Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to compare the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump. To do so, the study design includes a patients' randomisation in two groups that will be followed during 6 months.

Detailed Description
-----------------
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

Official Title
-----------------
Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: Actimetry measures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult suffering from Parkinson's disease aged up to 75 years (included) Patient for whom a first set-up of an apomorphine pump has been decided under medical guidelines Patient who chose the OPTIPARK package (ORKYN nurses) Patient willing to wear the actigraphy bracelet as per the protocol Patient who read, understood and signed the consent form. Exclusion Criteria: Patient not willing to take part in the study Patient who had a previous set-up of an apomorphine pump Patient with dementia Dependant patients or patients living in institutional care Patient with a temporary pump of apomorphine compromising a six months follow-up Patient with non-major motor fluctuations Patient already enrolled in an interventional study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Referent group<br>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<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump | 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 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
actimeter, apomorphin pump