CRB) among people with dementia residing in nursing homes, to a distance-learning education, training, and coaching program for family caregivers of people with dementia or TBI; assess the efficacy of the intervention for reducing frequency or severity of CRB-triggered symptoms of agitation, aggression, and irritability; assess the efficacy of the intervention for improving quality of life of patients, caregivers, and families; and determine how patient and caregiver characteristics influence the effectiveness of the intervention.

5. Evaluate how the intervention affects the health care costs of people with dementia or TBI.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Zarit Burden Interview
timeFrame: Change from baseline to 6-month follow-up
Secondary outcomes:
measure: Change in Dementia Quality of Life (DEMQOL/DEMQOL proxy)
timeFrame: Change from baseline through 6-month follow-up
measure: Change in Neuropsychiatric Inventory
timeFrame: Change from baseline through 6-month follow-up
measure: Change in Family Quality of Life (Dementia or TBI versions)
timeFrame: Change from baseline through 6-month follow-up
measure: Change in Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Change from baseline through 6-month follow-up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: David Geldmacher, MD
role: PRINCIPAL_INVESTIGATOR
References: