CTSI-iPad for Vented Patient Communication
iPad
A Randomized Controlled Trial of an iPad for Patient Communication During Mechanical Ventilation
2 other identifiers
interventional
21
1 country
1
Brief Summary
This study will enroll 75 mechanically vented adults in the ICU to compare self-reported ease of communication, patient satisfaction, and patient anxiety and frustration levels between a group using a communication application on an iPad and a group using standard methods of communication while mechanically vented.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
Longer than P75 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
Study Start
First participant enrolled
February 23, 2017
CompletedFirst Submitted
Initial submission to the registry
March 9, 2017
CompletedFirst Posted
Study publicly available on registry
May 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2020
CompletedMay 20, 2021
May 1, 2021
3.6 years
March 9, 2017
May 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Ease of Communication
Patient self-reported ease of communication during mechanical ventilation measured using a Likert scale
30 Days
Secondary Outcomes (2)
Patient Anxiety
30 Days
Patient Satisfaction
30 Days
Study Arms (2)
Standard Communication
PLACEBO COMPARATORStandard of Care communication styles will be used. Patients will receive the standard communication protocol identified by the hospital.
iPad with Speech App
EXPERIMENTALUse of application Proloquo2Go on iPad device. The application being used is called Proloquo2Go which is the intervention portion. The iPad is the device used to access the application.
Interventions
Use of communication application Proloquo2Go modified for the ICU setting on an iPad device
Eligibility Criteria
You may qualify if:
- Sufficient motor and visual function to allow use of touch screen
- Mechanically ventilated
- Awake and able to participate in informed consent discussion
You may not qualify if:
- Non-English Speaking
- Receiving ventilator support prior to admission.
- Delirium present in the last 24 hours
- Tracheostomy
- Structural Neurological Injury (such as stroke or traumatic brain injury)
- Coma
- Deep Sedation (Richmond Agitation Scale \> -2)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- Marquette Universitycollaborator
Study Sites (1)
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rahul Nanchal, MD, MS
Medical College of Wisconsin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine and Director of the Medical Intensive Care Unit
Study Record Dates
First Submitted
March 9, 2017
First Posted
May 23, 2017
Study Start
February 23, 2017
Primary Completion
September 21, 2020
Study Completion
September 21, 2020
Last Updated
May 20, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
No plan to share.