NCT06284629

Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes.

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-02-29
• Last updated: 2024-06-21

Locations

2 sites across 1 country: Denmark