Interest of Continuous Subcutaneous Apomorphine in Parkinsonian Patients at the End of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Rigidity
研究概览
简要总结
Care for Parkinson's patients at the end of life is far from optimal, particularly due to specificities linked to the disease itself, often unknown to non-specialists.
A study carried out at the CHU Rennes on data covering the period 2006-2018 showed that only 132 patients died in this hospital, two-thirds of whom came from home. In 42% of cases, antiparkinsonian treatment was stopped before death without specialist advice (palliative or neurological), with the corollary of the appearance of a dopaminergic withdrawal syndrome (or pseudo-neuroleptic malignant syndrome) in a high proportion of these patients. Neuroleptic pseudo-malignant syndrome is a major cause of discomfort. If left untreated, it can precipitate death in particularly distressing conditions for the patient, his or her family and caregivers.
The Rennes study also suggests that Parkinson's patients rarely die in hospital. In fact, work carried out by FNEHAD on data for 2022 showed that 1,800 Parkinson's patients were cared for in HAH in France during that same year, mainly for palliative care or heavy nursing reasons. Half of these patients died.
End-of-life management of Parkinson's disease therefore requires local clinical and pharmacological expertise. A recent observational study suggests that the use of a subcutaneous apomorphine pump brings substantial benefits in terms of clinical comfort, both motor and non-motor, as well as relief for family and friends, easier nursing care for the nursing team, and in some cases, renewed communication.
Such care can be provided in the home, and must necessarily be multidisciplinary, combining palliative expertise, provided by Home Hospitalization (HH) teams, with technical and Parkinson's expertise, provided by Home Healthcare Providers (HHPs) experienced in managing the apomorphine pump, in liaison with the referral team.
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
- •Person (or trusted person/relative if patient is unable) who has agreed to participate in the study
- •Patient of legal age
- •Advanced Parkinson's disease with apomorphine pump indication
- •Use of HH for palliative reasons
- •Loss of orality (discontinuation of oral treatments)
- •Hoehn &Yahr score in OFF = 5 (bilateral and axial symptoms in the absence of levodopa)
排除标准
- •Apomorphine pump already in use
- •Opposition to the introduction of an apomorphine pump
- •Protected person (under guardianship or curatorship)
- •Person under court protection
- •Persons deprived of liberty
- •Persons not affiliated to a social security scheme
- •Pregnant or breast-feeding woman
结局指标
主要结局
Rigidity
时间窗: Day 6
measured by the specific sub-section of rigidity of the internationally recognized UPDRS 3 scale validated in French. This criterion will be assessed before the apomorphine pump is installed and 6 days afterwards. The 5 items are scored from 0 to 4, so the total score ranges from 0 to 20.
Rigidity
时间窗: Day 0
measured by the specific sub-section of rigidity of the internationally recognized UPDRS 3 scale validated in French. This criterion will be assessed before the apomorphine pump is installed and 6 days afterwards. The 5 items are scored from 0 to 4, so the total score ranges from 0 to 20.
次要结局
- Change in analgesic consumption(Day 45)
- Proportion of hypotension(Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45)
- Proportion of skin condition related to apomorphine(Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45)
- Change in alertness and agitation levels(Day 45)
- Change in communication with the care team and relatives(Day 45)
- Change in nursing care(Day 45)
- Change in caregiver burden(Day 0, 2, 6, 18, 30 and Day 45)
- Proportion of nausea/vomiting(Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45)
- Proportion of hallucinations(Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45)