NCT04991558

Brief Summary

France currently has more than 10 million disabled people, including 3 millions who could be better treated. In fact, people with disabilities face many obstacles in accessing care and receiving appropriate support (physical access to certain locations, communication...). Difficulties are also encountered by the healthcare staff, leading to often heterogeneous practices in health establishments. The INFRA health circuit has been set up at the "Groupe Hospitalier Mutualiste de Grenoble" since June 2018 according to the guidelines published by the French High Authority for Health (HAS) on improving professional practices "Reception, support and organization of care in health establishments for people in situation of handicap "of July 2017. The INFRA nurse collects and anticipates the necessary adaptations for the patient's stay, in conjunction with their caregivers (whether family or institutional). They are an interface with other healthcare professionals to adapt care procedures and protocols (body care, feeding methods, pain management, drug management) to the patient's disability. Before hospitalization and until the patient is discharged, the INFRA nurse transmits to the personnel involved all the information necessary for the proper continuation of care. In addition to legal and regulatory obligations, the INFRA nurse ensures the effective accessibility of the establishment's facilities and premises, and helps maintaining patient autonomy. The INFRA study is an observational study aimed at assessing the feasibility of the INFRA health circuit and evaluating the benefit for the patients and the healthcare staff.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

December 29, 2020

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients who followed the entirety of INFRA circuit

    At discharge, assessed up to 4 weeks

Secondary Outcomes (4)

  • Type of pain evaluation scale selected by the INFRA nurse

    enrollment

  • Number of healthcare adaptations implemented during hospitalization

    At discharge, assessed up to 4 weeks

  • Satisfaction of patients and caregivers

    At discharge, assessed up to 4 weeks

  • Satisfaction of healthcare staff

    At discharge, assessed up to 4 weeks

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with physical or mental disability, planned for surgical procedure and requiring an adaptation of their healthcare circuit

You may qualify if:

  • years old or more
  • Physical or mental disability, according to french law n°2005-102 of February 11th, 2005
  • Requiring an adaptation of the healthcare circuit
  • Indication of a planned surgical procedure

You may not qualify if:

  • Outpatient
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2020

First Posted

August 5, 2021

Study Start

September 3, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations