NCT05176457

Brief Summary

The present study evaluate the impact of a communication tool "PICT'REA" on patients in reanimation units, equipped with ventilation systems, preventing them from speaking. The app consists of simple pictograms allowing simple communication between patients and the reanimation care team. The study will assess the quality of communication before and after the introduction of the communication tool in the reanimation unit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

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

October 21, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2022

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

October 21, 2021

Last Update Submit

January 29, 2024

Conditions

Keywords

intensive carecommunication toolinvasive ventilationspeaking impairmenttechnology

Outcome Measures

Primary Outcomes (2)

  • Ease of Communication

    The modified Ease of Communication Scale (ECS), comprising 8 questions of 1 to 5 points, for a maximum total of 40 points. The lower the score, the easiest the communication is. This is regarding patients using traditional communication methods (slate, alphabet, lip reading, etc.)

    before PICT'REA introduction (Baseline)

  • Ease of Communication

    The modified Ease of Communication Scale (ECS), comprising 8 questions of 1 to 5 points, for a maximum total of 40 points. The lower the score, the easiest the communication is. This is regarding patients using the PICT REA application.

    after PICT'REA introduction (6 months)

Study Arms (2)

BEFORE PICT'REA introduction

NO INTERVENTION

Patients will have the usual communication tools (pen and paper, hands gestures...)

AFTER PICT'REA introduction

EXPERIMENTAL

Patients will be given a tablet to communicate with the caregivers whenever needed

Other: communication tool PICT'REA

Interventions

The pictograms communication tool "PICT'REA" will be available to patients with invasive ventilation systems preventing them from speaking

AFTER PICT'REA introduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized in intensive care or intensive care
  • ventilated on a tracheostomy or an orotracheal intubation tube for\> 24 hours
  • not too agitated or too sedated (RASS -1 to +2) for\> 24 hours
  • Confusion Assessment Method (CAM) ICU negative
  • Speak or read French

You may not qualify if:

  • Inability to use the device:
  • Blind or visually impaired
  • Severe paresis of the upper limbs
  • No understanding of the tool.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Nonverbal Communication

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Fanny VARDON-BOUNES, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2021

First Posted

January 4, 2022

Study Start

December 13, 2021

Primary Completion

June 16, 2022

Study Completion

June 16, 2022

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations