Clinical trial NCT06284629: Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Wearable Devices
Objective measurements
Advanced treatment
Digital health
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2024-02-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences between groups in algorithm-based motor symptom burden (time spent in the ON state without dyskinesias) at referral to evaluation for advanced treatment.
timeFrame: 1 year
Secondary outcomes:
measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
timeFrame: 1 year
measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
timeFrame: 1 year
measure: Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale)
timeFrame: 1 year
measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
timeFrame: 1 year
measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
timeFrame: 1 year
measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
timeFrame: 1 year
measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
timeFrame: 1 year
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Bo Biering-Soerensen, MD
role: PRINCIPAL_INVESTIGATOR
References: