NCT05433441

Brief Summary

A pilot experiment interventional study is proposed in order to set up multidisciplinary team for Parkinson's patients at home. The aim of this study is to evaluate the effectiveness of this specialized Parkinson's team (ESPark) intervention a on the quality of life of patients with moderate to severe Parkinson's disease

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
13mo left

Started Dec 2022

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Dec 2022Jun 2027

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

December 6, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2027

Expected
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

June 21, 2022

Last Update Submit

July 21, 2025

Conditions

Parkinson Disease

Keywords

ParkinsonQuality of lifeComplementary non drug interventionMultidisciplinary approach

Outcome Measures

Primary Outcomes (2)

  • Score of quality of life scale (PDQ 39)

    Self-questionnaire in 39 items evaluating the quality of life of Parkinson's patients from a motor and psychological point of view. Each question is rated from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily living, emotional well-being, psychological discomfort, social support, cognitive impairment, communication, physical discomfort, mobility) It consists of 39 items with a total score that varies from 0 to 154

    Initial Visit - Day 0

  • Score of quality of life scale (PDQ 39)

    Self-questionnaire in 39 items evaluating the quality of life of Parkinson's patients from a motor and psychological point of view. Each question is rated from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily living, emotional well-being, psychological discomfort, social support, cognitive impairment, communication, physical discomfort, mobility) It consists of 39 items with a total score that varies from 0 to 154

    6 months

Secondary Outcomes (36)

  • IADL assessment

    Initial Visit - Day 0

  • IADL assessment

    6 months

  • IADL assessment

    12 months

  • Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate

    Initial Visit - Day 0

  • Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate

    6 months

  • +31 more secondary outcomes

Study Arms (2)

Standard care

NO INTERVENTION

ESPark Intervention

EXPERIMENTAL

Under medical prescription and in addition to medical and physiotherapy care, the ESPark will intervene in an ecological way with Parkinson's patients in order to rehabilitate them, maintain their autonomy in their daily life and their social life with the aim of improving the quality of life of the patient and his main caregiver. Beyond a rehabilitative intervention in the home, the ESPark's mission would also be to optimize the patient's living environment and possibly help with the implementation of the necessary aids in the continuity of medical care.

Procedure: ESPark Intervention

Interventions

ESPark InterventionPROCEDURE

The treatment will include 15 sessions (1 session per week). An initial assessment will be carried out during the first session in order to determine the objectives and the personalized follow-up.

ESPark Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • For the caregiver:
  • Male or female over 18 years
  • Able to respond to research interviews/questionnaires

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hopital Pellegrin

Bordeaux, 33000, France

RECRUITING

CHU de Lille

Lille, 59037, France

RECRUITING

CHU de Limoges

Limoges, 87042, France

RECRUITING

CHU Poitiers

Poitiers, 90577, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Alexandra FOUBERT-SAMIER

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra FOUBERT-SAMIER, Dr

CONTACT

05 57 82 12 53alexandra.samier-foubert@u-bordeaux.fr

Sandrine DUPOUY

CONTACT

05 57 82 14 62sandrine.dupouy@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

December 6, 2022

Primary Completion

December 6, 2025

Study Completion (Estimated)

June 6, 2027

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations

FR(4)