Communication, NonverbalPICT'REANCT05176457
Communication Tool Evaluation on Intensive Care Patients.
A study testing communication tool PICT'REA in people with Communication, Nonverbal, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication, Nonverbal
- What is being tested?
- communication tool PICT'REA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2021to 16 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to use the device:
- Blind or visually impaired
- Severe paresis of the upper limbs
- No understanding of the tool.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Communication Tool's Evaluation on Intensive Care Patients Equipped With Ventilation Systems.
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.
Read the detailed description
Invasive mechanical ventilation is commonly used in intensive care, in sedated patients but also in perfectly conscious patients, and this on a daily basis.
For these patients, the resulting deprivation of oral expression is a major source of stress and discomfort. On the side of the caregivers, the difficulty of comprehension is a source of frustration on a daily basis.
Thus PICT'REA has been developped in order to help patients and caregivers to better understand each other during invasive ventilation.
PICT'REA is a tool in the form of a mobile app with simple pictograms allowing simple communication (Yes/No/Pain chart...).
The study will analyze the quality of communication between patients and caregivers before and after the introduction of the application:
- Before setting up the tool: control group
- Over a period of 6 months
- In the multi-purpose resuscitations of Cardio Vascular Surgery and Neurosurgery.
- After setting up the tool:
- Over a period of 6 months
- In the same departments.
The analyses consists of various questionnaires :
- the modified Ease of Communication Scale,
- a Short questionnaire in 3 questions for caregivers,
- IPREA questionnaire for patients,
- Evaluation of the usability of the system by System Usability Scale questionnaire,
- Evaluation of the attractiveness of the system by Attrackdiff questionnaire.
- Conditions
- Communication, Nonverbal
- Being tested
- communication tool PICT'REA
- Keywords
- intensive care, communication tool, invasive ventilation, speaking impairment, technology
- Medical subject headings
- Nonverbal Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication tool PICT'REAOther
The pictograms communication tool "PICT'REA" will be available to patients with invasive ventilation systems preventing them from speaking
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: communication tool PICT'REA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.
Measured: after PICT'REA introduction (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start13 Dec 2021
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication, NonverbalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny VARDON-BOUNES, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176457
- Sponsor's protocol ID
- RC31/21/0427
- Acronym
- PICT'REA
- Status last verified
- Jan 2024
- First submitted
- 21 Oct 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Communication Tool's Evaluation on Intensive Care Patients Equipped With Ventilation Systems.
- ClinicalTrials.gov ID
- NCT05176457
- Acronym / sponsor ID
- PICT'REA / RC31/21/0427
- Conditions
- Communication, Nonverbal
- Keywords
- intensive care, communication tool, invasive ventilation, speaking impairment, technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Invasive mechanical ventilation is commonly used in intensive care, in sedated patients but also in perfectly conscious patients, and this on a daily basis.
For these patients, the resulting deprivation of oral expression is a major source of stress and discomfort. On the side of the caregivers, the difficulty of comprehension is a source of frustration on a daily basis.
Thus PICT'REA has been developped in order to help patients and caregivers to better understand each other during invasive ventilation.
PICT'REA is a tool in the form of a mobile app with simple pictograms allowing simple communication (Yes/No/Pain chart...).
The study will analyze the quality of communication between patients and caregivers before and after the introduction of the application:
- Before setting up the tool: control group
- Over a period of 6 months
- In the multi-purpose resuscitations of Cardio Vascular Surgery and Neurosurgery.
- After setting up the tool:
- Over a period of 6 months
- In the same departments.
The analyses consists of various questionnaires :
- the modified Ease of Communication Scale,
- a Short questionnaire in 3 questions for caregivers,
- IPREA questionnaire for patients,
- Evaluation of the usability of the system by System Usability Scale questionnaire,
- Evaluation of the attractiveness of the system by Attrackdiff questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEFORE PICT'REA introduction | No intervention | –Patients will have the usual communication tools (pen and paper, hands gestures...) |
| AFTER PICT'REA introduction | Experimental | Other: communication tool PICT'REAPatients will be given a tablet to communicate with the caregivers whenever needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Blind or visually impaired
- Severe paresis of the upper limbs
- No understanding of the tool.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| communication tool PICT'REAThe pictograms communication tool "PICT'REA" will be available to patients with invasive ventilation systems preventing them from speaking | Other | AFTER PICT'REA introduction |
Primary outcome
Ease of Communication
Time frame: before PICT'REA introduction (Baseline)
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.)
Ease of Communication
Time frame: after PICT'REA introduction (6 months)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny VARDON-BOUNES, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication tool PICT'REA in people with Communication, Nonverbal, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of Communication (time frame: before PICT'REA introduction (Baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.