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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-16-1-0527 | Other Grant/Funding Number | US Dept of Defense | |
| CDMRP-AZ150084 | Other Grant/Funding Number | Congressionally Directed Medical Research Programs |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Congressionally Directed Medical Research Programs | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Coaching | Active Comparator | Immediately following randomization, online coaching sessions will occur weekly for 6 weeks. Web-based courses containing instructional materials that deal with preventing and reducing care resistant behavior (CRB) within intimate care (dressing, bathing, toileting) and treatment regimens (medication, therapeutic activities) after the initial study visit. The NeuroNS-Care intervention is an innovative distance-learning , internet based, family caregiver coaching program; one for the caregivers of persons with dementia and one for the caregivers of persons recovering from TBI. It will be delivered using Instructure's Canvasâ„¢ web-based platform. |
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| Delayed Coaching | Active Comparator | 6 weeks following the initial visit, online coaching sessions will occur weekly for 6 weeks. Web-based courses containing instructional materials that deal with preventing and reducing care resistant behavior (CRB) within intimate care (dressing, bathing, toileting) and treatment regimens (medication, therapeutic activities) after the initial study visit. The NeuroNS-Care intervention is an innovative distance-learning , internet based, family caregiver coaching program; one for the caregivers of persons with dementia and one for the caregivers of persons recovering from TBI. It will be delivered using Instructure's Canvasâ„¢ web-based platform. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caregiver Coaching | Behavioral | Online coaching sessions will occur weekly for 6 weeks. Web-based courses containing instructional materials that deal with preventing and reducing care resistant behavior (CRB) within intimate care (dressing, bathing, toileting) and treatment regimens (medication, therapeutic activities) after the initial study visit. The NeuroNS-Care intervention is an innovative distance-learning , internet based, family caregiver coaching program; one for the caregivers of persons with dementia and one for the caregivers of persons recovering from TBI. It will be delivered using Instructure's Canvasâ„¢ web-based platform. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Zarit Burden Interview | A measure of caregiver burden | Change from baseline to 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dementia Quality of Life (DEMQOL/DEMQOL proxy) | Measures of quality of life for the person with dementia | Change from baseline through 6-month follow-up |
| Change in Neuropsychiatric Inventory |
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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:
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.
Exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| David Geldmacher, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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Caregivers will be randomized in a 1:1 ratio for immediate intervention vs. a 6 week delayed intervention
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Measure of behavioral symptomsand caregiver distress
| Change from baseline through 6-month follow-up |
| Change in Family Quality of Life (Dementia or TBI versions) | Measures of family function and family-based quality of life | Change from baseline through 6-month follow-up |
| Change in Connor-Davidson Resilience Scale (CD-RISC) | Measure of caregiver resilience | Change from baseline through 6-month follow-up |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |