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WestPORTS: West Sweden Parkinson Objective Measurement Registry Study

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03130595
Collaborator
Göteborg University (Other)
320
Enrollment
1
Location
163.2
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    320 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    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
    Actual Study Start Date :
    Apr 26, 2017
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Objective measurement of spontaneous movement patterns [144 hours]

      Parkinson Kinetigraph

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sahlgrenska University Hospital Göteborg Sweden 41345

    Sponsors and Collaborators

    • Sahlgrenska University Hospital, Sweden
    • Göteborg University

    Investigators

    • Principal Investigator: Filip Bergquist, MD, PhD, Göteborg University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Filip Bergquist, Associate Professor, Sahlgrenska University Hospital, Sweden
    ClinicalTrials.gov Identifier:
    NCT03130595
    Other Study ID Numbers:
    • WestPORTS
    • PARKreg
    First Posted:
    Apr 26, 2017
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Filip Bergquist, Associate Professor, Sahlgrenska University Hospital, Sweden
    accelerometry
    Parkinson Kinetigraph
    Additional relevant MeSH terms:
    Parkinson Disease
    Parkinsonian Disorders

    Study Results

    No Results Posted as of May 4, 2022