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Идёт набор NCT07257861

Interest of Continuous Subcutaneous Apomorphine in Parkinsonian Patients at the End of Life

— Наблюдательное Parkinson Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Questionnaires.
Кому может быть актуально
Состояния в реестре: Parkinson Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Другое Questionnaires
    Parkinsonian patients in HH will receive an apomorphine pump as part of their routine care. Questionnaires will be completed at D0, D2, D4, D6, D12, D18, D24, D30 and D45. The questionnaires used will be * UPDSR III: stiffness * Algoplus * Richmond Scale (RASS) * Likert scale Entourage before/after * Likert scale Caregivers before/after * Zarit scale

Первичные конечные точки

  • Rigidity [Срок оценки: Day 0]
  • Rigidity [Срок оценки: Day 6]
Вторичные конечные точки (9)
  • Change in analgesic consumption [Срок оценки: Day 45]
  • Change in alertness and agitation levels [Срок оценки: Day 45]
  • Change in communication with the care team and relatives [Срок оценки: Day 45]
  • Change in nursing care [Срок оценки: Day 45]
  • Change in caregiver burden [Срок оценки: Day 0, 2, 6, 18, 30 and Day 45]
  • Proportion of nausea/vomiting [Срок оценки: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45]
  • Proportion of hypotension [Срок оценки: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45]
  • Proportion of skin condition related to apomorphine [Срок оценки: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45]
  • Proportion of hallucinations [Срок оценки: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Had Crest — Crest

Идентификаторы

NCT: NCT07257861 · CHUO-2025-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