Evaluation of a New Communication Aid Tool to Favor Global Patient Centered Care

Официальное название

Optimizing PD Patient's Health Pathways: Favoring Global, Patient Centered Care by a New Communication Aid Tool PARKINSUN

Обзор

PARKINSUN is a new communication aid tool, expected to favor global patient centered care for PD patients during consultation with GPs and neurologists. Two groups of patients will be randomized to use or not PARKINSUN when they consult their physicians every 3 months during 7 months.

Вмешательства

• Другое Consulting with PARKINSUN as communication aid-tool
  Participating patients visit their general practitioner or neurologist with PARKINSUN at 1 months, 4 months, 7 months
• Другое Consulting without PARKINSUN as communication aid-tool
  Participating patients visit their general practitioner or neurologist without PARKINSUN at 1 months, 4 months, 7 months

Первичные конечные точки

• variation of the delta of G-MISS Questionnaire [Срок оценки: at 7 months]

Вторичные конечные точки (7)

• G-MISS-Questionnaire at the end of each consultation (1 month, 4 months and 7 months) [Срок оценки: at the end of each consultation (1 month and 7 months)]
• Global score of PARKINSUN [Срок оценки: at the end of each consultation ((1 month and 7 months)]
• Individuals scores of PARKINSUN [Срок оценки: at the end of each consultation ((1 month and 7 months)]
• MDS-UPDRS scores [Срок оценки: at the end of each consultation ((1 month and 7 months)]
• PDQ-39 scores 6. Interpersonal Reactivity Index (IRI) [Срок оценки: at the end of each consultation ((1 month and 7 months)]
• Likert Scale [Срок оценки: at the end of each consultation (1 month and 7 months)]
• Interpersonal Reactivity Index (IRI) [Срок оценки: at the end of each consultation (1 month and 7 months)]

Критерии участия

Критерии включения

• Adult men and women with all stages of PD
• Without severe chronic neurological or mental or psychiatric pathology
• Absence of cognitive impairment affecting autonomy (MDS criteria of dementia and MOCA > 22)
• able to come (alone or accompanied) to consultation
• Affiliate or beneficiary of a social security scheme
• Subject having signed informed consent
• Patient willing to comply with all procedures of the study and its duration

Критерии исключения

• Administrative reasons: impossibility of receiving informed information, inability to participate in the whole study, absence of coverage by the social security system, refusal to sign consent.
• Subject under tutelage or curtailer.
• Subject not fluent in the French language to understand the instructions necessary to carry out the cognitive tests.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• Hopital Roger Salengro, CHU Lille — Lille

Идентификаторы

NCT: NCT04179695 · 2018_74 · 2019-A01008-49

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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