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

NCT06284629 | Not Yet Recruiting

• 1 other identifier: PD-DigiCare
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

Wearable Devices; Objective measurements; Advanced treatment; Digital health

Outcome Measures

Primary Outcomes (1)

• 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 spent in the ON state without dyskinesias, as measured by the Neptune algorithm

  1 year

Secondary Outcomes (7)

• Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.

  1 year

• 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

• Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.

  1 year

• Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

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

Device: Neptune

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard clinical care

Interventions

Neptune DEVICE

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.

Also known as: Neptune Care

Intervention

Standard clinical care OTHER

Treatment and management according to standard clinical care

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Odense University Hospital: collaborator

Study Sites (2)

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Bo Biering-Soerensen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolaj la Cour Karottki, MD

CONTACT

40432773; nikolaj.folke.la.cour.karottki.01@regionh.dk

Bo Biering-Soerensen, MD

CONTACT

40432773; bo.biering-soerensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPG, associate professor

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 29, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be published as supplementary material to publications.

Locations

DK (2)