Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
236 participants
INTERVENTIONAL
2018-08-01
2023-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Control
Primary Care
Control
Primary Care as usual
Intervention
Primary Care plus ABC ANSWERS intervention
ABC ANSWERS
Primary Care plus ABC ANSWERS
Interventions
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ABC ANSWERS
Primary Care plus ABC ANSWERS
Control
Primary Care as usual
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Richard L. Roudebush VA Medical Center
FED
Cleveland State University
OTHER
Indiana University
OTHER
Responsible Party
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Nicole R. Fowler, PhD
Scientist, Indiana University Center for Aging Research
Locations
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Richard L. Roudebush VAMC
Indianapolis, Indiana, United States
Countries
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References
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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.
Other Identifiers
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AZ160032
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
#1706902669
Identifier Type: -
Identifier Source: org_study_id