Evaluation of the Effectiveness of the Parkinson Specialized Teams Intervention

Официальное название

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.

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура ESPark Intervention
  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.

Первичные конечные точки

• Score of quality of life scale (PDQ 39) [Срок оценки: Initial Visit - Day 0]
• Score of quality of life scale (PDQ 39) [Срок оценки: 6 months]

Вторичные конечные точки (12)

• IADL assessment [Срок оценки: Initial Visit - Day 0]
• IADL assessment [Срок оценки: 6 months]
• IADL assessment [Срок оценки: 12 months]
• Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate [Срок оценки: Initial Visit - Day 0]
• Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate [Срок оценки: 6 months]
• Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate [Срок оценки: 12 months]
• Non-motor symptoms Scale for Parkinson's Disease (NMSS) [Срок оценки: Initial Visit - Day 0]
• Non-motor symptoms Scale for Parkinson's Disease (NMSS) [Срок оценки: 6 months]
• Non-motor symptoms Scale for Parkinson's Disease (NMSS) score [Срок оценки: 12 months]
• Montreal Cognitive Assessment (MOCA) score [Срок оценки: Initial Visit - Day 0]
• Montreal Cognitive Assessment (MOCA) score [Срок оценки: 6 months]
• Montreal Cognitive Assessment (MOCA) score [Срок оценки: 12 months]

Критерии участия

Критерии включения

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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 4 центра

• Hopital Pellegrin — Bordeaux
• CHU de Lille — Lille
• CHU de Limoges — Limoges
• CHU Poitiers — Poitiers

Идентификаторы

NCT: NCT05433441 · CHUBX 2022/02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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