Monetary Cost of Alzheimer's Disease in China: Study Protocol for a Cluster Randomized Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,098
- 试验地点
- 1
- 主要终点
- The Annual National Total Socioeconomic Cost for All AD Patients in China
研究概览
简要总结
The purpose of the study is to estimate the Chinese economic burden in patients with Alzheimer's Disease (AD).
详细描述
This observational study covered all the 30 provincials/municipals/autonomous in mainland China except Hong Kong and Macau. Tier 3 hospitals, psychiatric hospitals, elderly hospitals, nursing home and communities were randomly selected as research centers, and more than 2500 patients with AD and their caregivers were enrolled at last. The main outcome of this study was assessed not only by the electronic medical system of communities and hospitals, but also by questionnaires. Using a societal prevalence-based gross COI approach to estimated the total yearly costs of AD in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New patients who are diagnosed with AD in this investigation or old patients who were diagnosed prior to this investigation were eligible；
- •AD diagnosis must meet criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA). The diagnosis should also meet the following: Modified Hachinski Ischemic Scale (MHIS) score≤4, Activity of Daily Living Scale (ADL) score≥23, Geriatric Depression Scale (GDS) score<
- •Neuroimaging MRI support AD diagnosis (exist atrophy in medial temporal lobe, white matter lesions score≤2 minutes according to the Fazekas criteria. AD disease classification according to mini-mental state examination (MMSE) scale (for illiterate dementia: mild: 21~24 points; moderate: 11~20 points; severe: 10 points or less; for lettered dementia: mild: 16~19 points; moderate: 8~15 points; severe: 7 points or less). The diagnosis of AD was confirmed by brain CT or MRI scans and by laboratory tests to rule out any other significant comorbidity.
- •60-year-old and above, men or women.
- •Normal vision or corrected visual, normal audition or corrected auditory, and cooperate with inspections and treatments.
- •Consent to participate with a signed informed consent by himself/herself or guardians.
排除标准
- •Patient with vascular dementia or dementia caused by other reasons, such as major depression or other major psychiatric illnesses, thyroid dysfunction, encephalitis, multiple sclerosis, and other dementia which includes frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), and Parkinson's dementia (PDD).
- •MRI and laboratory tests (blood cell counts, liver and renal function, electrolyte, vitamin B12/folic, HIV, syphilis, and so on) do not support or rule out AD diagnoses.
- •Has a history of alcoholism and drug abuse.
结局指标
主要结局
The Annual National Total Socioeconomic Cost for All AD Patients in China
时间窗: one year
The annual national total socioeconomic cost for all patients with AD in China in 2015 was obtained, with the average annual cost per patient with AD from our results multiplied by the all number of patients with AD in 2015. So, the value reported in the data table below represents the total cost for all all participants in China.
次要结局
未报告次要终点
研究者
Jianping Jia
Professor
Beijing Friendship Hospital