Clinical trial NCT03397667: The Aging Brain ANSWERS Program
Official title: The Aging Brain ANSWERS Program: Veterans Living With Alzheimer's and Traumatic Brain Injury and Caregiver Burden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Alzheimer Disease
Veterans
Family Caregivers
Caregiver Burden
Quality of Life
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Richard L. Roudebush VA Medical Center
name: Cleveland State University
First posted: 2018-01-12
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test the effectiveness of an intervention for Veterans diagnosed with Alzheimer's Disease (AD) or Traumatic Brain Injury (TBI) and the burden on their informal (family/friend) caregiver.

Detailed description: The majority of people with Alzheimer's (AD) and Traumatic brain Injury (TBI) are cared for in primary care settings and receive significant amounts of care and assistance in activities of daily living from family members or friends.

The ABC ANSWERS intervention will incorporate and integrate the common features of an evidence-based collaborative care model for brain care, while also attending to the implementation barriers of delivering care and skills to dyads of patients with AD and TBI and their family caregivers.

The study team will conduct a 1-year randomized control trial (RCT) designed to improve the Quality of Life (QoL) of Veterans with AD and TBI, and their family caregivers, and decrease their family caregivers' burden. The dyads in the intervention group will receive primary care plus ABC ANSWERS. The control group will receive primary care.

Eligibility criteria: Inclusion Criteria:

* Veterans: 1)Diagnosis of AD or TBI 2) Receives Primary Care from Veterans Administration Medical Center (VAMC)
* Caregivers: 1) Primary caregiver (family or friend) of a Veteran with AD or TBI 2) Plans to provide care for 1 year or longer
* Both: 1) Over 18 years of age 2) Speak and understand English 3) access to telephone

Exclusion Criteria:

* Veterans: 1) Resides in nursing home or long term care facility 2) currently receiving care in GRACE clinic 3) Enrolled in ANSWERS-VA research study
* Caregivers: 1) Does not consider him/herself a caregiver for Veteran 2) Serious medical illness limiting ability to participate
* Both: Unable to contact within 10 calls Age \< 18 years Either caregiver or Veteran denies that they have AD or a TBI Either the caregiver or Veteran does not want to participate Not fluent in the English language Difficulty hearing or talking by telephone Has a terminal illness (e.g., cancer, end of life condition with decreased life expectancy, renal failure requiring dialysis) History of hospitalization for alcohol or drug abuse History of severe mental illness (e.g., suicidal tendencies, severe untreated depression or bipolar disorder, or schizophrenia) Prisoner or on house arrest

Primary outcomes:
measure: Change from baseline Caregivers Quality of Life at 12 months
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Change from baseline Veterans Quality of Life at 12 months
timeFrame: Baseline to 12 months
measure: Change from baseline Caregiver Burden at 12 months
timeFrame: Baseline to 12 months
measure: Change from baseline Veteran depression at 12 months
timeFrame: Baseline to 12 months
measure: Change from baseline Caregiver depression at 12 months
timeFrame: Baseline to12 months
measure: Change from baseline Veteran anxiety at 12 months
timeFrame: Baseline to 12 months
measure: Change from Caregiver anxiety at 12 months
timeFrame: Baseline to 12 months
measure: Change from Caregiver dyadic strain at 12 months
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VAMC
state: Indiana
Study officials:
References:
citation: Carnahan JL, Judge KS, Daggy JK, Slaven JE, Coleman N, Fortier EL, Suelzer C, Fowler NR. Supporting caregivers of veterans with Alzheimer's disease and traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2020 Apr 19;21(1):340. doi: 10.1186/s13063-020-4199-1.