Parkinsonian Patients Treated With Apomorphine Pump: Observatory of Skin Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 7
- 主要终点
- the occurrence of at least one painful
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
the occurrence of at least one painful
时间窗: up to 24 weeks
pain rating scale ≥ 1/10
the occurence of treatment discontinuation
时间窗: up to 24 weeks
skin nodule any size
次要结局
- Assessment of nodules(at stopping apomorphine)
- Parkinson's Disease Questionnaire : quality of life scale,(six-monthly visit)
- Hoehn and Yahr(six-monthly visit)
- Test of Montreal Cognitive Assessment(six-monthly visit)
- Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale(six-monthly visit)
- assessment of the pain of nodules or erythema(up to 24 weeks)