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The Aging Brain ANSWERS Program (ABC ANSWERS)

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ClinicalTrials.gov Identifier: NCT03397667
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
Richard L. Roudebush VA Medical Center
Cleveland State University
Information provided by (Responsible Party):
Nicole R. Fowler, PhD, Indiana University

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Alzheimer Disease Veterans Family Caregivers Caregiver Burden Quality of Life Other: ABC ANSWERS Other: Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor is blinded to which arm a dyad is enrolled.
Primary Purpose: Health Services Research
Official Title: The Aging Brain ANSWERS Program: Veterans Living With Alzheimer's and Traumatic Brain Injury and Caregiver Burden
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Control
Primary Care
Other: Control
Primary Care as usual

Experimental: Intervention
Primary Care plus ABC ANSWERS intervention
Other: ABC ANSWERS
Primary Care plus ABC ANSWERS




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397667


Contacts
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Contact: Laura Plue 317-988-2351 Laura.Plue@va.gov

Locations
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United States, Indiana
Richard L. Roudebush VAMC Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Laurie Plue, MA    317-988-2351    Laura.Plue@va.gov   
Contact: Sandra Beech    317-988-2258      
Sponsors and Collaborators
Indiana University
Richard L. Roudebush VA Medical Center
Cleveland State University

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Responsible Party: Nicole R. Fowler, PhD, Scientist, Indiana University Center for Aging Research, Indiana University
ClinicalTrials.gov Identifier: NCT03397667     History of Changes
Other Study ID Numbers: #1706902669
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Brain Injuries
Brain Injuries, Traumatic
Dementia
Tauopathies
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries