Indiana University Dementia Screening Trial: The IU CHOICE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,005
- 试验地点
- 6
- 主要终点
- Health Related Quality of Life (HRQOL)
研究概览
简要总结
The purpose of the study is to conduct a randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 older adults, cared for in typical, primary care practices.
详细描述
The objective of this proposal is to address the question of whether the benefits outweigh the harms of routine screening for dementia among older adults in primary care when the screening program is coupled with primary care practices prepared to provide care for those who screen positive.
The specific aim of the study is to conduct a pragmatic randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 typical, older adults, cared for in typical, primary care practices, prepared to deliver best practices dementia care.
Primary Specific Aim 1:
Test the impact of dementia screening on health-related quality of life of the patient at 12 months.
Primary Specific Aim 2:
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
- Single (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
- •adults age 65 and older;
- •at least one office visit to their primary care physician within the previous year;
- •no previous diagnosis of dementia or memory problem as determined by ICD-9 codes or the presence of prescription for anti-dementia medications (cholinesterase inhibitors or memantine);
- •ability to consent to participate in the study; and
- •ability to communicate in English
排除标准
- •adults who are a permanent resident of a nursing facility;
- •a serious mental illness such as bipolar disorder or schizophrenia as determined by the presence of related ICD-9 codes indicative of such an illness; or
- •a pre-existing diagnosis of dementia or cognitive impairment
研究组 & 干预措施
No Screening
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
Screening Group
Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.
干预措施: Collaborative Dementia Care Program (Behavioral)
结局指标
主要结局
Health Related Quality of Life (HRQOL)
时间窗: 1 month, 6 months, 12 months
The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health.
Patient Health Questionnaire (PHQ-9)
时间窗: 1 month, 6 months, 12 months
The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression. A higher score is associated with more severe depression.
Generalized Anxiety Disorder Scale (GAD-7)
时间窗: 1 month, 6 months, 12 months
The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder. A higher score is associated with more severe anxiety.
次要结局
- Number of Participants With Health Care Utilization(12 months)
- Number of Participants With an Advance Directive at 12 Months(12 months)
研究者
Nicole R. Fowler, PhD
Regenstrief Institute, IU Center for Aging Research Scientist
Regenstrief Institute, Inc.