Caregiver Outcomes of Alzheimer's Disease Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,822
- 试验地点
- 4
- 主要终点
- Short Form Health Survey (SF-36)
研究概览
简要总结
This study will measure the risks and benefits of early screening of Alzheimer's disease. Early diagnosis through screening may enhance the family member's transition to a family caregiver and reduce caregiver burden by providing an opportunity for the family member to learn about the syndrome, receive interventions, and to prepare for their new care giving role.
详细描述
We are proposing the first randomized controlled trial (RCT) to evaluate the benefits and harms of AD screening on family members of older adults. The proposed trial will randomize 1,800 dyads (older adult and family member) into three groups. Older adults in the first group will be screened for AD at baseline coupled with disclosure of the screening results to the dyad and to the patient's primary care provider (Screening Only Group). Older adults in the second group will be screened for AD at baseline coupled with disclosure of the screening results and, if they screen positive, referred to the Aging Brain Care (ABC) Program for diagnostic evaluation and care, if AD is diagnosed (Screening Plus Group). Older adults in the third group will not be screened at baseline and will observed through surveillance of the patients' EHR for any screening or incident AD diagnoses that occurs as part of routine care. At the last follow-up assessment (24 months) we will we will screen the older adults and conduct an interview with the family caregiver to detect possible cognitive impairment (Control Group).
Specific Aim 1: Evaluate the impact of AD screening on family members' quality of life.
Hypothesis 1: In comparison to the control group, family members randomized to the screening only or the screening plus groups will express higher levels of health-related quality of life at 24 months as measured by the Short Form Health Survey (SF-36).
Specific Aim 2: Evaluate the impact of AD screening on family members' mood and anxiety.
Hypothesis 2: In comparison to the control group, family members randomized to the screening only or the screening plus groups will express lower rates of depressive and anxiety symptoms at 24 months as measured by the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder Scale (GAD-7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years or older
- •At least one visit to primary care practice within past 24 months
- •Ability to provide informed consent
- •Ability to communicate in English
- •Family Members
- •21 years or older
- •Identified by the patient as the person most likely to provide them care if needed.*
- •Lives with the patient or lives within a 50 mile radius.
- •Ability to provide informed consent.
- •Ability to communicate in English
排除标准
- •Has a diagnosis of AD as determined by ICD-10 code.
- •Evidence of a prescription for a cholinesterase inhibitors or memantine.
- •Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
- •Permanent resident of a nursing facility
- •Already seen by the Healthy Aging Brain Care Program
- •Family Member
- •Is a non-family member who is not a legal Healthcare Power of Attorney
- •Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
- •Has a diagnosis of AD as determined by ICD-10 code.
结局指标
主要结局
Short Form Health Survey (SF-36)
时间窗: 24 month
The SF-36 is a general population instrument that measures health-related quality of life, mental, physical, and social functioning. It includes one multi-item scale that assesses 8 overall health concepts. These concepts are aggregated into a Physical Component Summary and a Mental Component Summary. The eight domains are combined to reach two summary scores for Physical and Mental Health which are standardized to a mean of 50, with a score above 50 representing better than average and below 50 poorer than average function.
次要结局
- Depressive Symptoms(PHQ-9 results for patient & family member at 24 months)
- Anxiety Symptoms(24 month GAD-7 scores for Family members & Patients)
- Caregiving Preparedness(24 month)
- Caregiving Self Efficacy(24 month result for Family member)
研究者
Nicole R. Fowler, PhD
Scientist, Indiana University Center for Aging Research
Indiana University