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The Aging Brain ANSWERS Program (ABC ANSWERS)

Primary Purpose

Traumatic Brain Injury, Alzheimer Disease, Veterans

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABC ANSWERS
Control
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Richard L. Roudebush VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Intervention

Arm Description

Primary Care

Primary Care plus ABC ANSWERS intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 8, 2017
Last Updated
September 29, 2023
Sponsor
Indiana University
Collaborators
Richard L. Roudebush VA Medical Center, Cleveland State University
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1. Study Identification

Unique Protocol Identification Number
NCT03397667
Brief Title
The Aging Brain ANSWERS Program
Acronym
ABC ANSWERS
Official Title
The Aging Brain ANSWERS Program: Veterans Living With Alzheimer's and Traumatic Brain Injury and Caregiver Burden
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Richard L. Roudebush VA Medical Center, Cleveland State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Alzheimer Disease, Veterans, Family Caregivers, Caregiver Burden, Quality of Life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor is blinded to which arm a dyad is enrolled.
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Primary Care
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Primary Care plus ABC ANSWERS intervention
Intervention Type
Other
Intervention Name(s)
ABC ANSWERS
Intervention Description
Primary Care plus ABC ANSWERS
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Primary Care as usual
Primary Outcome Measure Information:
Title
Change from baseline Caregivers Quality of Life at 12 months
Description
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.
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Change from baseline Veterans Quality of Life at 12 months
Description
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.
Time Frame
Baseline to 12 months
Title
Change from baseline Caregiver Burden at 12 months
Description
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.
Time Frame
Baseline to 12 months
Title
Change from baseline Veteran depression at 12 months
Description
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.
Time Frame
Baseline to 12 months
Title
Change from baseline Caregiver depression at 12 months
Description
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.
Time Frame
Baseline to12 months
Title
Change from baseline Veteran anxiety at 12 months
Description
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.
Time Frame
Baseline to 12 months
Title
Change from Caregiver anxiety at 12 months
Description
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.
Time Frame
Baseline to 12 months
Title
Change from Caregiver dyadic strain at 12 months
Description
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.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Richard L. Roudebush VAMC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32306982
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.
Results Reference
derived

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The Aging Brain ANSWERS Program

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