Informal Caregivers ANSWERS-VA

Background: Stroke and traumatic brain injury (TBI) are leading causes of long-term
disability among Veterans and result in the need for care from informal caregivers in the
home setting. There are very few evidence-based, easy-to-deliver follow-up programs to train
Veterans and caregivers across multiple domains post injury. The "Acquiring New Skills While
Enhancing Remaining Strengths for Veterans (ANSWERS-VA)" intervention aims to provide the
Veteran and caregiver dyad with a set of practical skills that each can use in coping with
and managing symptoms of a brain injury, applying a strength-based approach.

Objectives: The objectives of this study are to conduct a randomized controlled trial (RCT)
to evaluate (a) the efficacy of the ANSWERS-VA dyadic intervention with Veterans who have
sustained a stroke and/or TBI and their informal caregivers, and (b) estimate effect sizes
for the ANSWERS-VA intervention. The ANSWERS-VA intervention will be compared with an
educational intervention that will serve as an attention control group.

Specific Aim 1: To tailor the implementation of the ANSWERS-VA intervention to dyads of
Veterans post stroke and/or TBI and their informal caregivers (n=10) and modify the
implementation processes for the RCT.

Specific Aim 2: To test the short-term (immediately post-intervention) and long-term,
sustained (12 and 24 weeks, and at 1 year) efficacy of the ANSWERS-VA intervention for
improving: (a) the primary outcomes of the caregivers' quality of life and unhealthy days,
and (b) the caregiver mediators of task difficulty, threat appraisal, self-efficacy for
caregiving, and optimism.

Specific Aim 3: To evaluate program delivery costs for the ANSWERS-VA intervention and the
educational attention control procedures, and to assess the cost-effectiveness of the
ANSWERS-VA intervention in terms of noncaregiving hours and unhealthy days in caregivers of
Veterans post stroke and/or TBI.

Exploratory Aim 1: To estimate the effect sizes for the ANSWERS-VA intervention for the
caregiver and Veteran on the secondary outcomes of depressive symptoms, social participation,
and quality of the dyadic relationship.

Methods: The investigators propose to conduct a RCT to evaluate the ANSWERS-VA intervention
among Veterans with stroke or TBI and their caregivers (dyads). Veterans with stroke (N =
222) or TBI (N = 108) and their informal caregivers, who have received care at the Michael E.
DeBakey VAMC in Houston or the Richard L. Roudebush VAMC in Indianapolis, will be randomized
to the ANSWERS-VA intervention or to an attention control group. Both the intervention and
control procedures involve 8 telephone sessions delivered over 8 weeks, with a booster
session at 12 weeks. Data collections will occur at baseline, 8 weeks (short-term
intervention effect), 12 weeks (after booster), 24 weeks, and 1 year after baseline
(long-term sustainability of intervention effect). Linear mixed models will be applied to the
repeated-measures data to test efficacy of the program in stroke caregivers and to estimate
effect sizes in TBI caregivers. An incremental cost-effectiveness ratio will be employed to
address the comparative costs and outcomes for the ANSWERS-VA intervention and attention
control groups.

Status: Essential modifications for this project were requested and approved via VA Central
Office. IRB approval has been obtained for these modifications in Indianapolis and in
Houston. Graduate students from multiple disciplines have been hired and have received two
days of onsite training specific to the ANSWERS-VA intervention and control procedures,
screening, recruitment, and data collection processes. The REDCap database has been updated
for the project modifications and has been further tested. The investigators are currently
working with frontline providers at both sites to recruit potential participants for this
RCT. Enrollment of first subject dyads began November, 2014. At this time, the investigators
have completed recruitment of new dyads. We continue to complete outcomes assessments on some
dyads. We plan to submit an abstract to the International Stroke Conference in January 2019.

Inclusion Criteria:

- Informal caregiver of a family member or friend (Veteran) with a stroke or TBI

- Caregiver must express need or concerns in providing care

- Plans to be providing care for 1 year or longer

- Access to telephone

- Willingness to participate in 9 call from a nurse and 5 data collection calls at
designated timepoints

- Veteran's stroke must be within past 3 years

- Veteran's TBI must be since 9/11/01

Exclusion Criteria:

- Caregiver or survivor age < 18 years

- Caregiver denies that survivor has had a stroke or a TBI

- Caregiver does not consider him or herself a caregiver, stating that the survivor is
not impaired or is the same as before the stroke or TBI

- Caregiver has low task difficulty (OCBS task difficulty score < 16)

- Caregiver communication difficulties (e.g., hearing loss)

- Caregiver not fluent in the English language

- Caregiver with serious medical illness limiting ability to participate

- Caregiver refuses to sign a HIPAA authorization allowing the VA to store personal
health information (PHI) in a location outside the VA

- Survivor residing in a nursing home or long-term care facility

- Survivor or caregiver has a terminal illness (e.g., cancer, end of life condition with
decreased life expectancy, renal failure requiring dialysis)

- Survivor or caregiver history of hospitalization for alcohol or drug abuse

- Survivor or caregiver history of Alzheimer's, dementia, suicidal tendencies, severe
untreated depression or manic depressive disorder, or schizophrenia.

- Survivor or caregiver pregnancy

- Survivor or caregiver is a prisoner or on house arrest

- Survivor had a Transient Ischemic Attack (rather than a hemorrhagic or ischemic
stroke)

- Survivor had a stroke more than 3 years ago