Parkinson DiseasePD-DigiCareNCT06284629
Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes.
A study testing Neptune and Standard clinical care in people with Parkinson Disease, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Neptune and Standard clinical care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Nov 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Idiopathic Parkinson's Disease
- Taking five or more doses of levodopa daily, or 4 doses levodopa and a COMT-inhibitor
- Experiencing fluctuations in motor function with regards to OFF time and/or dyskinesia.
- Able and motivated to utilize a digital product, either alone or assisted by a caregiver.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet Glostrup
Glostrup Municipality, 2600
Odense University Hospital
Odense
About this study
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.
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.
Read the 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.
75 participants will be recruited from the uptake area of the Movement Disorder Clinics (MDC) at Rigshospitalet Glostrup (RHG) and 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 6 months, in which they will have 3 study visits:
- Baseline
- Clinical visits at month 3 and 6
- Final visit after 6 months
They will be asked to wear the device for 6 months. We will then compare decisions made related to changes in medication and referrals to advanced treatment.
- Conditions
- Parkinson Disease
- Being tested
- Neptune, Standard clinical care
- Keywords
- Wearable Devices, Objective measurements, Advanced treatment, Digital health
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeptuneDevice
Also called Neptune Care
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 view their motor data, and a physician portal, where the treating physician can view the objective motor data prior to a clinical visit.
Standard clinical careOther
Treatment and management according to standard clinical care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention consists of a wrist-worn wearable sensor that tracks motor symptoms and an app for patient-reported outcomes. Receives: 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. Receives: Other: Standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between groups in proportion of patients referred to evaluation for advanced treatment.
Differences in number of referrals based on access to digital measurements
Measured: 6 months
Secondary outcomes (12)
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)
Measured: 6 months
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Non-Motor Symptom Scale (NMSS). Scored from 0-360 (highest worst)
Measured: 6 months
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.
Measured: 6 months
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)
Measured: 6 months
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Parkinson's Disease Questionnaire (PDQ-39). Scored from 0-100 (highest worst)
Measured: 6 months
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).
Measured: 6 months
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)
Measured: 6 months
System Usability Scale
The System Usability Scale (SUS) is a simple, ten-statement questionnaire used to evaluate the usability of a system or product. It is scored from 0-100.
Measured: Completed at last visit of the study
Referrals
Clinician confidence in referral decision (5-point Likert scale) and reasons for referral
Measured: 6 months
Medication adjustment
Clinician confidence in changes in oral medication based on wearable data
Measured: 6 months
Symptom burden
Differences in wearable-based symptom burden (OFF/DYS vs ON time) between groups at the time of referral.
Measured: 6 months
Referral time
Differences between groups in time from inclusion to referral
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Bo Biering-Soerensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bo Biering-Soerensen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284629
- Sponsor's protocol ID
- PD-DigiCare
- Acronym
- PD-DigiCare
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06284629
- Acronym / sponsor ID
- PD-DigiCare / PD-DigiCare
- Conditions
- Parkinson Disease
- Keywords
- Wearable Devices, Objective measurements, Advanced treatment, Digital health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
75 participants will be recruited from the uptake area of the Movement Disorder Clinics (MDC) at Rigshospitalet Glostrup (RHG) and 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 6 months, in which they will have 3 study visits:
- Baseline
- Clinical visits at month 3 and 6
- Final visit after 6 months
They will be asked to wear the device for 6 months. We will then compare decisions made related to changes in medication and referrals to advanced treatment.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: NeptuneThe intervention consists of a wrist-worn wearable sensor that tracks motor symptoms and an app for patient-reported outcomes. |
| Standard of Care | Active comparator | Other: Standard clinical careThe control group will wear the wrist-worn wearable sensor, but not be able to view the tracked data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Idiopathic Parkinson's Disease
- Taking five or more doses of levodopa daily, or 4 doses levodopa and a COMT-inhibitor
- Experiencing fluctuations in motor function with regards to OFF time and/or dyskinesia.
- Able and motivated to utilize a digital product, either alone or assisted by a caregiver.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeptuneAlso: Neptune CareNeptune 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 view their motor data, and a physician portal, where the treating physician can view the objective motor data prior to a clinical visit. | Device | Intervention |
| Standard clinical careTreatment and management according to standard clinical care | Other | Standard of Care |
Primary outcome
Differences between groups in proportion of patients referred to evaluation for advanced treatment.
Time frame: 6 months
Differences in number of referrals based on access to digital measurements
12 secondary outcomes
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Time frame: 6 months
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Time frame: 6 months
Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale)
Time frame: 6 months
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Time frame: 6 months
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Time frame: 6 months
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Time frame: 6 months
Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention.
Time frame: 6 months
System Usability Scale
Time frame: Completed at last visit of the study
Referrals
Time frame: 6 months
Medication adjustment
Time frame: 6 months
Symptom burden
Time frame: 6 months
Referral time
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Biering-Soerensen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neptune and Standard clinical care in people with Parkinson Disease, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between groups in proportion of patients referred to evaluation for advanced treatment. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.