Clinical trial NCT02051205: Parkinson's Disease Registry
Official title: Parkinson's Disease Registry（PDR）
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Parkinson's disease, risk factors, epidemiology
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in community hospitals or medical centers

Brief summary: The purpose of the Parkinson's disease Registry (PDR) is to develop a nation-wide database of persons with Parkinson's disease (PD) in Taiwan.

Detailed description: Among degenerative neurological disease, PD is the second most common disorder. Although a wide range of incidence and prevalence rate exist in reviewed literatures due to a consequence of variation in study methodologies, the crude prevalence rate above 60 year-old is 1%. Increase in aging population will lead to an increase in PD patients. The PDR will be used to facilitate the understanding of basic epidemiological features of the disease, genetic and non-genetic risk factors, co-morbidity, the up-to-date treatment strategies and the related economic burden from medical and surgical treatment (deep brain stimulation), to develop new therapeutic protocols as well as healthcare policies, and ultimately, to improve the quality of life of PD patients. PDR will also be served as data bank for investigators in the field of PD to quickly identify and notify research subjects about other research studies for which they are eligible. Patient who registered can also sign their consent for a future brain donation after they passed away.

Methods:

The 4 main Tzu Chi Hospitals from Hualien, Da Lin, Taichung, and Taipei will serve as representative of pilot study for National registry. This will be a record-based, multi-center, nation-wide, cohort study. A user-friendly, yet, encrypted registration platform will be provided through internet for authorized personnel. The contents of PDR will be as follow: demographic features, risk factors, clinical profiles of diagnostic criteria, co-morbidity, images profiles, treatment regimens in details, prognosis, health-related quality of life, and neuropsychological assessment batteries.

Expected results:

1. To facilitate the understanding of demographic epidemiological features of PD.
2. To find the risk factors of PD and the possible intervention toward disease prevention in Taiwan.
3. To find the comorbidity of the disease, and the solution toward better treatment and related outcome.
4. Assess current treatment approaches and develop best-practice guidelines.
5. Tracking the health-related quality of life of PD patient as well as care-givers and the economic impact from different treatment regimens of best medications versus surgical interventions (neuromodulation / neuro-regeneration) from time to time.
6. Drive the development of innovative research projects.
7. Accelerate the process of informing patients of research projects for which they may be eligible.

Key words: Parkinson's disease, Registry, Epidemiology, Treatment, Prognosis

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease

Exclusion Criteria:

* None

Primary outcomes:
measure: Risk factors
timeFrame: 1 year
Secondary outcomes:
measure: Motor function
timeFrame: 1 year
Other outcomes:
measure: Cognitive function
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
measure: Depression
timeFrame: 1 year
measure: Comorbidity
timeFrame: 1 year
measure: Cost of medical treatment
timeFrame: 1 year
measure: Initial PD symptoms
timeFrame: 1 year
Locations:
city: Hualien
country: Taiwan
facility: Hualien Tzu Chi Hospital
Study officials:
affiliation: Department of Neurosurgery, Hualien Tzu Chi Hospital
name: Shin-Yuan Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: