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ES-Park: Parkinson Specialized Teams Intervention
ES-Park: Evaluation of the Effectiveness of the Parkinson Specialized Teams Intervention
Overview
ES-Park: Evaluation of the Effectiveness of the Parkinson Specialized Teams Intervention
Overview
ES-Park (Evaluation de l'Effectivité des Équipes Spécialisées Parkinson) is a pilot interventional study evaluating whether a multidisciplinary specialized Parkinson's team (Équipe Spécialisée Parkinson, ESPark) can improve quality of life for patients with moderate to severe Parkinson's disease through home-based rehabilitation and support["@ctgov"].
The trial is modeled on the successful French Équipes Spécialisées Alzheimer (ESA) model, which demonstrated positive outcomes for autonomy and resocialization in Alzheimer's disease. ES-Park adapts this multidisciplinary team approach specifically for Parkinson's disease patients, recognizing that the complexity of PD — spanning motor symptoms, non-motor features, psychosocial challenges, and caregiver burden — requires coordinated care beyond standard medical management.
Trial Details
| Parameter | Details |
|-----------|--------|
| Phase | Not Applicable (Pilot/Health Services Research) |
| NCT Number | NCT05433441 |
| Status | Recruiting |
| Sponsor | University Hospital, Bordeaux |
| Study Design | Randomized, crossover, open-label |
| Allocation | Randomized |
| Intervention Model | Crossover (standard care vs ESPark) |
| Masking | None (open-label) |
| Enrollment | 250 estimated |
| Start Date | December 6, 2022 |
| Primary Completion | December 6, 2025 |
| Study Completion | June 6, 2027 |
| Study ID | CHUBX 2022/02 |
Intervention Description
The ESPark Intervention is a 15-session home-based multidisciplinary program delivered once per week by a specialized Parkinson's team. Each session is tailored to the individual patient following an initial assessment.
ESPark Team Components
The ESPark team provides:
- Functional rehabilitation: Exercises and strategies to maintain activities of daily living and mobility
- Environmental optimization: Assessment and adaptation of the patient's living environment to maximize safety and independence
- Care coordination: Integration with medical care and implementation of necessary assistive aids
- Caregiver support: Training and support for the primary non-professional caregiver
- Social reintegration: Strategies to maintain social connections and community participation
Session Structure
Study Arms
| Arm | Type | Description |
|-----|------|-------------|
| Standard Care | No Intervention | Patients continue receiving routine medical and paramedical care |
| ESPark Intervention | Experimental | 15-session home-based multidisciplinary team program in addition to standard care |
Primary Endpoints
Quality of Life (PDQ-39)
- Measure: Parkinson's Disease Questionnaire-39 (PDQ-39)
- Timepoints: Baseline (Day 0), 6 months
- Scoring: 39 items across 8 dimensions (activities of daily living, emotional well-being, stigma, social support, cognition, communication, bodily discomfort, mobility). Total score ranges from 0 (no disturbance) to 156 (maximum disturbance). Lower scores indicate better quality of life.
Secondary Endpoints
Functional Independence
| Measure | Description | Timepoints |
|---------|-------------|------------|
| IADL | Instrumental Activities of Daily Living scale (9 items, score 0-36) | Day 0, 6 months, 12 months |
Motor Assessment
| Measure | Description | Timepoints |
|---------|-------------|------------|
| MDS-UPDRS Part III | Motor examination subscale — speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination, toe tapping, leg agility, chair rise, gait, postural stability, posture, tremor (rest/action/amplitude/constancy), dyskinesia assessment, Hoehn & Yahr staging | Day 0, 6 months, 12 months |
Non-Motor Symptoms
| Measure | Description | Timepoints |
|---------|-------------|------------|
| NMSS | Non-Motor Symptoms Scale for Parkinson's Disease (30 items, 9 dimensions) | Day 0, 6 months, 12 months |
Cognitive Assessment
| Measure | Description | Timepoints |
|---------|-------------|------------|
| MoCA | Montreal Cognitive Assessment (30-point scale; 27-30: normal, 18-26: mild cognitive impairment, 10-17: moderate, <10: severe) | Day 0, 6 months, 12 months |
Psychological Outcomes
| Measure | Description | Timepoints |
|---------|-------------|------------|
| BDI-II | Beck Depression Inventory — 21 items, somatic/affective/cognitive symptoms, past 7 days, 0-63 scale (higher = more severe) | Day 0, 6 months |
Caregiver Outcomes
| Measure | Description | Timepoints |
|---------|-------------|------------|
| PQoL Carers | Parkinson's Disease Quality of Life Questionnaire for Caregivers — 26 items, total score 0-104 | Day 0, 6 months, 12 months |
| SCQ | Sense of Competence Questionnaire — 35 items across 3 domains (caregiving impact, performance satisfaction, care recipient satisfaction), scored 1-3 (27-81 scale) | Day 0, 6 months, 12 months |
Health Economics
| Measure | Description | Timepoints |
|---------|-------------|------------|
| RUD | Resource Utilization in Dementia — evaluates formal resources (social services, home care) and informal resources (caregiver time), valued at health insurance rates | Day 0, 6 months, 12 months |
