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Published in: Trials 1/2020

01-12-2020 | Central Nervous System Trauma | Study protocol

Supporting caregivers of veterans with Alzheimer’s disease and traumatic brain injury: study protocol for a randomized controlled trial

Authors: Jennifer L. Carnahan, Katherine S. Judge, Joanne K. Daggy, James E. Slaven, Nicki Coleman, Emily L. Fortier, Christopher Suelzer, Nicole R. Fowler

Published in: Trials | Issue 1/2020

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Abstract

Background

Patients with Alzheimer’s disease and related dementias (ADRD) and traumatic brain injury (TBI) and their caregivers require cognitive and behavioral symptom management, interdisciplinary care, support for caregivers, and seamless care coordination between providers. Caring for someone with ADRD or TBI is associated with higher rates of psychological morbidity and burden, social isolation, financial hardship, and deterioration of physical health. Tremendous need exists for primary care–based interventions that concurrently address the care needs of dyads and aim to improve care and outcomes for both individuals with ADRD and TBI and their family caregivers.

Methods

The Aging Brain Care Acquiring New Skills While Enhancing Remaining Strengths (ABC ANSWERS) study is a randomized controlled trial that tests the effectiveness of an intervention based on two evidence-based programs that have been developed for and previously tested in populations with ADRD, TBI, stroke, and late-life depression and/or who have survived an intensive care unit stay. This study includes 200 dyads comprised of a veteran with a diagnosis of ADRD or TBI and the veteran’s primary informal caregiver. Dyads are randomized to receive the ABC ANSWERS intervention or routine Veterans Health Administration (VHA) primary care with a standardized educational and resource information packet. Data collection occurs at baseline and three follow-up time points (3 months, 6 months, and 12 months). The primary outcome is caregiver quality of life (QoL). A secondary measure for the caregiver is caregiver burden. Secondary measures for both the veteran and caregiver include symptoms of depression and anxiety.

Discussion

The ABC ANSWERS intervention integrates common features of an evidence-based collaborative care model for brain health while concurrently attending to the implementation barriers of delivering care and skills to dyads. We hypothesize that caregivers in dyads randomized to the ABC ANSWERS program will experience higher levels of QoL and lower levels of depression, anxiety, dyadic strain, and caregiver burden at 12 months than those receiving usual VHA primary care.

Trial registration

ClinicalTrials.gov, NCT03397667. Registered on 12 January 2018.
Appendix
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Metadata
Title
Supporting caregivers of veterans with Alzheimer’s disease and traumatic brain injury: study protocol for a randomized controlled trial
Authors
Jennifer L. Carnahan
Katherine S. Judge
Joanne K. Daggy
James E. Slaven
Nicki Coleman
Emily L. Fortier
Christopher Suelzer
Nicole R. Fowler
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4199-1

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