Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease (@ctipark)
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|ClinicalTrials.gov Identifier: NCT03213379|
Recruitment Status : Unknown
Verified July 2017 by Orkyn'.
Recruitment status was: Not yet recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Actimetry measures||Not Applicable|
The two groups are:
Referent group with one actimetric report at baseline Actimetry group with one actimetric report at baseline and during the follow-up. Using these reports the investigator will be able to modify the prescription of the apomorphin pump without seeing the patient.
It is planned to follow the patients during 6 months of follow-up and 3 medical visits will be conducted as per the standard practice:
1 visit before the installation of the pump
1 visit after the pump installation straight after the patient comes out the hospital
1 visit at 6 months
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||A unique code is given to each patient enrolled in the study. Neither the name nor the surname of patient are mentioned.|
|Primary Purpose:||Supportive Care|
|Official Title:||Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease|
|Estimated Study Start Date :||July 2017|
|Estimated Primary Completion Date :||September 15, 2018|
|Estimated Study Completion Date :||September 15, 2018|
No Intervention: Referent group
The patient of the referent group will have 2 measures of actimetry:
A first one at baseline before the apomorphim set-up:the report will be provided to the investigator and a second one before the 6 months follow-up visit but this report will not be provided to the investigator.
Experimental: Actimetry group
The patient of the Actimetry group will have at least 4 measures of actimetry and the reports will be all provided to the investigator:
One at baseline before the apomorphim set-up/ the second one 8 days after the hospitalisation/ the third one 28 days after the hospitalisation and the last one before the 6 months follow-up visit One optional measure can be performed 84 days after the hospitalisation.
Device: Actimetry measures
The patient will wear actigraphy bracelet during a week that will enable to record patients' movements. The report based on the recording will provide an assessment of daytime somnolence and an indication of propensity for impulsive behaviours.The intervention consisted in 2 supplementary actimetry measures and sending of the actimetry reports to the investigator.
- Assessment of the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump [ Time Frame: 6 months ]Proportion of patients with an unscheduled healthcare use during the first 6 months of treatment with the pump (after hospitalization for initiation) including: All medical visits to the neurologist due to the Parkinson disease New hospitalization related to the Parkinson disease