The overall aim of the trial is to compare the efficacy of using wearables and patient-reported outcome measures versus standard care in enhancing the timeliness of referrals to advanced monitoring of treatments for people with Parkinson's Disease.
The study is a multicentre, parallel group, randomized controlled trial, investigating the value of using wearable devices and electronic patient-reported outcome measurements to improve clinical decision-making related to people with Parkinson's Disease. Data from a wearable device and a mobile app will be compared to current standard of care. 90 participants will be recruited from the uptake area of the Movement Disorder Clinics (MDC) at Rigshospitalet Glostrup (RHG) and Odense University Hospital (OUH), as well as from 5 private practice neurologists in Denmark. They will equally be randomized to one of two groups: Intervention or Standard of Care. Each participant will take part of the trial for one year, in which they will have 5 study visits: * Baseline * Clinical visits every 3 months (months 3, 6 and 9) * Final visit after 12 months They will be asked to wear the device and report symptoms in the app for one year. We will then compare decisions made related to changes in medication and referrals to advanced treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Neptune is a software algorithm that utilizes data from wrist-worn sensors to track Parkinson motor symptoms and displays them in an easy to understand graph. Neptune Care is a mobile app that includes a patient portal, where patients can self-report symptoms, view their motor data and get medication reminders, and a physician portal, where the treating physician can view the objective motor data and patient-reported outcomes prior to a clinical visit.
Treatment and management according to standard clinical care
Rigshospitalet Glostrup
Glostrup Municipality, Denmark
Odense University Hospital
Odense, Denmark
Differences between groups in algorithm-based motor symptom burden (time spent in the ON state without dyskinesias) at referral to evaluation for advanced treatment.
Time spent in the ON state without dyskinesias, as measured by the Neptune algorithm
Time frame: 1 year
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Global Sleep Assessment Scale (GSAQ). Every question is scored from 0-3 (highest worst)
Time frame: 1 year
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Non-Motor Symptom Scale (NMSS). Scored from 0-360 (highest worst)
Time frame: 1 year
Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale)
Levodopa Equivalent Dose, LED, by use of Tomlinson's scale.
Time frame: 1 year
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Scored from 0-52 (UPDRS-II), 0-132 (UPDRS-III) and 0-44 (UPDRS-IV) (highest worst)
Time frame: 1 year
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Parkinson's Disease Questionnaire (PDQ-39). Scored from 0-100 (highest worst)
Time frame: 1 year
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
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EuroQol Questionnaire (EQ5D-5L). Scored from 0-1 and 0-100 (highest best).
Time frame: 1 year
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Patient Global Impressions Scale - Improvement score (measurements of QoL) (PGI-I). Every question is scored from 1-7 (highest worst)
Time frame: 1 year