Dataset Information

Monetary costs of Alzheimer's disease in China: protocol for a cluster-randomised observational study.

ABSTRACT: Alzheimer's disease (AD) is the most common type of dementia. International multilateral cost-of-illness (COI) studies have revealed that the cost of treating this disease is huge, which places a significant burden on patients' families and their healthcare systems. However, no such studies have been conducted in China. This study estimates the monetary costs of patients with AD in mainland China.This study planned to start in October 2015 and to finish in March 2016. It covered 30 provincial, municipal, and autonomous regions in mainland China. The sites and research centres in each region were selected randomly. The participating sites include Tier 3 hospitals, psychiatric hospitals, geriatric hospitals, nursing homes, and residences. More than 2500 patients with AD and their caregivers from all of the 81 research centres will be enrolled to fulfil the calculated sample size. The monetary costs of AD, which include direct medical costs, direct non-medical costs, and indirect costs, are being collected using the electronic medical record system and residence health system at each site; face-to-face interviews are being performed when necessary. Descriptive statistics will be used to summarise the patient characteristics and generalised linear models will be developed to calculate the costs.The main findings will include national and per patient annual monetary costs of AD in China.To the best of our knowledge, this is the first large-scale cluster-randomized observational study to estimate the economic burden of AD in Chinese patients. The methodology used was based on China's current healthcare system and is suitable for the purpose of the study. Because the burden of AD on patients, families, healthcare providers, and society is substantial and increasing, it is important and necessary to understand the economic burden caused by this disease.Our trial was retrospectively registered on ClinicalTrials.gov, NCT02694445 , registered on 02/26/2016.

SUBMITTER: Li F

PROVIDER: S-EPMC5264294 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Monetary costs of Alzheimer's disease in China: protocol for a cluster-randomised observational study.

Li Fangyu F Chen Shuoqi S Wei Cuibai C Jia Jianping J

BMC neurology 20170125 1

<h4>Background</h4>Alzheimer's disease (AD) is the most common type of dementia. International multilateral cost-of-illness (COI) studies have revealed that the cost of treating this disease is huge, which places a significant burden on patients' families and their healthcare systems. However, no such studies have been conducted in China. This study estimates the monetary costs of patients with AD in mainland China.<h4>Methods</h4>This study planned to start in October 2015 and to finish in Marc ...[more]

PMID: 28122529

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Project description:IntroductionRecent failures of potential novel therapeutics for Alzheimer's disease (AD) have prompted a drive towards clinical studies in prodromal or preclinical states. However, carrying out clinical trials in early disease stages is extremely challenging-a key reason being the unfeasibility of using classical outcome measures of dementia trials (eg, conversion to dementia) and the lack of validated surrogate measures so early in the disease process. The Deep and Frequent Phenotyping (DFP) study aims to resolve this issue by identifying a set of markers acting as indicators of disease progression in the prodromal phase of disease that could be used as indicative outcome measures in proof-of-concept trials.Methods and analysisThe DFP study is a repeated measures observational study where participants will be recruited through existing parent cohorts, research interested lists/databases, advertisements and memory clinics. Repeated measures of both established (cognition, positron emission tomography (PET) imaging or cerebrospinal fluid (CSF) markers of pathology, structural MRI markers of neurodegeneration) and experimental modalities (functional MRI, magnetoencephalography and/or electroencephalography, gait measurement, ophthalmological and continuous smartphone-based cognitive and other assessments together with experimental CSF, blood, tear and saliva biomarkers) will be performed. We will be recruiting male and female participants aged >60 years with prodromal AD, defined as absence of dementia but with evidence of cognitive impairment together with AD pathology as assessed using PET imaging or CSF biomarkers. Control participants without evidence of AD pathology will be included at a 1:4 ratio.Ethics and disseminationThe study gained favourable ethical opinion from the South Central-Oxford B NHS Research Ethics Committee (REC reference 17/SC/0315; approved on 18 August 2017; amendment 13 February 2018). Data will be shared with the scientific community no more than 1 year following completion of study and data assembly.

