PD-DigiCare: Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes - a Multicentre Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Differences between groups in algorithm-based motor symptom burden (time spent in the ON state without dyskinesias) at referral to evaluation for advanced treatment.
Study Overview
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.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
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 Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with Idiopathic Parkinson's Disease
- •Taking five or more doses of levodopa daily
- •Experiencing fluctuations in motor function with regards to OFF time and/or dyskinesia.
- •Able 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.
Arms & Interventions
Intervention
The intervention consists of a wrist-worn wearable sensor that tracks motor symptoms and an app for patient-reported outcomes.
Intervention: Neptune (Device)
Standard of Care
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
Intervention: Standard clinical care (Other)
Outcomes
Primary Outcomes
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 Frame: 1 year
Time spent in the ON state without dyskinesias, as measured by the Neptune algorithm
Secondary Outcomes
- Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.(1 year)
- Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale)(1 year)
Investigators
Bo Biering-Soerensen
MD, MPG, associate professor
Rigshospitalet, Denmark