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

NCT ID: NCT03213379

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2018-09-15

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

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Actimetry measures

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orkyn'

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Ref ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

P1530

Identifier Type: -

Identifier Source: org_study_id