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Project description:IntroductionUp to 80% of patients with respiratory tract infections (RTI) attending healthcare facilities in rural areas of China are prescribed antibiotics, many of which are unnecessary. Since 2009, China has implemented several policies to try to reduce inappropriate antibiotic use; however, antibiotic prescribing remains high in rural health facilities.Methods and analysisA cluster randomised controlled trial will be carried out to estimate the effectiveness and cost effectiveness of a complex intervention in reducing antibiotic prescribing at township health centres in Anhui Province, China. 40 Township health centres will be randomised at a 1:1 ratio to the intervention or usual care arms. In the intervention group, practitioners will receive an intervention comprising: (1) training to support appropriate antibiotic prescribing for RTI, (2) a computer-based treatment decision support system, (3) virtual peer support, (4) a leaflet for patients and (5) a letter of commitment to optimise antibiotic use to display in their clinic. The primary outcome is the percentage of antibiotics (intravenous and oral) prescribed for RTI patients. Secondary outcomes include patient symptom severity and duration, recovery status, satisfaction, antibiotic consumption. A full economic evaluation will be conducted within the trial period. Costs and savings for both clinics and patients will be considered and quality of life will be measured by EuroQoL (EQ-5D-5L). A qualitative process evaluation will explore practitioner and patient views and experiences of trial processes, intervention fidelity and acceptability, and barriers and facilitators to implementation.Ethics and disseminationEthical approval was obtained from the Biomedical Research Ethics Committee of Anhui Medical University (Ref: 20180259); the study has undergone due diligence checks and is registered at the University of Bristol (Ref: 2020-3137). Research findings will be disseminated to stakeholders through conferences and peer-reviewed journals in China, the UK and internationally.Trial registration numberISRCTN30652037.

Project description:IntroductionDiabetes management in primary care remains suboptimal in China, despite its inclusion in the essential public health service (EPHS). We aimed to evaluate the effectiveness of a mobile health (mHealth) based and three-tiered diabetes management system in diverse Chinese contexts.Methods and analysisThis is a cluster randomised controlled trial, named road to hierarchical diabetes management at primary care (ROADMAP). 19 008 patients with type 2 diabetes (T2D) were recruited from primary care clinics in 864 communities across 144 counties/districts of 24 provinces. Eligible participants were adult patients diagnosed with T2D and registered for diabetes management in communities. Patients within the same communities (clusters) were randomly allocated into the intervention or control arm for 1 year in a 2:1 ratio. The control arm patients received usual care as EPHS packaged: at least four blood glucose (BG) and blood pressure (BP) tests, and lifestyle and medication instruction, yearly, from primary care providers. The intervention arm patients received at least two BG and one BP tests, monthly, and lifestyle and treatment instruction from a three-tiered contracted team. A mHealth platform, Graded ROADMAP, enabled test results uploading and sharing, and patient referral within the team. The intervention participants will be further divided into basic or intensive intervention group according to whether they were actively using the Your Doctor App. The primary outcome is the BG control rate with glycated haemoglobin (HbA1c)<7.0%. Secondary outcomes include control rates and changes of ABC (HbA1c, BP and low-density lipoprotein cholesterol) and fasting BG, hypoglycaemia episodes and health-related quality of life (EuroQol (EQ-5D)).Ethics and disseminationThe trial has been approved by the Institutional Review Board at Shanghai Sixth People's Hospital. Findings on the intervention effectiveness will be disseminated through peer-reviewed journals, conference presentations and other relevant mechanisms.Trial registration numberChiCTR-IOC-17011325.

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Project description:IntroductionStroke is the leading cause of death and disability in China. The median time of stroke pre-hospital delay is more than 15 hours, mainly due to the lack of awareness on stroke symptoms and calling emergency services. We developed Stroke 1-2-0 recognition tool in China, by adapting Face, Arm, Speech and Time. Our preliminary findings suggested that Stroke 1-2-0 can improve public's knowledge of the stroke symptoms, but its impact on the prehospital delay is still unclear. Furthermore, these findings were mainly obtained from Shanghai, one of the largest metropolises in China. However, more than half of population in China lives in the rural area. Given the striking disparities in socioeconomic status and quality of stroke care across the nation, a multicentre trial is warranted.Methods and analysisStroke 1-2-0 education programme will adopt a multicentre, cluster-randomised controlled design. We aimed to recruit 32 communities from 16 counties across China. Each county includes two communities having more than 100 000 residents. The two communities sampled in the same county will be randomly assigned to receive either Stroke 1-2-0 education programme or usual care. The primary objective of this study is to evaluate the impact of Stroke 1-2-0 public education programme in reducing stroke prehospital delay among adults residing in the community, compared with the usual care. The intervention will be implemented for 1 year. The primary outcomes are the symptom onset to hospital arrival time ('onset-to-door time', ODT) and 3-hour hospital arriving rate. We will use an intention-to-treat approach. A linear mixed model will be used to control for potential cluster effects.Ethics and disseminationThis study is approved by the Shanghai Minhang District Central Hospital Institutional Review Board (Shanghai, China). The findings will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberChiCTR2000040782.

Dataset Information

Monetary costs of Alzheimer's disease in China: protocol for a cluster-randomised observational study.

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Monetary costs of Alzheimer's disease in China: protocol for a cluster-randomised observational study.

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