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The prodromal phase of Parkinson's Disease; Symptoms, duration, health care resource use and costs over a 5-year period prior to the diagnosis is made.

De vroege beginfase van de ziekte van Parkinson; Symptomen, duur, zorgconsumptie en gezondheidszorgkosten in de 5 jaar voorafgaande aan het stellen van de diagnose.



- candidate number7948
- NTR NumberNTR2295
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-apr-2010
- Secondary IDs10-N-30 METC Atrium-Orbis-Zuyd
- Public TitleThe prodromal phase of Parkinson's Disease; Symptoms, duration, health care resource use and costs over a 5-year period prior to the diagnosis is made.

De vroege beginfase van de ziekte van Parkinson; Symptomen, duur, zorgconsumptie en gezondheidszorgkosten in de 5 jaar voorafgaande aan het stellen van de diagnose.
- Scientific TitleThe preclinical phase of idiopathic Parkinson's Disease; A retrospective study to evaluate the motor and non-motor symptoms, duration, health care resource use and costs over a 5-year period prior to th diagnosis is made.
- ACRONYM
- hypothesisIdiopathic Parkinson's Disease is a chronic progressive neurodegenerative disorder. The preclinical phase of the disease is accompanied by different motor and non-motor symptoms and signs. These symptoms can occur even 5-8 years before classical motor symptoms develop and are sometimes very aspecific. Therefore the delay before diagnosis can last months to years. It is expected that this prodromal phase is associated with significant health care resource burden and costs due to outpatient care, inpatient care, drugs, diagnostic investigations and professional home care. Also production loss due to long-term sick-leave and early retirement and informal care give significant burden on families and society. It is expected that the total economic burden of this preclinical phase is high; however, the exact costs are not known. This retrospective study will investigate the symptoms, duration, health care resource use and costs of the preclinical phase in patients with idiopathic Parkinson's Disease over a 5-year period prior to the diagnosis is made. These economic burden shall be compared with age matched control subjects. The aim of this study is to increase knowledge about the impact of this preclinical phase. Further more, health practitioners might be able to make an earlier diagnosis and start the correct therapy as soon as possible.
- Healt Condition(s) or Problem(s) studiedParkinson's disease, Health care costs, Preclinical phase, Health care resource use
- Inclusion criteria1. Idiopathic Parkinson's Disease according to the U.K. Parkinson's Disease Society Brain Bank Criteria;
2. Diagnosis made in 2007, 2008, 2009 or 2010;
3. Written informed consent.
- Exclusion criteriaAtypical Parkinson's Disease (for instance vascular parkinsonism, drug-induced parkinsonism, multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-mrt-2010
- planned closingdate16-jul-2012
- Target number of participants150
- InterventionsNone.
- Primary outcomeInformation is obtained from medical records of General Practitioners, from hospital medical records and during a standardized interview with the patients. To ensure the accuracy of recall information during the interview, particularly for some patients with cognitive deficits, patients are asked to be accompanied by a caregiver. These information is obtained over a 5-year period prior the the year the diagnosis is made. Investigated will be the symptoms, the duration of the preclinical phase, the medical health care resource use and costs.
- Secondary outcomeCost-predicting factors, for instance patient characteristics and medical health care resource use will be identified.
- TimepointsThe information is obtained over a 5-year period prior to the year the diagnosis idiopathic Parkinson's Disease is made.
- Trial web sitewww.atriummc.nl/Onderzoek-Parkinson.18592.0.html
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES V.J.H. Rouvroije
- CONTACT for SCIENTIFIC QUERIESDr. G. Tissingh
- Sponsor/Initiator Atrium Medisch Centrum Parkstad
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medisch Centrum Parkstad
- PublicationsN/A
- Brief summaryThe preclinical phase of idiopathic Parkinson's Disease can be accompanied by different aspecific symptoms and signs. Therefore the delay before diagnosis is made can last months to years. It is expected that the total economic burden of this preclinical phase is high; however, the exact costs are not known. This retrospective study will investigate the symptoms, duration, health care resource use, costs and cost-predicting factors in the 5-year period prior to the diagnosis idiopathic Parkinson's Disease is made. The aim of this study is to increase knowledge about the impact of the preclinical phase. Further more, health practitioners might be able to make an earlier diagnosis and start the correct therapy as soon as possible.

Countries of recruitement: The Netherlands.
- Main changes (audit trail)
- RECORD20-apr-2010 - 9-sep-2010


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