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

Rigshospitalet

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Other: Standard clinical care; Device: Neptune

Study type: Interventional

Funder types: Other

Identifiers

NCT06284629

PD-DigiCare

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention consists of a wrist-worn wearable sensor that tracks motor symptoms and an app for patient-reported outcomes.

Treatment:

Device: Neptune

Standard of Care

Active Comparator group

Description:

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

Treatment:

Other: Standard clinical care