Parkinsonian Patients Treated With Apomorphine Pump: Observatory of Skin Lesions
NCT ID: NCT05331573
Last Updated: 2022-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
108 participants
OBSERVATIONAL
2020-10-01
2024-10-01
Brief Summary
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The procedures outside of the patient's usual care are only more in-depth clinical assessments and examinations (interviews with a nurse, skin lesion assessment scale, quality of life scales, neurological and cognitive assessment scales).
At each visit, the patient will be seen in consultation by a state-qualified nurse from the neurology department who will conduct
* nursing interviews to assess tolerance and compliance with treatment. She will also look for data concerning the flow rate, the duration of the subcutaneous apomorphine pump and the injection methods (material used, rotation of injection sites, massages).
* collection of adverse effects and changes in concomitant treatments.
* assessment of skin complications (number, location, characteristics: size, pain, inflammation).
For centres that do not have a nurse dedicated to monitoring these patients, the above procedure will be carried out by the neurologist.
In all cases, the patient will receive a consultation (in the department or remotely) by the neurologist.
The tests and scales performed at inclusion will be repeated at each six-monthly visit.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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apomorphine pump
observationnal
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Parkinson's disease according to the MDS criteria (2015),
* Patients with a prescription for subcutaneous apomorphine pump therapy,
* Patient having read and understood the information letter and having expressed oral non-opposition to the research.
Exclusion Criteria
* Patient not affiliated to the social security system,
* Pregnant woman or woman in labour or breastfeeding,
* Person deprived of liberty by an administrative or judicial decision,
* Person placed under court protection, guardianship or curatorship.
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Locations
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CHU Amien
Amiens, , France
CHU Caen
Caen, , France
CH de Dreux
Dreux, , France
CHRU Lille
Lille, , France
Hôpital St Vincent de Paul
Lille, , France
Chu Rouen
Rouen, , France
Clinique Saint Hilaire
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019/069/OB
Identifier Type: -
Identifier Source: org_study_id
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