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

Parkinson Disease Clinical Trial

— PD-DigiCare  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06284629
• Other study ID #: PD-DigiCare
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: June 2024
• Source: Rigshospitalet, Denmark
• Contact: Nikolaj la Cour Karottki, MD
• Phone: 40432773
• Email: nikolaj.folke.la.cour.karottki.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet Glostrup	Glostrup
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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