West Sweden Parkinson Objective Measurement Registry Study (WestPORTS)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease; Parkinsonian Disorders; Parkinsonism

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 320

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, 41345
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

25% of the population described by the inclusion criteria

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
PD outpatients in West Sweden; 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?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Göteborg University
• Investigators: Principal Investigator: Filip Bergquist, MD, PhD, Göteborg University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2017
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): December 1, 2030

Study Registration Dates

• First Submitted: April 22, 2017
• First Submitted That Met QC Criteria: April 22, 2017
• First Posted (ACTUAL): April 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: accelerometry; Parkinson Kinetigraph
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Parkinsonian Disorders
• Other Study ID Numbers: WestPORTS; PARKreg (REGISTRY: Svenska Parkinsonregistret)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Clinical registry data will be immediately available as part of the national Parkinson Registry. Study specific data from objective measurements will be made available within the registry one year after final subject has been recruited. Access to data requires ethical permission and permission from the registry scientific committee SWEPAR.
• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: Access to data requires ethical permission and permission from the registry scientific committee SWEPAR.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No