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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04022564
Other study ID # CMUH108-REC2-084
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 15, 2019
Est. completion date May 20, 2020

Study information

Verified date July 2019
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multiple sclerosis (MS) is a disease of autoimmune system which attacks the central nervous system and that is one of the most common inflammatory diseases and has caused a heavy disease burden on patients. In the world, the prevalence of MS is on the rise, and the annual growth rate of MS patients in Taiwan is much higher than the whole world (3.78 times). However, it has no discussion or study in references at present, and it is worthwhile to research. MS is not a fatal disease, but its complications make the mortality of its patients three times higher than that of general population. This study will explore the survival and the causes of death for MS patients in Taiwan by cohort study of fourteen years. In addition, in the recent years, the MS patients in Taiwan and the medical resource consumption has increased largely, and it is necessary to conduct the research.


Description:

The study population is based on the 'National Health Insurance Research Database' (NHIRD) from 2001 to 2015 provided by Taiwan Ministry of Health and Welfare. The subjects are diagnosed as MS patients based on the 'Registry for Catastrophic Illness'. First, the investigators will perform the statistical analysis of the incidence, the prevalence, the mortality and the trend analysis of the MS patients diagnosed each year. First, Kaplan-Meier method will be employed to examine the survival curves. Next, Cox proportional hazards model will be used to analyze the survival and related factors. Last, multiple regression analysis will be then performed to analyze the influence of independent variables on patients' medical utilization in each year.

In response to the lack of data on population-based epidemiological studies on MS diseases in Asia, this research wishes to fill the gaps in the studies of global prevention and analyze the patient's survival, mortality risk factors and the medical utilization as a reference for national health policies.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2000
Est. completion date May 20, 2020
Est. primary completion date May 20, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- The subjects are diagnosed as MS patients

Exclusion Criteria:

- The subjects are not diagnosed as MS patients

Study Design


Locations

Country Name City State
Taiwan Genetic and Rare Disease Center Taichung

Sponsors (1)

Lead Sponsor Collaborator
Chun-Ming Liao

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence, and SurvivalMedical Expenditure of Patients with Multiple Sclerosis we will perform the statistical analysis of the incidence, the prevalence, the mortality and the trend analysis of the MS patients diagnosed each year. First, Kaplan-Meier method will be employed to examine the survival curves. Next, Cox proportional hazards model will be used to analyze the survival and related factors. Last, multiple regression analysis will be then performed to analyze the influence of independent variables on patients' medical utilization in each year. 'National Health Insurance Research Database' (NHIRD) from 2001 to 2015