Parkinson Disease
Conditions
Keywords
Wearable Devices, Objective measurements, Advanced treatment, Digital health
Brief summary
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.
Detailed description
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. 75 participants will be recruited from the uptake area of the Movement Disorder Clinics (MDC) at Rigshospitalet Glostrup (RHG) and 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 6 months, in which they will have 3 study visits: * Baseline * Clinical visits at month 3 and 6 * Final visit after 6 months They will be asked to wear the device for 6 months. We will then compare decisions made related to changes in medication and referrals to advanced treatment.
Interventions
DEVICENeptune
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 view their motor data, and a physician portal, where the treating physician can view the objective motor data prior to a clinical visit.
Treatment and management according to standard clinical care
Sponsors
Copenhagen University Hospital, Rigshospitalet
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Idiopathic Parkinson's Disease * Taking five or more doses of levodopa daily, or 4 doses levodopa and a COMT-inhibitor * Experiencing fluctuations in motor function with regards to OFF time and/or dyskinesia. * Able and motivated to utilize a digital product, either alone or assisted by a caregiver.
Exclusion criteria
* Consistent use of a wheelchair or walker which may interfere significantly with the remote monitoring of PD motor symptoms. * Lack of understanding and proficiency in the Danish language. * Inability to use wearable devices due to non-compliance, physical and/or skin sensitivity. * Suffering from severe psychiatric disorders. * Otherwise not qualified to receive advanced treatment (e.g., advanced cancer, severe heart failure). * Already undergoing advanced treatment. * Diagnosed with atypical or secondary parkinsonism. * Other patient groups otherwise deemed ineligible by the project manager.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences between groups in proportion of patients referred to evaluation for advanced treatment. | 6 months | Differences in number of referrals based on access to digital measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. | 6 months | Global Sleep Assessment Scale (GSAQ). Every question is scored from 0-3 (highest worst) |
| Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale) | 6 months | Levodopa Equivalent Dose, LED, by use of Tomlinson's scale. |
| System Usability Scale | Completed at last visit of the study | The System Usability Scale (SUS) is a simple, ten-statement questionnaire used to evaluate the usability of a system or product. It is scored from 0-100. |
| Referrals | 6 months | Clinician confidence in referral decision (5-point Likert scale) and reasons for referral |
| Medication adjustment | 6 months | Clinician confidence in changes in oral medication based on wearable data |
| Symptom burden | 6 months | Differences in wearable-based symptom burden (OFF/DYS vs ON time) between groups at the time of referral. |
| Referral time | 6 months | Differences between groups in time from inclusion to referral |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORBo Biering-Soerensen, MD
Copenhagen University Hospital, Rigshospitalet
Outcome results
None listed