Neurologic Signs and SymptomsNCT04022564
Incidence, and Survival Medical Expenditure of Patients With Multiple Sclerosis
An observational study of Neurologic Signs and Symptoms, run by Chun-Ming Liao at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurologic Signs and Symptoms
- How many people
- 2,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2019to 20 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- The subjects are diagnosed as MS patients
Who cannot join
- The subjects are not diagnosed as MS patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Neurologic Signs and Symptoms
- Keywords
- multiple sclerosis, Survival Analysis, cause of death, medical resources
- Medical subject headings
- Neurologic Manifestations, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The subjects are diagnosed as MS patient | 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'. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 'National Health Insurance Research Database' (NHIRD) from 2001 to 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start15 Jul 2019
- Primary completion20 May 2020 (estimated)
- Study completion20 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic Signs and SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chun-Ming Liao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chun-Ming Liao, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022564
- Sponsor's protocol ID
- CMUH108-REC2-084
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, and Survival Medical Expenditure of Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04022564
- Acronym / sponsor ID
- CMUH108-REC2-084
- Conditions
- Neurologic Signs and Symptoms
- Keywords
- multiple sclerosis, Survival Analysis, cause of death, medical resources
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chun-Ming LiaoUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 20 May 2020 (estimated)
- Study completion
- 20 May 2020 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The subjects are diagnosed as MS patient | – | –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'. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- The subjects are diagnosed as MS patients
Key exclusion criteria (1 listed)
- The subjects are not diagnosed as MS patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence, and SurvivalMedical Expenditure of Patients with Multiple Sclerosis
Time frame: 'National Health Insurance Research Database' (NHIRD) from 2001 to 2015
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Signs and Symptoms, run by Chun-Ming Liao at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, and SurvivalMedical Expenditure of Patients with Multiple Sclerosis (time frame: 'National Health Insurance Research Database' (NHIRD) from 2001 to 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.