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Clinical Trials/NCT03734289
NCT03734289
Completed
Not Applicable

Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With Alzheimer Dementia and Traumatic Brain Injury (NeuroNS) Study

University of Alabama at Birmingham1 site in 1 country88 target enrollmentFebruary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
University of Alabama at Birmingham
Enrollment
88
Locations
1
Primary Endpoint
Change in Zarit Burden Interview
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
August 31, 2021
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Geldmacher

Professor

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Zarit Burden Interview

Time Frame: Change from baseline to 6-month follow-up

A measure of caregiver burden

Secondary Outcomes

  • Change in Connor-Davidson Resilience Scale (CD-RISC)(Change from baseline through 6-month follow-up)
  • Change in Family Quality of Life (Dementia or TBI versions)(Change from baseline through 6-month follow-up)
  • Change in Neuropsychiatric Inventory(Change from baseline through 6-month follow-up)
  • Change in Dementia Quality of Life (DEMQOL/DEMQOL proxy)(Change from baseline through 6-month follow-up)

Study Sites (1)

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