Clinical Evaluation of A neW Management Strategy for Patients With pArKinson's disEase usiNg an Innovative telemonitorING (AWAKENING) - Trial NCT06401395

Timeline & Enrollment

Primary Outcome

Clinical effectiveness of telemonitoring on symptom progression in PD patients assessed by Movement Disorder Society- Unified Parkinson's Disease Rating scale (MDS-UPDRS)

Summary

Parkinson's disease (PD) ranks second among neurodegenerative diseases and is a major cause
 of neurological motor disability. The number of PD cases doubled between 1990 and 2016. The
 consequences of PD, including an increased risk of falls, loss of autonomy and reduced
 quality of life, contribute to increased morbidity and mortality. The costs associated with
 falls in the elderly (a fortiori those with PD) and their consequences represent between
 0.85% and 1.5% of total healthcare expenditure.
 
 There is currently no cure for PD. Treatment is symptomatic and depends on the degree of
 functional impairment and the age of onset. After a period of stabilization (state phase) of
 varying length, the clinical situation worsens because of treatment-related motor
 complications (motor fluctuations, on/off phenomena, dyskinesias, under/overdosing) and the
 appearance or worsening of disease-specific signs linked to the pathogenic process. Treatment
 of motor complications involves constantly adjusting doses and dosing schedules to suit each
 individual case, and to take account of variations in the patient's motor status over the
 months. These adjustments must also take into account the non-motor signs of the disease,
 notably thymic fluctuations, treatment-related behavioral disorders, fatigue, sensory and
 pain disorders. Regular follow-up of patients is therefore essential to assess the evolution
 of their symptoms, adjust treatment, adapt therapeutic interventions and improve their
 quality of life. However, most consultations with the neurologist are bi-annual, and because
 of the long time lapse between two consultations, the practitioner often has only incomplete
 information on the evolution of symptoms.
 
 To help fill these gaps, advances in digital health technologies, with the development of
 telemonitoring solutions, enable patients to be monitored remotely and provide a potentially
 more robust amount of information relating to the severity of the disease and its evolution
 over time. In this sense, remote monitoring in PD would enable the neurologist to readjust
 treatment at the right time and in the most appropriate way. This will be done by means of a
 weekly questionnaire (adapted from the clinical examination via the MDS-UPDRS scale)
 completed by the patient via a mobile application.
 
 Remote monitoring of patients should improve their symptom management and quality of life,
 hence the interest in an intervention offering a remote monitoring service: DIGIPARK MONITOR.

ICD-10 Classifications