Parkinson Disease
Conditions
Keywords
actimeter, apomorphin pump
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
Interventions
DEVICEActimetry 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.
Sponsors
Orkyn'
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
A unique code is given to each patient enrolled in the study. Neither the name nor the surname of patient are mentioned.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump | 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 |
Outcome results
None listed