Clinical trial NCT05433441: Evaluation of the Effectiveness of the Parkinson Specialized Teams Intervention
Official title: 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: ES-Park Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
Quality of life
Complementary non drug intervention
Multidisciplinary approach
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Parkinson's disease (PD) and related disorders are the second most common cause of motor disability in the elderly after stroke. Progressively, the disability impacts the activities of daily living and social life of Parkinson's patients with a major impact on their quality of life. The diversity and complexity of the needs of parkinsonian patients and their caregivers justify a specific multidisciplinary approach. Several studies have evaluated the effectiveness of the intervention of such teams on the maintenance of activities of daily living and quality of life of Parkinson's patients with contradictory results. In France, the experience of specialized Alzheimer teams (ESA) based on the same concept seems to have brought positive results on autonomy and resocialization. Based on the positive experience of ESA intervention in Alzheimer's disease and in view of the data in the literature on Parkinson's disease, we would like to develop the same type of care with teams adapted to the problems of Parkinson's disease patients, which we could call ESParks, and to evaluate the effectiveness of such teams in the context of support for Parkinson's patients.

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.

Primary outcomes:
measure: Score of quality of life scale (PDQ 39)
timeFrame: Initial Visit - Day 0
measure: Score of quality of life scale (PDQ 39)
timeFrame: 6 months
Secondary outcomes:
measure: IADL assessment
timeFrame: Initial Visit - Day 0
measure: IADL assessment
timeFrame: 6 months
measure: IADL assessment
timeFrame: 12 months
measure: Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
timeFrame: Initial Visit - Day 0
measure: Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
timeFrame: 6 months
measure: Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
timeFrame: 12 months
measure: Non-motor symptoms Scale for Parkinson's Disease (NMSS)
timeFrame: Initial Visit - Day 0
measure: Non-motor symptoms Scale for Parkinson's Disease (NMSS)
timeFrame: 6 months
measure: Non-motor symptoms Scale for Parkinson's Disease (NMSS) score
timeFrame: 12 months
measure: Montreal Cognitive Assessment (MOCA) score
timeFrame: Initial Visit - Day 0
measure: Montreal Cognitive Assessment (MOCA) score
timeFrame: 6 months
measure: Montreal Cognitive Assessment (MOCA) score
timeFrame: 12 months
measure: Beck Depression Inventory (BDI-II) score
timeFrame: Initial Visit - Day 0
measure: Beck Depression Inventory (BDI-II) score
timeFrame: 6 months
measure: Beck Depression Inventory (BDI-II) score
timeFrame: 12 months
measure: Parkinson Anxiety Scale (PAS) Score
timeFrame: Initial Visit - Day 0
measure: Parkinson Anxiety Scale (PAS) Score
timeFrame: 6 months
measure: Parkinson Anxiety Scale (PAS) Score
timeFrame: 12 months
measure: Reduced Neuropsychiatric Inventory (NPI-R) score
timeFrame: Initial Visit - Day 0
measure: Reduced Neuropsychiatric Inventory (NPI-R) score
timeFrame: 6 months
measure: Reduced Neuropsychiatric Inventory (NPI-R) score
timeFrame: 12 months
measure: Zarit scale score
timeFrame: Initial Visit - Day 0
measure: Zarit scale score
timeFrame: 6 Months
measure: Zarit scale score
timeFrame: 12 Months
measure: State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
timeFrame: Initial Visit - Day 0
measure: State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
timeFrame: 6 months
measure: State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
timeFrame: 12 months
measure: Quality of life as measured by the PQoL Carers.
timeFrame: Initial Visit - Day 0
measure: Quality of life as measured by the PQoL Carers.
timeFrame: 6 months
measure: Quality of life as measured by the PQoL Carers.
timeFrame: 12 months
measure: Sense of competence questionnaire
timeFrame: Initial Visit - Day 0
measure: Sense of competence questionnaire
timeFrame: 6 months
measure: Sense of competence questionnaire
timeFrame: 12 months
measure: Ressource Utilization in Dementia (RUD)
timeFrame: Initial Visit - Day 0
measure: Ressource Utilization in Dementia (RUD)
timeFrame: 6 Months
measure: Ressource Utilization in Dementia (RUD)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Limoges
country: France
facility: CHU de Limoges
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
affiliation: University Hospital, Bordeaux
name: Alexandra FOUBERT-SAMIER
role: PRINCIPAL_INVESTIGATOR
References: