Evaluating a specialized team approach for Parkinson's patients at home

Evaluation of the Effectiveness of the Parkinson's Specialized Teams Intervention on the Quality of Life of Parkinson's Patients in the Territory of the Nouvelle-Aquitaine and Hauts-de-France: ES-Park Pilot Study.

This study is testing a new team approach to help people with moderate to severe Parkinson's disease living at home to see if it can improve their daily life and well-being.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Bordeaux (Academic / other)
• Locations: 4 sites (Bordeaux and 3 other locations)
• Trial ID: NCT05433441 on ClinicalTrials.gov

What this trial studies

This pilot interventional study aims to establish a multidisciplinary team, known as ESPark, to support patients with moderate to severe Parkinson's disease living at home. The study will assess the effectiveness of this specialized intervention on the quality of life of these patients. By addressing the diverse and complex needs of Parkinson's patients and their caregivers, the ESPark team seeks to improve daily living activities and overall well-being. The approach is inspired by positive outcomes from similar interventions in Alzheimer's care.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a diagnosis of idiopathic Parkinson's disease at Hoehn and Yahr Stage 3 or higher, living at home with a primary caregiver.

Not a fit: Patients with major cognitive impairments or severe confusion may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance the quality of life for patients with Parkinson's disease.

How similar studies have performed: Previous studies have shown mixed results for similar multidisciplinary approaches, but there is evidence of positive outcomes in Alzheimer's care that may support this intervention's potential.

Eligibility criteria

Inclusion Criteria:

For the patient:

* Patient with a diagnosis of idiopathic Parkinson's disease
* Patient over 18 years ;
* Patient with a Hoehn and Yahr Stage greater than or equal to 3;
* Patient without major cognitive impairment defined by a MOCA score ≥21
* Patient living at home ;
* Patient with an identified non-professional primary caregiver;
* Person affiliated with or benefiting from a social security plan;
* Free, informed and and express consent (confirmed in writing) (no later than the day of inclusion and before any examination required by the research).

For the caregiver:

* Male or female over 18 years
* Able to respond to research interviews/questionnaires
* Free, informed and express consent (confirmed in writing) (no later than the day of inclusion and before any examination required by the research).

Exclusion Criteria:

For the patient:

* Patient with medically indicated dementia impairing comprehension and adherence, and/or with severe confusion or psycho-hallucinatory state;
* Institutionalized or foster care patients;
* Patients with a known severe and unstable general pathology that does not allow for patient follow-up;
* Patients already included in another non-drug management trial;
* Patients whose institutionalization is envisaged in the short term (within 6 months) or for whom a change of residence is envisaged in the short term and would not allow for follow-up assessments;
* Patients under guardianship or unable to express consent
* Primary caregiver not wishing to participate in the study or unable to be available for the planned study follow-up;
* Presence of a primary caregiver with a known severe and unstable disease that does not allow for the conduct of the study;
* Presence of a primary caregiver with a known cognitive or psychiatric disorder (chronic progressive psychosis) that does not allow for the proper conduct of the study.
* Pregnant or breastfeeding woman.

For the caregiver:

* Unable to follow the research interviews or questionnaires.
* Primary caregiver not wishing to participate in the study or unable to be available for the planned study follow-up;
* Primary caregiver with a known severe and unstable illness that does not allow for the proper conduct of the study;
* Primary caregiver with known cognitive or psychiatric disorders (chronic progressive psychosis) that do not allow the study to be conducted properly.

Where this trial is running

Bordeaux and 3 other locations

• Hopital Pellegrin — Bordeaux, France (Recruiting)
• CHU de Lille — Lille, France (Recruiting)
• CHU de Limoges — Limoges, France (Recruiting)
• CHU Poitiers — Poitiers, France (Recruiting)

Study contacts

• Principal investigator: Alexandra FOUBERT-SAMIER — University Hospital, Bordeaux
• Study coordinator: Alexandra FOUBERT-SAMIER, Dr

Conditions Parkinson Disease; Parkinson; Quality of life; Complementary non drug intervention; Multidisciplinary approach