West Sweden Parkinson Objective Measurement Registry Study

NCT ID: NCT03130595

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-26
• Study Completion Date: 2030-12-31

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.

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.

Conditions

Parkinson Disease; Parkinsonism; Parkinsonian Disorders

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Filip Bergquist

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filip Bergquist, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

PARKreg

Identifier Type: REGISTRY

Identifier Source: secondary_id

WestPORTS

Identifier Type: -

Identifier Source: org_study_id