protocolSection identificationModule nctId: NCT06284629, orgStudyIdInfo id: PD-DigiCare, briefTitle: Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes., acronym: PD-DigiCare, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: Odense University Hospital, collaborators name: Zealand University Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: 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., enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Neptune, interventions name: Standard clinical care, outcomesModule primaryOutcomes 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., secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., secondaryOutcomes measure: Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale), secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet Glostrup, city: Glostrup, zip: 2600, country: Denmark, contacts name: Nikolaj la Cour Karottki, MD, role: CONTACT, phone: 40432773, email: nikolaj.folke.la.cour.karottki.01@regionh.dk, geoPoint lat: 55.6666, lon: 12.40377, locations facility: Odense University Hospital, city: Odense, country: Denmark, contacts name: Morten Blaabjerg, MD, role: CONTACT, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Zealand University Hospital, Roskilde, city: Roskilde, country: Denmark, contacts name: Helle Thagesen, MD, role: CONTACT, geoPoint lat: 55.64152, lon: 12.08035, hasResults: False