The Aging Brain ANSWERS Program

Quality of Life Clinical Trial

— ABC ANSWERS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397667
• Other study ID #: #1706902669
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain Injuries
• Brain Injuries, Traumatic
• Caregiver Burden
• Family Caregivers
• Quality of Life
• Traumatic Brain Injury
• Veterans

Intervention

Other:
• ABC ANSWERS
Primary Care plus ABC ANSWERS
• Control
Primary Care as usual

Locations

Country	Name	City	State
United States	Richard L. Roudebush VAMC	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Cleveland State University, Richard L. Roudebush VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 12 months
Secondary	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.	Baseline to 12 months
Secondary	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.	Baseline to 12 months
Secondary	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.	Baseline to 12 months
Secondary	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.	Baseline to12 months
Secondary	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.	Baseline to 12 months
Secondary	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.	Baseline to 12 months
Secondary	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.	Baseline to 12 months