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Clinical Trial Summary

Older people are particularly vulnerable to adverse effects of hospitalization, which can compromise their functional autonomy. The onset of confusion, loss of mobility or malnutrition is largely related to the context of hospitalization itself, which creates stressful situations for patients in addition to the acute pathology: change in the usual living environment, lack of human and reassuring interactions, lack of mobility related to the pathology or caused by the use of barriers or restraints. These geriatric complications can be prevented. Programs involving the intervention of volunteers or dedicated professionals with hospitalized patients have been developed. These "Meaningful Activities Facilitators" (MAF) have the task of preventing or limiting the deleterious effects of hospitalization on the older people, in particular by stimulating eating and walking, and by practicing social activities in line with the patient's lifestyle habits. This system has been set up in geriatric short-stay wards in the United Kingdom, where MAFs, who received specific training, are integrated into the care team and work with patients at risk. The integration of these MAFs has shown a reduction in the incidence and duration of delirium episodes, the use of psychotropic drugs, and the use of restraint. A study currently underway in Australia aims to reduce hospital-acquired complications through a program of mobilization, nutrition, and engagement of patients in constructive activities (the "Eat, Walk, Engage" program) implemented by a trained MAFs. The investigators hypothesis is that the implementation of MAFs in geriatric short-stay wards will reduce the incidence of geriatric complications associated with hospitalization. Objectives: The investigators objective is to study the feasibility and acceptability of integrating MAFs into the care teams of two geriatric short-stay services in France. The investigators will evaluate the adaptations to be proposed to the MAF model to make it relevant in our context from the point of view of patients, their relatives and professionals, and will study the effect of this intervention on the occurrence of complications and the functioning of the teams, its implementation and its costs. Perspectives: The results of this study will allow us to define if the MAFs intervention is feasible and acceptable in the French context, and if so, to propose an intervention model adapted to our context.


Clinical Trial Description

Methods: The project will be carried out in 2 phases guided by the Medical Research Council's (MRC) recommendations for the development and evaluation of complex health interventions. Phase 1: Adaptation of the MAFs intervention to our context, combining literature review, non-participant observation, semi-structured interviews, and coconstruction workshops. Phase 2: Feasiblity testing : A quasi-experimental feasibility "before and after" study will be conducted in two geriatric short-stay services on 380 patients: "before" period over 4 months (inclusion of 160 hospitalized patients constituting the control group), recruitment and training of 2 MAFs, implementation of the intervention, "after" period over 4 months (inclusion of 160 hospitalized patients constituting the intervention group). The patients will be included at admission and followed up during the hospital stay. The data collected concern the occurrence of complications during the stay, the quality of life at work of the professionals, and in the "after" period, the acceptability and fidelity of the MAFs intervention, according to the point of view of the MAFs, the professionals and the patients/relatives. These criteria will be collected through monitoring of the MAFs activity (logbook, medical records) and semi-structured interviews. The impact of the integration of the MAFs on the functioning, team cohesion and collaboration will be studied. The results will allow us to propose phase 3 of the MRC recommendations, a multicenter randomized controlled evaluation in clusters, informed by the results for the content of the intervention, the implementation strategies, the choice of the primary endpoint, the inclusion criteria of the population, the calculation of the sample size and the study procedures (inclusion, data collection). ;


Study Design


NCT number NCT06080126
Study type Interventional
Source Hospices Civils de Lyon
Contact Thomas GILBERT, MD
Phone 4.78.86.49.39
Email thomas.gilbert@chu-lyon.fr
Status Not yet recruiting
Phase N/A
Start date October 30, 2023
Completion date April 30, 2025