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Active Not Recruiting
NCT06284629
Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes.
Conditions: Parkinson Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Copenhagen University Hospital, Rigshospitalet
Location: Rigshospitalet Glostrup Glostrup Municipality
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
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.
Source: ClinicalTrials.gov (NCT06284629). StuddyBuddy aggregates publicly available trial information.