Proactive health care pathway for Parkinson's patients starting apomorphine infusion
Development of a Proactive Health Care Pathway When Initiating Continuous Subcutaneous Apomorphine Infusion in Patients With Parkinson Disease : Impact on Their Autonomy
This study is testing a new care program to see if it helps people with advanced Parkinson's disease feel more in control when starting a specific treatment with apomorphine infusion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT05405998 on ClinicalTrials.gov |
What this trial studies
This study evaluates a proactive care pathway designed to enhance patient autonomy during the initiation of continuous subcutaneous apomorphine infusion in individuals with advanced Parkinson's disease. The program combines therapeutic education, modifications to hospital procedures, and improved coordination between hospital and community care. The primary goal is to assess the impact of this pathway on patient autonomy after six months, while also measuring various clinical and economic outcomes. The study aims to empower patients and their caregivers to manage treatment more effectively.
Who should consider this trial
Good fit: Ideal candidates are adults with Parkinson's disease experiencing disabling motor fluctuations who are eligible for apomorphine pump therapy and can manage their treatment independently.
Not a fit: Patients with significant cognitive impairment or those who have previously used an apomorphine pump may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the autonomy and quality of life for patients with Parkinson's disease undergoing apomorphine therapy.
How similar studies have performed: While similar proactive care pathways have shown promise in other contexts, this specific approach to apomorphine infusion in Parkinson's disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient of legal age; * Affiliated to the social security; * Parkinson's disease according to the diagnostic criteria of the UK Parkinson's disease society brain bank clinical diagnostic criteria; * Presence of disabling motor fluctuations and/or dyskinesia despite optimized oral treatment (MDS-UPDRS IV item \>2) * Patient eligible for and accepting apomorphine pump therapy * Autonomous patient (Hoehn and Yahr stage \< 4); * No significant cognitive impairment (MoCA \>= 25) * Patient can be autonomous on the daily management of the pump according to the investigator's opinion. * Patient having signed an informed consent Exclusion Criteria: * Significant cognitive impairment (MoCA score \<25); * Major depressive episode, uncontrolled at the time of assessment (BDI\>25) or bipolar disorder; * Active visual hallucinations or history of severe hallucination episodes; * Previous apomorphine pump use; * History of respiratory distress; * History of severe impulse control disorders; * Patient and/or caregiver who cannot be empowered in the opinion of the investigator. * Protected persons, curators, persons under court protection, persons deprived of liberty by judicial or administrative decision, persons under forced psychiatric care and persons admitted to a health or social institution for purposes other than those of the research
Where this trial is running
Marseille
- Ap-Hm — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Guillaume HACHE
- Email: guillaume.hache@ap-hm.fr
- Phone: (0)4 91 38 43 98
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.