Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-02
Brief Title:
Clinical Evaluation of A neW Management Strategy for Patients With pArKinsons disEase usiNg an Innovative telemonitorING AWAKENING
Sponsor:
DIAMPARK
Organization:
DIAMPARK
Study Overview
Official Title:
Clinical Evaluation of A neW Management Strategy for Patients With pArKinsons disEase usiNg an Innovative telemonitorING Device AWAKENING Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AWAKENING
Brief Summary:
Parkinsons 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 085 and 15 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 onoff phenomena dyskinesias underoverdosing 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 patients 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
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 onoff phenomena dyskinesias underoverdosing 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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00464-43 | OTHER | French Health Products Safety Agency | None |