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Completed

NCT Number: NCT03397667

The Aging Brain ANSWERS Program

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.

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Key information

Conditions

Traumatic Brain Injury Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Brain Injuries Brain Injuries, Traumatic Caregiver Burden Central Nervous System Diseases Craniocerebral Trauma Dementia Family Caregivers Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Quality of Life Stress, Psychological Tauopathies Trauma, Nervous System Veterans Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richard L. Roudebush VAMC

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABC ANSWERS

Other

Primary Care plus ABC ANSWERS

Control

Other

Primary Care as usual

Primary outcomes

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

    Time frame: Baseline to 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.

Secondary outcomes

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

    Time frame: Baseline to 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.

  2. Change from baseline Caregiver Burden at 12 months

    Time frame: Baseline to 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.

  3. Change from baseline Veteran depression at 12 months

    Time frame: Baseline to 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.

  4. Change from baseline Caregiver depression at 12 months

    Time frame: Baseline to12 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.

  5. Change from baseline Veteran anxiety at 12 months

    Time frame: Baseline to 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.

  6. Change from Caregiver anxiety at 12 months

    Time frame: Baseline to 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.

  7. Change from Caregiver dyadic strain at 12 months

    Time frame: Baseline to 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Cleveland State University
  • Richard L. Roudebush VA Medical Center

Registry information

Official study title

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

Acronym: ABC ANSWERS

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2018
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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