Impact of Implementing the Personalized Non-Pharmacological Therapies Method in Facilities for the Elderly (IMPACT-TNmP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Personalized Non-pharmacological Therapies
• Intervention / Treatment: Other: TNmP

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 226
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie BRENIERE, Dr; Phone Number: 01 81 70 51 97; Email: valerie.breniere@univi.fr
• Study Contact Backup: Name: Fatima IZEDAREN; Phone Number: 0139637451; Email: fatima-zohra.izedaren@lpv.univi.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: before/after study; 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).	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity or frequency of behavioral disorders	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	At inclusion and 6 months after inclusion

Collaborators and Investigators

• Sponsor: Centre Médical Porte Verte

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2026
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): April 5, 2027

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-A02736-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No