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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Neptune; Other: Standard clinical care

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), Odense University Hospital (OUH) and Zealand University Hospital Roskilde (SUH-R), as well as from 4 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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nikolaj la Cour Karottki, MD; Phone Number: 40432773; Email: nikolaj.folke.la.cour.karottki.01@regionh.dk
• Study Contact Backup: Name: Bo Biering-Soerensen, MD; Phone Number: 40432773; Email: bo.biering-soerensen@regionh.dk

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Rigshospitalet Glostrup
    • Contact: Nikolaj la Cour Karottki, MD; Phone Number: 40432773; Email: nikolaj.folke.la.cour.karottki.01@regionh.dk
  • Odense, Denmark
    • Odense University Hospital
    • Contact: Morten Blaabjerg, MD
  • Roskilde, Denmark
    • Zealand University Hospital, Roskilde
    • Contact: Helle Thagesen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention consists of a wrist-worn wearable sensor that tracks motor symptoms and an app for patient-reported outcomes.	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 Names: Neptune Care
Active Comparator: 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	Other: Standard clinical care; Treatment and management according to standard clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.	Global Sleep Assessment Scale (GSAQ). Every question is scored from 0-3 (highest worst)	1 year
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.	Non-Motor Symptom Scale (NMSS). Scored from 0-360 (highest worst)	1 year
Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale)	Levodopa Equivalent Dose, LED, by use of Tomlinson's scale.	1 year
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.	Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Scored from 0-52 (UPDRS-II), 0-132 (UPDRS-III) and 0-44 (UPDRS-IV) (highest worst)	1 year
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.	Parkinson's Disease Questionnaire (PDQ-39). Scored from 0-100 (highest worst)	1 year
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.	EuroQol Questionnaire (EQ5D-5L). Scored from 0-1 and 0-100 (highest best).	1 year
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.	Patient Global Impressions Scale - Improvement score (measurements of QoL) (PGI-I). Every question is scored from 1-7 (highest worst)	1 year

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Odense University Hospital; Zealand University Hospital
• Investigators: Principal Investigator: Bo Biering-Soerensen, MD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Objective measurements; Digital health; Wearable Devices; Advanced treatment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PD-DigiCare

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data will be published in anonymized format as supplementary material to publications. Study protocol, SAP, ICF and analytic code will be available upon request.
• IPD Sharing Time Frame: Data will be published as supplementary material to publications.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No