NCT03397667

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

4.8 years

First QC Date

August 8, 2017

Last Update Submit

December 24, 2025

Conditions

Alzheimer DiseaseVeteransFamily CaregiversCaregiver BurdenQuality of LifeTraumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change from baseline Veterans Quality of Life at 12 months

    Baseline to 12 months

  • Change from baseline Caregiver Burden at 12 months

    Baseline to 12 months

  • Change from baseline Veteran depression at 12 months

    Baseline to 12 months

  • Change from baseline Caregiver depression at 12 months

    Baseline to12 months

  • Change from baseline Veteran anxiety at 12 months

    Baseline to 12 months

  • +2 more secondary outcomes

Study Arms (2)

Control

OTHER

Primary Care

Other: Control

Intervention

EXPERIMENTAL

Primary Care plus ABC ANSWERS intervention

Other: ABC ANSWERS

Interventions

ABC ANSWERSOTHER

Primary Care plus ABC ANSWERS

Intervention
ControlOTHER

Primary Care as usual

Control

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richard L. Roudebush VAMC

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 32306982DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticAlzheimer DiseaseCaregiver Burden

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesDementiaTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor is blinded to which arm a dyad is enrolled.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist, Indiana University Center for Aging Research

Study Record Dates

First Submitted

August 8, 2017

First Posted

January 12, 2018

Study Start

August 1, 2018

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)