Clinical trial NCT06401395: Clinical Evaluation of A neW Management Strategy for Patients With pArKinson's disEase usiNg an Innovative telemonitorING (AWAKENING)
Official title: Clinical Evaluation of A neW Management Strategy for Patients With pArKinson's disEase usiNg an Innovative telemonitorING Device : AWAKENING Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
Telemonitoring
Symptom management
Quality of life
Lead sponsor: DIAMPARK
Sponsor class: INDUSTRY
Collaborators: name: Weprom
name: Digital Medical Hub
First posted: 2024-05-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years ;
* Parkinson's disease according to MDS diagnostic criteria ;
* Classified as stage 1.5 to 3 according to the Hoehn and Yahr stages ;
* Followed by a neurologist since at least one month;
* Equipped with a smartphone or a computer or tablet with internet/cellular data access via the latter (or with the caregiver) ;
* Resident on French territory affiliated to a social security scheme.

Exclusion Criteria:

* Person under guardianship, curatorship or safeguard of justice or any other administrative or judicial measure of deprivation of rights and freedom;
* Patient suffering from dementia, mental disorders, cognitive disorders, or psychiatric pathology that could compromise the patient's informed consent and/or compliance with the study protocol;
* Patient deemed non-autonomous by the investigator and without a caregiver;
* Patient already included in another interventional research study, with the exception of NS-PARK's "PRECISE-PD" cohort.

Primary outcomes:
measure: Clinical effectiveness of telemonitoring on symptom progression in PD patients assessed by Movement Disorder Society- Unified Parkinson's Disease Rating scale (MDS-UPDRS)
timeFrame: 6 months
Secondary outcomes:
measure: Evolution of PD patients' symptoms assessed by Movement Disorder Society- Unified Parkinson's Disease Rating scale (MDS-UPDRS)
timeFrame: 12 months
measure: Specific quality of Life assessed by Parkinson Disease Questionnaire (PD-Q39).
timeFrame: 12 months
measure: General quality of Life assessed by EuroQol-5 dimensions questionnaire
timeFrame: 12 months
measure: Organizational impact assessed by the number of consultation that led to a paramedical and/or drug treatment rehabilitation between semi-annual consultations
timeFrame: 12 months
measure: Medico-economic impact
timeFrame: 12 months
measure: Usability assessed by System Usability Scale.
timeFrame: 12 months
measure: User's satisfaction assessed by a spécific questionnaire created for the study
timeFrame: 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bourg-en-Bresse
country: France
facility: CH Flayriat
city: Caen
country: France
facility: CHU Caen
city: Clamart
country: France
facility: Clinique du Plateau
city: Le Puy-en-Velay
country: France
facility: CH Emile Roux
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Nice
country: France
facility: CHU Nice
city: Troyes
country: France
facility: CH de Troyes
city: Valenciennes
country: France
facility: Hopital jean Bernard
city: Villeurbanne
country: France
facility: Médipole Hôpital Mutuliste
Study officials:
affiliation: Medipole Hopital Mutualiste
name: Adeline GIANINA
role: PRINCIPAL_INVESTIGATOR
References: