NCT06173154

Brief Summary

To assess the feasibility of a care system to prevent iatrogenic dependency during hospitalisation in people 70 years old and over. 2 cares units participate : one with routine care and the other with a care system to prevent ID. The caregivers of this unit receive training about iatrogenic dependency and how prevent it. They set up this prevention and the research compare evolution of dependence hospitalized patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

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

December 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

June 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

December 7, 2023

Last Update Submit

December 15, 2025

Conditions

Keywords

preventionelderlydependancehospitalization

Outcome Measures

Primary Outcomes (1)

  • number of participants with loss of independence

    loss of independence is defined as a decrease of at least 0.5 points in Activities of Daily Living (ADL) scale between admission and discharge of the patient within 15 days of admission to the ward, regardless of when this event occurs during the hospitalization.

    15 days

Study Arms (2)

ID prevention unit

EXPERIMENTAL

One healthcare unit will implement the healthcare system for the prevention of iatrogenic dependency (ID) and one healthcare unit will provide standard care without any specific system in place.

Other: Care system to prevent ID

Control unit

SHAM COMPARATOR

One healthcare unit will implement the healthcare system for the prevention of iatrogenic dependency (ID) and one healthcare unit will provide standard care without any specific system in place.

Other: Routine care

Interventions

The caregivers of this unit receive training about iatrogenic dependency and how prevent it. They set up this prevention and the research compare evolution of dependence hospitalized patients.

ID prevention unit

standard care without any specific system in place

Control unit

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient hospitalized for at least 48 hours in the participating center
  • Persons affiliated to a social security system,
  • The patient, his trusted person or a relative present during his hospitalization have not expressed opposition to his participation in the research..

You may not qualify if:

  • End of life situation,
  • ADL at 0/6 for 15 days before hospitalization.
  • Refusal to participate,
  • Patient under judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, France

Location

Study Officials

  • Caroline BERBON

    University Hospital, Toulouse

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 15, 2023

Study Start

June 12, 2024

Primary Completion

May 20, 2025

Study Completion

May 20, 2025

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations