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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention consists of a wrist-worn wearable sensor that tracks motor symptoms and an app for patient-reported outcomes. |
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| Standard of Care | Active Comparator | The control group will wear the wrist-worn wearable sensor, but not be able to view the tracked data. They will report symptoms in the app, but the patient-reported outcomes won't be included in the clinical visits during the trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neptune | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolaj la Cour Karottki, MD | Contact | 40432773 | nikolaj.folke.la.cour.karottki.01@regionh.dk | |
| Bo Biering-Soerensen, MD | Contact | 40432773 | bo.biering-soerensen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Bo Biering-Soerensen, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet Glostrup | Glostrup Municipality | 2600 | Denmark |
Study data will be published in anonymized format as supplementary material to publications. Study protocol, SAP, ICF and analytic code will be available upon request.
Data will be published as supplementary material to publications.
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Participants and physicians will be blinded to device and app data in the control group. Blinding of the group allocation is not possible due to the investigated device.
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| Standard clinical care | Other | Treatment and management according to standard clinical care |
|
Non-Motor Symptom Scale (NMSS). Scored from 0-360 (highest worst) |
| 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. | 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) | 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) | 1 year |
| Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. | EuroQol Questionnaire (EQ5D-5L). Scored from 0-1 and 0-100 (highest best). | 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) | 1 year |
| Odense University Hospital | Odense | Denmark |
|
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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