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

NCT06401395 | Not Yet Recruiting

• 2 other identifiers: DigiParkMonitor_1.0_Awakening2024-A00464-43
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; Telemonitoring; Symptom management; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Evolution of PD patients' symptoms assessed by Movement Disorder Society- Unified Parkinson's Disease Rating scale (MDS-UPDRS)

  12 months

• Specific quality of Life assessed by Parkinson Disease Questionnaire (PD-Q39).

  12 months

• General quality of Life assessed by EuroQol-5 dimensions questionnaire

  12 months

• Organizational impact assessed by the number of consultation that led to a paramedical and/or drug treatment rehabilitation between semi-annual consultations

  12 months

• Medico-economic impact

  12 months

Study Arms (2)

Control arm

NO INTERVENTION

conventional follow-up only, i.e. a consultation with the neurologist every 6 months

Telemonitoring arm

EXPERIMENTAL

remote monitoring using the DIGIPARK MONITOR application in addition to conventional monitoring.

Device: DIGIPARK MONITOR

Interventions

DIGIPARK MONITOR DEVICE

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.

Telemonitoring arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DIAMPARK: lead
• Weprom: collaborator
• Digital Medical Hub: collaborator

Study Sites (10)

CHU Angers

Angers, France

Location

CH Flayriat

Bourg-en-Bresse, France

Location

CHU Caen

Caen, France

Location

Clinique du Plateau

Clamart, France

Location

CH Emile Roux

Le Puy-en-Velay, France

Location

Clinique Beau Soleil

Montpellier, France

Location

CHU Nice

Nice, France

Location

CH de Troyes

Troyes, France

Location

Hopital jean Bernard

Valenciennes, France

Location

Médipole Hôpital Mutuliste

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Adeline GIANINA

  Medipole Hopital Mutualiste

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magali BALAVOINE

CONTACT

+33241682940; m.balavoine@ilcgroupe.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)