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Traumatic Brain InjuryABC ANSWERSNCT03397667

The Aging Brain ANSWERS Program

A study testing ABC ANSWERS in people with Traumatic Brain Injury and Alzheimer Disease, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
ABC ANSWERS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
1 siteUnited States
Study dates
1 Aug 2018to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Richard L. Roudebush VAMC

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: The Aging Brain ANSWERS Program: Veterans Living With Alzheimer's and Traumatic Brain Injury and Caregiver Burden

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.

Read the 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.

Being tested
ABC ANSWERS, Control
Medical subject headings
Brain Injuries, Traumatic, Alzheimer Disease, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABC ANSWERSOther

    Primary Care plus ABC ANSWERS

  • ControlOther

    Primary Care as usual

Study groups in NCT03397667
Study groupRoleWhat they receive
ControlOtherPrimary Care
Receives: Other: Control
InterventionExperimentalPrimary Care plus ABC ANSWERS intervention
Receives: Other: ABC ANSWERS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Caregivers Quality of Life at 12 months

    Measure of quality of life using the 12 item Logsdon's Quality of Life scale. Items are scored on a scale from 0-3, "poor to excellent". The higher the score, the better the reporting of item.

    Measured: Baseline to 12 months

Secondary outcomes (7)

  1. Change from baseline Veterans Quality of Life at 12 months

    Measure of quality of life using the 12 item Logsden's Quality of Life scale. Items are scored on a scale from 0-3, "poor to excellent". The higher the score, the better the reporting of item.

    Measured: Baseline to 12 months

  2. Change from baseline Caregiver Burden at 12 months

    Caregiver burden is measured using the Oberst Caregiver Burden Scale (OCBS). This is a valid 15 item questionnaire that rates 15 different types of caregiving tasks for informal caregivers based on perceived time and difficulty of the task. For each item the caregiver chooses a value from not difficult(0) to extremely difficult (5). Scores are averaged across 15 items of the time and difficulty subscales, thus achieving a score between 1 and 5 for each.

    Measured: Baseline to 12 months

  3. Change from baseline Veteran depression at 12 months

    Measure of Veteran depression using the Center for Epidemilogic Scale -Depression (CESD).This is a twenty item questionnaire comprising of six scales reflecting major facets of depression. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

    Measured: Baseline to 12 months

  4. Change from baseline Caregiver depression at 12 months

    Measure of Caregiver depression using the Center for Epidemilogic Scale -Depression (CESD).This is a twenty item questionnaire comprising of six scales reflecting major facets of depression. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

    Measured: Baseline to12 months

  5. Change from baseline Veteran anxiety at 12 months

    Measure of anxiety using the Generalized Anxiety Disorder Scale (GAD-7). This is a seven item anxiety scale with a total score from 0-21. Items are scored from "Not at all" (0) to "Nearly everyday" (3). The higher the score, the more often anxiety symptoms are endorsed.

    Measured: Baseline to 12 months

  6. Change from Caregiver anxiety at 12 months

    Measure of anxiety using the Generalized Anxiety Disorder Scale (GAD-7). This is a seven item anxiety scale with a total score from 0-21. Items are scored from "Not at all" (0) to "Nearly everyday" (3). The higher the score, the more often anxiety symptoms are endorsed.

    Measured: Baseline to 12 months

  7. Change from Caregiver dyadic strain at 12 months

    This is a 12 item scale ranging from strongly agree (3) to strongly disagree (0). The higher the score the more the respondent agrees or endorses relationship strain.

    Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2018
  2. Study start1 Aug 2018
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03397667
Sponsor's protocol ID
#1706902669
Other IDs
AZ160032
Acronym
ABC ANSWERS
Status last verified
Dec 2025
First submitted
8 Aug 2017
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32306982

Questions about this trial

What is this clinical trial studying?

A study testing ABC ANSWERS in people with Traumatic Brain Injury and Alzheimer Disease, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Caregivers Quality of Life at 12 months (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03397667, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.

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