Eligibility Criteria
Inclusion Criteria
Patient:
- Diagnosis of idiopathic Parkinson's disease
- Age 18 years or older
- Hoehn and Yahr Stage ≥ 3 (moderate to severe disease)
- MoCA score ≥ 21 (no major cognitive impairment)
- Living at home
- Has an identified non-professional primary caregiver
- Affiliated with or benefiting from a social security plan
- Written informed consent
- Age 18 years or older
- Able to respond to research interviews/questionnaires
- Written informed consent
Exclusion Criteria
Patient:
- Medically indicated dementia impairing comprehension and adherence, or severe confusion/psycho-hallucinatory state
- Institutionalized or in foster care
- Known severe and unstable general pathology preventing follow-up
- Currently enrolled in another non-drug management trial
- Institutionalization or change of residence planned within 6 months
- Under guardianship or unable to express consent
- Primary caregiver unwilling or unavailable for study follow-up
- Primary caregiver with known severe/unstable disease or cognitive/psychiatric disorder preventing study participation
- Pregnant or breastfeeding
- Unable to follow research interviews/questionnaires
- Unwilling or unavailable for planned follow-up
- Known severe/unstable illness or cognitive/psychiatric disorder preventing proper study conduct
Study Sites
| Site | City | Status | Contact |
|------|------|--------|---------|
| Hôpital Pellegrin (CHU de Bordeaux) | Bordeaux | Recruiting | Dr. Alexandra Foubert-Samier |
| CHU de Lille | Lille | Recruiting | Dr. Nicolas Carriere |
| CHU de Limoges | Limoges | Recruiting | Pr. Jean-Luc Houeto |
| CHU Poitiers | Poitiers | Recruiting | Dr. Isabelle Benatru |
Principal Investigator
Dr. Alexandra Foubert-Samier
University Hospital, Bordeaux
Relevance to Parkinson's Disease Care
The Case for Multidisciplinary PD Teams
Parkinson's disease is a complex multifactorial disorder requiring coordinated care across multiple domains:
- Motor symptoms: Tremor, bradykinesia, rigidity, postural instability
- Non-motor symptoms: Depression, anxiety, cognitive impairment, sleep disorders, autonomic dysfunction, pain
- Functional decline: Progressive loss of activities of daily living and social participation
- Caregiver burden: High stress and reduced quality of life among caregivers
Standard care often addresses these domains in fragmented ways — neurology visits for medication adjustment, physiotherapy for mobility, psychiatry separately for mood, with limited coordination. The ESPark model seeks to integrate these elements through a single specialized team working in the patient's home environment.
Comparison to ESA (Équipes Spécialisées Alzheimer)
The ESPark model directly adapts the French ESA framework that demonstrated positive outcomes in Alzheimer's disease. The ESA teams showed improvements in:
- Patient autonomy and functional independence
- Caregiver quality of life and sense of competence
- Reduced institutionalization rates
- Better coordination of care
ES-Park tests whether these benefits extend to PD, where the symptom profile (prominent motor disability, levodopa-induced fluctuations, distinct non-motor features) differs from Alzheimer's disease.
Home-Based Ecological Approach
The home-based delivery is a key feature of the ESPark intervention:
- Ecological validity: Rehabilitation occurs in the patient's actual living environment
- Personalization: Interventions can be directly tailored to actual daily life challenges
- Environmental modification: The team can identify and implement home adaptations
- Caregiver integration: Training occurs where care is actually delivered
Scientific Context
Health Services Research in PD
ES-Park falls within health services research — evaluating not a drug or device, but a care delivery model. This type of trial addresses:
- Effectiveness (real-world outcomes) vs. efficacy (controlled trial outcomes)
- Cost-effectiveness and resource utilization
- Patient and caregiver-reported outcomes
- Implementation science
Methodological Considerations
The crossover design allows each patient to serve as their own control, which can:
- Reduce confounding from between-patient variability
- Require smaller sample sizes for equivalent statistical power
- But: may be affected by carryover effects if the intervention period is long
The open-label design is appropriate for a behavioral/care delivery intervention where blinding participants and providers is not feasible.
Cross-References
Related Clinical Trials
- [Parkinson's Disease Overview](/clinical-trials/parkinsons-disease) — broader PD trial landscape](/proteins/parkin)
- [Exenatide Parkinson's Trial](/clinical-trials/exenatide-parkinsons) — GLP-1RA disease modification](/proteins/parkin)
- [Buntanetap Phase 3 PD](/clinical-trials/buntanetap-phase3-pd-nct07284784) — alpha-synuclein aggregation inhibition
Related Conditions
- [Parkinson's Disease](/diseases/parkinsons-disease) — disease mechanism pages](/proteins/parkin)
- [Parkinson's Disease Non-Motor Symptoms](/diseases/parkinsons-disease) — non-motor features
Related Care Approaches
- Multidisciplinary Care in Neurodegenerative Disease
- Physical Therapy in Parkinson's Disease
- Caregiver Support in Parkinson's Disease
References
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