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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional d'Orléans

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Apomorphine pump already in use

Opposition to the introduction of an apomorphine pump

Protected person (under guardianship or curatorship)

Person under court protection

Trial population

Parkinsonian patients treated in HH.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaires

    Other intervention

    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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Parkinson patients1 intervention

Trial outcomes

Primary outcomes

1

Rigidity

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.

Time frame
Day 0
2

Rigidity

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.

Time frame
Day 6

Secondary outcomes

1

Change in analgesic consumption

Change in analgesic consumption will be recorded at Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45 and will be evaluated at the end of the study

Time frame
Day 45
2

Change in alertness and agitation levels

It will be will be evaluated by the Richmond Scale, from + 4 to -4 with +4 for very combative patient and -4 for unresponsive patient.

Time frame
Day 45
3

Change in communication with the care team and relatives

It will be evaluated with the Lickert scale for care team that assesses the patient's communication ability from -3 to +3 with -3 for greatly aggravated and +3 for greatly improved

Time frame
Day 45
4

Change in nursing care

It will be evaluated with the Lickert scale for caregivers that assesses the level of quality of nursing care. from -3 to +3 with -3 for greatly aggravated and +3 for greatly improved

Time frame
Day 45

Other outcomes

Sponsors and contacts

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Centre Hospitalier Régional d'Orléans

Lead sponsor

Fédération Francaise d'Hospitalisation à Domicile (FNEHAD)

Collaborator

France Développement Electronique (FDE)

Collaborator