Patients With Parkinson's Disease Treated With Apomorphine Pumps
Conditions
Brief summary
Treatment with subcutaneous apomorphine will be initiated according to the usual procedures at each centre. Once the patient is included in the study, he/she will be followed for 24 months according to a schedule of visits corresponding to his/her follow-up care. 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.
Interventions
DEVICEapomorphine pump
observationnal
Sponsors
University Hospital, Rouen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years, * 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 unable to express opposition or non-opposition, * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the occurrence of at least one painful | up to 24 weeks | pain rating scale ≥ 1/10 |
| the occurence of treatment discontinuation | up to 24 weeks | skin nodule any size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale | six-monthly visit | — |
| Hoehn and Yahr | six-monthly visit | — |
| Assessment of nodules | at stopping apomorphine | number, localisation |
| Test of Montreal Cognitive Assessment | six-monthly visit | — |
| Parkinson's Disease Questionnaire : quality of life scale, | six-monthly visit | — |
| assessment of the pain of nodules or erythema | up to 24 weeks | Visual Analogue Scale from 1 to 10: |
Countries
France
Contacts
Primary ContactLinda VERNON, nurse
Outcome results
None listed