Monetary Cost of Alzheimer's Disease in China

Monetary Cost of Alzheimer's Disease in China: Study Protocol for a Cluster Randomized Observational Study

The purpose of the study is to estimate the Chinese economic burden in patients with Alzheimer's Disease (AD).

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Other: observation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 3098

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Alzhemer's disease and their caregivers.

Description

Inclusion Criteria:

1. New patients who are diagnosed with AD in this investigation or old patients who were diagnosed prior to this investigation were eligible；
2. 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<11. 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.
3. 60-year-old and above, men or women.
4. Normal vision or corrected visual, normal audition or corrected auditory, and cooperate with inspections and treatments.
5. Consent to participate with a signed informed consent by himself/herself or guardians.

Exclusion Criteria:

1. 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).
2. 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.
3. Has a history of alcoholism and drug abuse.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Annual National Total Socioeconomic Cost for All AD Patients in China	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.	one year

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Chinese Medical Doctor Association
• Investigators: Study Chair: Jia Jianping, Doctor, Head of Neurology Department, Capital Medical University

Publications and helpful links

General Publications

• Li F, Chen S, Wei C, Jia J. Monetary costs of Alzheimer's disease in China: protocol for a cluster-randomised observational study. BMC Neurol. 2017 Jan 25;17(1):15. doi: 10.1186/s12883-017-0802-9.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: MAC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED