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

Clinical Evaluation of A neW Management Strategy for Patients With pArKinson's disEase usiNg an Innovative telemonitorING Device : AWAKENING Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: DIGIPARK MONITOR

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magali BALAVOINE; Phone Number: +33241682940; Email: m.balavoine@ilcgroupe.fr

Study Locations

• France
  • Angers, France
    • Chu Angers
    • Contact: Frédérique ETCHARY-BOUYX
    • Principal Investigator: Frédérique ETCHARY-BOUYX, MD
  • Bourg-en-Bresse, France
    • CH Flayriat
    • Contact: Michel AZAR
    • Principal Investigator: Michel AZAR, MD
  • Caen, France
    • CHU CAEN
    • Contact: Claire THIRIEZ
    • Principal Investigator: Claire THIRIEZ, MD
  • Clamart, France
    • Clinique du Plateau
    • Contact: Capucine MOUTHON-REIGNIER
    • Principal Investigator: Capucine MOUTHON-REIGNIER, MD
  • Le Puy-en-Velay, France
    • CH Emile Roux
    • Contact: Jérémie DASSA
    • Principal Investigator: Jérémie DASSA, MD
  • Montpellier, France
    • Clinique Beau Soleil
    • Contact: Valerie COHEN DE COCK
    • Principal Investigator: Valerie COHEN DE COCK, MD
  • Nice, France
    • CHU Nice
    • Contact: Caroline GIORDANA
    • Principal Investigator: Caroline GIORDANA, MD
  • Troyes, France
    • CH de Troyes
    • Contact: René DECOMBE
    • Principal Investigator: René DECOMBE, MD
  • Valenciennes, France
    • Hopital Jean Bernard
    • Contact: Gilles RYCKEWAERT
    • Principal Investigator: Gilles RYCKEWAERT, MD
  • Villeurbanne, France, 69100
    • Médipole Hôpital Mutuliste
    • Contact: Adeline GIANINA, MD
    • Principal Investigator: Adeline GIANINA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; conventional follow-up only, i.e. a consultation with the neurologist every 6 months
Experimental: Telemonitoring arm; remote monitoring using the DIGIPARK MONITOR application in addition to conventional monitoring.	Device: DIGIPARK MONITOR; remote monitoring application (containing a questionnaire to assess the patient's symptoms, adapted from the clinical examination using the MDS-UPDRS scale). This questionnaire will be completed weekly for 12 months via the DIGIPARK MONITOR application by the patient or caregiver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical effectiveness of telemonitoring on symptom progression in PD patients assessed by Movement Disorder Society- Unified Parkinson's Disease Rating scale (MDS-UPDRS)	total clinical examination score using the Movement Disorder Society- Unified Parkinson's Disease Rating scale (MDS-UPDRS). Score range from 0 to 200. A high score indicates clinical deterioration	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medico-economic impact	Average total cost at 12 months in each group	12 months
Evolution of PD patients' symptoms assessed by Movement Disorder Society- Unified Parkinson's Disease Rating scale (MDS-UPDRS)	Total clinical examination score using the Movement Disorder Society- Unified Parkinson's Disease Rating scale (MDS-UPDRS). Score range from 0 to 200. A high score indicates clinical deterioration	12 months
Specific quality of Life assessed by Parkinson Disease Questionnaire (PD-Q39).	score of Parkinson Disease Questionnaire (PD-Q39). Score range from 0 to 100. A high score indicates a deterioration	12 months
General quality of Life assessed by EuroQol-5 dimensions questionnaire	Score of EuroQol-5 dimensions questionnaire. Score range from 0 to 100. A high score indicates a improvement	12 months
Organizational impact assessed by the number of consultation that led to a paramedical and/or drug treatment rehabilitation between semi-annual consultations	Percentage of patients who had a consultation that led to a paramedical and/or drug treatment rehabilitation between semi-annual consultations	12 months
Usability assessed by System Usability Scale.	System Usability Scale. Score range from 1 to 100. A high score indicates a improvement	12 months
User's satisfaction assessed by a spécific questionnaire created for the study	Satisfaction questionnaire created specifically for the study.Score range from 1 to 100. A high score indicates a improvement	12 months

Collaborators and Investigators

• Sponsor: DIAMPARK
• Collaborators: Weprom; Digital Medical Hub
• Investigators: Principal Investigator: Adeline GIANINA, Medipole Hopital Mutualiste

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Telemonitoring; Parkinson disease; Symptom management
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: DigiParkMonitor_1.0_Awakening; 2024-A00464-43 (Other Identifier: French Health Products Safety Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No