Parkinson DiseaseAWAKENINGNCT06401395
Clinical Evaluation of A neW Management Strategy for Patients With pArKinson's disEase usiNg an Innovative telemonitorING (AWAKENING)
A study testing DIGIPARK MONITOR in people with Parkinson Disease, run by DIAMPARK at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- DIGIPARK MONITOR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 10 sitesFrance
- Study dates
- 1 Jul 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites
CHU Angers
Angers
Frédérique ETCHARY-BOUYX
Frédérique ETCHARY-BOUYX, MD
CH Flayriat
Bourg-en-Bresse
Michel AZAR
Michel AZAR, MD
CHU Caen
Caen
Claire THIRIEZ
Claire THIRIEZ, MD
Clinique du Plateau
Clamart
Capucine MOUTHON-REIGNIER
Capucine MOUTHON-REIGNIER, MD
CH Emile Roux
Le Puy-en-Velay
Jérémie DASSA
Jérémie DASSA, MD
Clinique Beau Soleil
Montpellier
Valerie COHEN DE COCK
Valerie COHEN DE COCK, MD
CHU Nice
Nice
Caroline GIORDANA
Caroline GIORDANA, MD
CH de Troyes
Troyes
René DECOMBE
René DECOMBE, MD
Hopital jean Bernard
Valenciennes
Gilles RYCKEWAERT
Gilles RYCKEWAERT, MD
Médipole Hôpital Mutuliste
Villeurbanne, 69100
Adeline GIANINA, MD
Adeline GIANINA, MD
About this study
Official title: 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.
Read more
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
- Being tested
- DIGIPARK MONITOR
- Keywords
- Parkinson disease, Telemonitoring, Symptom management, Quality of life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIGIPARK MONITORDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DIGIPARK MONITOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Medico-economic impact
Average total cost at 12 months in each group
Measured: 12 months
Usability assessed by System Usability Scale.
System Usability Scale. Score range from 1 to 100. A high score indicates a improvement
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DIAMPARK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Weprom, Digital Medical Hub
- Responsible party
- Sponsor
- Investigators
- Adeline GIANINA, Principal investigator, Medipole Hopital Mutualiste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401395
- Sponsor's protocol ID
- DigiParkMonitor_1.0_Awakening
- Other IDs
- 2024-A00464-43
- Acronym
- AWAKENING
- Status last verified
- Apr 2024
- First submitted
- 2 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of A neW Management Strategy for Patients With pArKinson's disEase usiNg an Innovative telemonitorING Device : AWAKENING Study
- ClinicalTrials.gov ID
- NCT06401395
- Acronym / sponsor ID
- AWAKENING / DigiParkMonitor_1.0_Awakening
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Telemonitoring, Symptom management, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- DIAMPARKIndustry (pharma, biotech, devices)
- Collaborators
- Weprom, Digital Medical Hub
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –conventional follow-up only, i.e. a consultation with the neurologist every 6 months |
| Telemonitoring arm | Experimental | Device: DIGIPARK MONITORremote monitoring using the DIGIPARK MONITOR application in addition to conventional monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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) ;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIGIPARK MONITORremote 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. | Device | Telemonitoring arm |
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)
Time frame: 6 months
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
7 secondary outcomes
Evolution of PD patients' symptoms assessed by Movement Disorder Society- Unified Parkinson's Disease Rating scale (MDS-UPDRS)
Time frame: 12 months
Specific quality of Life assessed by Parkinson Disease Questionnaire (PD-Q39).
Time frame: 12 months
General quality of Life assessed by EuroQol-5 dimensions questionnaire
Time frame: 12 months
Organizational impact assessed by the number of consultation that led to a paramedical and/or drug treatment rehabilitation between semi-annual consultations
Time frame: 12 months
Medico-economic impact
Time frame: 12 months
Usability assessed by System Usability Scale.
Time frame: 12 months
User's satisfaction assessed by a spécific questionnaire created for the study
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adeline GIANINA principal investigator
Medipole Hopital Mutualiste
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIGIPARK MONITOR in people with Parkinson Disease, run by DIAMPARK at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali BALAVOINE (+33241682940, m.balavoine@ilcgroupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effectiveness of telemonitoring on symptom progression in PD patients assessed by Movement Disorder Society- Unified Parkinson's Disease Rating scale (MDS-UPDRS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.