Feasibility Assessment of Implementing a Care System to PREVENT Iatrogenic Dependency (ID) (PREVENT-ID)

April 2, 2024 updated by: University Hospital, Toulouse

Feasibility Assessment of Implementing a Care System to PREVENT Iatrogenic Dependency (ID) Related to Hospitalization in People Over 70 Years : Pilot Study. PREVENT-ID

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France
        • Chu de Toulouse
        • Contact:
        • Principal Investigator:
          • Véronique ABBAL
        • Principal Investigator:
          • Caroline BENHAYOUN SADAFI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

inclusion criteria:

  • 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..

exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ID prevention unit
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
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.
Sham Comparator: Control unit
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
standard care without any specific system in place

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants with loss of independence
Time Frame: 15 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Study Director: Caroline BERBON, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 4, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC31/21/0171

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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