Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neptune, Standard clinical care.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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
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.
Interventions
- Device Neptune
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. - Other Standard clinical care
Treatment and management according to standard clinical care
Primary outcome measures
- 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]
Secondary outcome measures (7)
- Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. [Time frame: 1 year]
- Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. [Time frame: 1 year]
- Changes in type of, frequency and dose of medication (calculated 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. [Time frame: 1 year]
- Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. [Time frame: 1 year]
- Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. [Time frame: 1 year]
- Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 2 centers
- Rigshospitalet Glostrup — Glostrup Municipality
- Odense University Hospital — Odense
Identifiers
NCT: NCT06284629 · PD-DigiCare