Communication Tool Evaluation on Intensive Care Patients.
PICT'REA
A Communication Tool's Evaluation on Intensive Care Patients Equipped With Ventilation Systems.
1 other identifier
interventional
94
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
1 active site
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
CompletedStudy Start
First participant enrolled
December 13, 2021
CompletedFirst Posted
Study publicly available on registry
January 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2022
CompletedJanuary 31, 2024
January 1, 2024
6 months
October 21, 2021
January 29, 2024
Conditions
Keywords
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 INTERVENTIONPatients will have the usual communication tools (pen and paper, hands gestures...)
AFTER PICT'REA introduction
EXPERIMENTALPatients will be given a tablet to communicate with the caregivers whenever needed
Interventions
The pictograms communication tool "PICT'REA" will be available to patients with invasive ventilation systems preventing them from speaking
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fanny VARDON-BOUNES, MD
University Hospital, Toulouse
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