Impact of Implementing the Personalized Non-Pharmacological Therapies Method in Facilities for the Elderly

Официальное название

Impact of Implementing the Personalized Non-Pharmacological Therapies Method in Facilities for the Elderly - A Multicenter Comparative Study

Обзор

To evaluate, by comparison with the classical method, the effectiveness of using the TNmP method in reducing the intensity or frequency of behavioral disorders in elderly people institutionalized in an institution.

Подробное описание

Cognitive and psychological symptoms (CPS) are highly prevalent among dependent individuals with residual cognitive decline living in nursing homes (EHPAD). It is well established that personalized non-pharmacological therapies (PNPTs) play a major role in the management of CPS.

Traditionally, PNPTs are selected by geriatric nursing assistants according to the type of CPS and their knowledge of the resident, and are implemented in real time. The present project aims to describe and characterize a novel approach to the selection of PNPTs: the TNmP method, developed by Dr. Thierry Bautrant.

The TNmP method is based on an in-depth observation of behavioral disturbances and on a multidisciplinary decision-making process, with the objective of ensuring that the proposed PNPT is optimally adapted to the underlying psychiatric condition (anxiety, depression, apathy, or psychotic disorders) responsible for the behavioral symptoms. This approach takes into account the individual's life history and personality, personal preferences, and preserved physical and cognitive abilities (referred to as CHA: capacities, history, affinities).

To this end, healthcare professionals, under the supervision of their clinical leadership (physician, psychologist), meet on a weekly basis to discuss residents' cases. These meetings aim to identify the observed symptoms, determine their underlying causes, integrate the CHA framework, and select the most appropriate therapeutic intervention, including its practical modalities of implementation (who delivers the intervention, when, and how).

Вмешательства

• Другое TNmP
  To evaluate the effectiveness of the TNmP method in reducing the intensity and/or frequency of behavioral disturbances by comparing two groups of centers (four using the conventional PNPT selection method and six using the TNmP method).

Первичные конечные точки

• Intensity or frequency of behavioral disorders [Срок оценки: At inclusion and 6 months after inclusion]

Критерии участия

Критерии включения

• Individuals aged 65 years and older;
• Dependent older adults residing in institutional settings, including individuals under legal guardianship or trusteeship, who have been recently admitted to the facility;
• Individuals presenting a neurocognitive disorder associated with disruptive cognitive and psychological symptoms (CPS), such as agitation, oppositional behavior, or excessive wandering;
• Free and informed consent to participate in the study, signed by the participant or their legal representative.

Критерии исключения

• Lack of affiliation to a health insurance or social security scheme;
• Life expectancy of less than three months;
• Inability to obtain a signed informed consent form from the resident or their legal representative

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07430241 · 2025-A02736-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