Impact of Implementing the Personalized Non-Pharmacological Therapies Method in Facilities for the Elderly - A Multicenter Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 226
- 主要终点
- Intensity or frequency of behavioral disorders
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
before/after study
To evaluate the effectiveness of the TNmP method in reducing the intensity and/or frequency of behavioral disturbances by comparing ten groups of centers (four using the conventional PNPT selection method and six using the TNmP method).
干预措施: TNmP (Other)
结局指标
主要结局
Intensity or frequency of behavioral disorders
时间窗: At inclusion and 6 months after inclusion
The primary outcome measure is to determine whether the use of the TNmP method is associated with greater effectiveness, compared with the conventional method, in reducing the intensity and/or frequency of agitation, resistance to care, or excessive wandering
次要结局
未报告次要终点
研究者
Valérie BRENIERE
Principal Investigator
Centre Médical Porte Verte