Status:
RECRUITING
Quality-of-Life Index (Q-Index)
Lead Sponsor:
Koios Care
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-70 years
Brief Summary
The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of peo...
Detailed Description
The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of peo...
Eligibility Criteria
Inclusion
- Males and females between the ages of 30 and 75
- Agree to download and install the Koios Care application to their personal Android smartphone.
- People diagnosed with idiopathic PD based on the MDS-PD criteria. The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present, without any other known or suspected cause of Parkinson's Disease.
- o PD patients that are under the effects of a Deep Brain Stimulation (DBS) device or a levodopa pump (duodopa or lecigimon). Given that all other conditions are also met.
- Score between one-and-a-half (1.5) and three (3) at the H\&Y rating scale in the "ON" state (population A)
- Score of one (1) at the H\&Y rating scale in the "ON" state (population B)
Exclusion
- The candidate cannot speak or comprehend the French/Dutch (depending on the clinical site s/he belongs to) language at a sufficient level.
- The reluctance of the candidate or her/his inability to provide written consent (e.g., due to mental health problems or severe physical disabilities).
- The candidate is not an Android smartphone owner and user for at least six (6) months.
- The candidate's Android smartphone is not compatible with the Koios Care application.
- The candidate suffers from dementia as judged by the investigator. For this we will use MMSE score with a cut-off value ≥ 24.
- The candidate has exhibited uncontrolled/extreme measures of depression as judged by the expert investigator, e.g., self-harm, suicide attempts or patient admitted to the hospital for a similar reason.
- \-- If the participant develops such behavior or s/he is admitted to the hospital for the above reasons during the study, then the candidate is immediately removed from the study.
- Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the investigator.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT06209502
Start Date
November 1 2023
End Date
October 31 2024
Last Update
January 17 2024
Active Locations (1)
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1
AZ Delta
Roeselare, Belgium, 8800