Remote monitoring app for people with Parkinson's disease
Tests a remote monitoring device in adults with Parkinson's disease.
Key facts
- Who runs it
- DIAMPARK
- Where
- Angers, Bourg-en-Bresse, Caen, Clamart, Le Puy-en-Velay, Montpellier, Nice, Troyes, Valenciennes, and Villeurbanne, FranceSee the 10 sites
- Trial code
- Registry title
- Clinical Evaluation of A neW Management Strategy for Patients With pArKinson's disEase usiNg an Innovative telemonitorING (AWAKENING)
- Status
- Not yet recruiting
- People taking part
- 300 people, planned
- Started
- 1 Jul 2024
- Expected to end
- 1 Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- DIGIPARK MONITOR
- Record updated
- 9 May 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Parkinson's disease who are followed by a neurologist and can use a smartphone, computer or tablet. They take part in remote monitoring of their symptoms.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Parkinson's disease at stage 1.5 to 3 on the Hoehn and Yahr scale.
- Earlier treatment
- Must have been followed by a neurologist for at least one month.
Main reasons for not taking part
- Person under guardianship, curatorship or other measure that removes rights or freedom
- Dementia, mental, cognitive or psychiatric disorder that could affect consent or following the study
- Not independent, according to the investigator, and has no caregiver
- Already in another interventional research study (except NS-PARK's PRECISE-PD cohort)
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Person under guardianship, curatorship or safeguard of justice or any other administrative or judicial measure of deprivation of rights and freedom
- 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
Where in France
- CHU AngersAngers, FranceContact: Frédérique ETCHARY-BOUYXNo longer taking part
- CH FlayriatBourg-en-Bresse, FranceContact: Michel AZARNo longer taking part
- CHU CaenCaen, FranceContact: Claire THIRIEZNo longer taking part
- Clinique du PlateauClamart, FranceContact: Capucine MOUTHON-REIGNIERNo longer taking part
- CH Emile RouxLe Puy-en-Velay, FranceContact: Jérémie DASSANo longer taking part
- Clinique Beau SoleilMontpellier, FranceContact: Valerie COHEN DE COCKNo longer taking part
- CHU NiceNice, FranceContact: Caroline GIORDANANo longer taking part
- CH de TroyesTroyes, FranceContact: René DECOMBENo longer taking part
- Hopital jean BernardValenciennes, FranceContact: Gilles RYCKEWAERTNo longer taking part
- Médipole Hôpital MutulisteVilleurbanne, FranceContact: Adeline GIANINA, MDNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Control armNo study treatment, for comparison
conventional follow-up only, i.e. a consultation with the neurologist every 6 months
- Telemonitoring armTreatment being tested
remote monitoring using the DIGIPARK MONITOR application in addition to conventional monitoring.
Treatment: DIGIPARK MONITOR
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Clinical Evaluation of A neW Management Strategy for Patients With pArKinson's disEase usiNg an Innovative telemonitorING Device : AWAKENING Study
- Plain-language title
- Remote monitoring app for people with Parkinson's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 9 May 2024