NCT06080126

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

October 17, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

September 21, 2023

Last Update Submit

October 13, 2023

Conditions

Keywords

Meaningful activities facilitatorsgeriatric service

Outcome Measures

Primary Outcomes (1)

  • Feasibility and acceptability of implementing meaningful activities facilitators (MAF) in a French short stay geriatric unit, from the perspective of professionals, MAF and patients/relatives.

    Criteria to conclude on feasibility will be the fulfilment of the following criteria during the intervention period (MAF implementation): * employment of two MAFs (one per participating unit, 0.5FTE), * SATIN and EEPMT Questionnaire

    From the implementation of a meaningful activities facilitators for a period of 4 months.

Study Arms (2)

Control

OTHER
Other: Control: per usual practice

Intervention

OTHER
Other: Intervention MAF

Interventions

160 patients were included as per usual practice.

Control

160 patients were included with MAF intervention.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient aged 65 and over
  • admitted to a geriatric short-stay hospital for \> 72 hours
  • Considered "at risk of complications related to hospitalisation": at least two of the following criteria:
  • Clinical Frailty Scale (Rockwood Clinical Frailty Score
  • At least one ADL-IADL dependency,
  • Presence of known cognitive impairment,
  • Patient confused on admission,
  • History of confusional syndrome on previous hospitalisation or use of medication,
  • Anxiety-depression (history or current pathology),
  • Repeated falls (\>2 in a year) or fear of falling,
  • Risk of sarcopenia (Score \>4 on the SARC-F questionnaire
  • Presenting undernutrition or a risk of undernutrition (according to medical assessment, e.g. low BMI, anorexia, recent weight loss).
  • Patient having been informed of the study and having signed an informed consent (for patients under guardianship, the consent of the guardian will be requested). For patients under guardianship, the patient will sign the consent in the presence of the guardian.
  • Patient who understands and speaks French
  • Patient affiliated to a social security scheme

You may not qualify if:

  • Patient in palliative care for a terminal disease
  • Re-hospitalised patients already included during a previous stay
  • Patients under court protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Geriatric Short Stay Department - Unit 3C of the Charpennes Hospital

Lyon, 69100, France

Location

University Department of Geriatric Medicine, Centre Hospitalier Lyon Sud

Lyon, 69495, France

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study will be conducted in a 2-phase approach corresponding to the 2 successive phases of the MRC guidance: * Phase 1: The adaptation of the intervention to our context will be based on a literature review and a qualitative study. * Phase 2: The feasibility and acceptability of the intervention will be assessed during a quasi-experimental before and after study conducted in two short-stay geriatric units.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

October 12, 2023

Study Start

October 30, 2023

Primary Completion

December 31, 2024

Study Completion

April 30, 2025

Last Updated

October 17, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations