The Aging Brain ANSWERS Program: Veterans Living With Alzheimer's and Traumatic Brain Injury and Caregiver Burden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Change from baseline Caregivers Quality of Life at 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor is blinded to which arm a dyad is enrolled.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
Primary Care
干预措施: Control (Other)
Intervention
Primary Care plus ABC ANSWERS intervention
干预措施: ABC ANSWERS (Other)
结局指标
主要结局
Change from baseline Caregivers Quality of Life at 12 months
时间窗: 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.
次要结局
- Change from baseline Veteran depression at 12 months(Baseline to 12 months)
- Change from baseline Caregiver Burden at 12 months(Baseline to 12 months)
- Change from baseline Veteran anxiety at 12 months(Baseline to 12 months)
- Change from baseline Caregiver depression at 12 months(Baseline to12 months)
- Change from Caregiver anxiety at 12 months(Baseline to 12 months)
- Change from Caregiver dyadic strain at 12 months(Baseline to 12 months)
- Change from baseline Veterans Quality of Life at 12 months(Baseline to 12 months)
研究者
Nicole R. Fowler, PhD
Scientist, Indiana University Center for Aging Research
Indiana University