West Sweden Parkinson Objective Measurement Registry Study

Study Overview
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Brief Summary
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WestPORTS will recruit a randomly selected population consisting of 25% of all individuals with Parkinson's disease (ICD G209) that have visited any of the seven major outpatient neurology or geriatrics clinics in West Sweden (population 1.7M) during a predefined 12 month period between Sept 2016 and April 2018. Baseline clinical and demographic data will be collected along with a 6 x 24h accelerometry recording using the Parkinson Kinetigraph (Global Kinetics). Repeated data collections will be made with regular intervals of up to 2 years as long as subjects are alive and willing.

Detailed Description
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The following data will be collected at baseline: Date of birth Handedness Family history of Parkinson's disease Time of first motor symptom onset Laterality of symptom onset Time of diagnosis Time of first pharmacological intervention (if applicable) First antiparkinsonian drug The following data will be collected at every visit/update Current living conditions Current non motor complications Current medications Hoehn and Yahr staging Clinical Impression of Severity Index in Parkinson's disease (CISI-PD) Patient self assessments: PDQ8, NMS-Questionnaire, EQ5D-5L, Patient Reported Outcome in Parkinson's Disease (PRO-PD) Parkinson Kinetigraph (PKG) accelerometry based recording of spontaneous movement patterns over a 6x24h period. The following indices will be extracted: median bradykinesia score (BKS), median dyskinesia score (DKS), Fluctuation Dyskinesia Score (FDS), Percent daytime with Immobility (PTI%), Percent daytime with tremor (PTT%). The primary analysis will be descriptive and include demographic composition of the population, clinical characteristics and objective measurement data. In addition to indices a standardized qualitative assessment of PKG recordings will be made to identify motor fluctuations. Correlations between clinical ratings, patient reported outcomes, disease duration, age, medication and objective measurement indices will be studied In the prospective phase of the study the development of objective movement recordings will be studied along with the development of clinical ratings and patient reported outcomes.

Official Title
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West Sweden Parkinson Objective Measurement Registry Study - an Observational Cohort Study of the Prevalence and Development of Motor Symptoms Assessed With Automated Accelerometry in People With Parkinson's Disease in West Sweden

Conditions
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Parkinson Disease, Parkinsonism, Parkinsonian Disorders

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical record with a G209 (Parkinson's disease) diagnosis A visit to one of the participating outpatient clinics in West Sweden within the last 6 months Informed consent Exclusion Criteria: Diagnosis revised before visit.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD outpatients in West Sweden<br>Cross-sectional random sample of patients with PD that have visited outpatient clinics in West Sweden in the last 6+6 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective measurement of spontaneous movement patterns | Parkinson Kinetigraph | 144 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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accelerometry, Parkinson Kinetigraph