Status:
RECRUITING
VoiceLove: An App-Based COMMunication Tool Designed to Address DeliriUm and Improve Family ENgagement and PatIent/Family SatisfaCtion in CriticAlly Ill PaTiEnts (COMMUNICATE)
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Critical Illness
Intensive Care Medicine
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
VoiceLove is a phone application allowing family and patients to share information in a secure platform. This project will compare the VoiceLove app to usual care to learn about whether VoiceLove impr...
Detailed Description
VoiceLove is a novel, HIPAA compliant mobile phone application that enables families and patients to securely exchange and archive voice messages in real-time. For patients who are intubated or otherw...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Only patients who meet inclusion criteria, have no exclusion criteria, and consent for participation will advance to the Interventional Trial phase (i.e., the randomization phase) of the study. Patients will be eligible for inclusion in the Pre-Randomization Phase of the study (i.e., presented for study consent) if they are:
- Adult patient ≥18 years old
- Admitted to medical or coronary ICU
- Intubated on mechanical ventilation with expected intubation of \> 24 hours
- Exclusion Criteria
- Patients will be excluded (i.e., not consented) for any of the following reasons:
- Inability to obtain informed consent
- Attending physician refusal
- Patient and/or surrogate refusal
- Patient unable to consent and no surrogate available
- Acute or chronic neurologic deficit precluding CAM-ICU assessments
- Inability to understand English
- Current enrollment in a study that does not allow co-enrollment
- Prisoners
- Expected death or comfort measures within 24 hours of enrollment or lack of commitment to intervention by family or the medical team (e.g., likely to withdraw life support measures within 24 hours of enrollment).
- Bilateral Deafness
Exclusion
Key Trial Info
Start Date :
August 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06923462
Start Date
August 6 2025
End Date
March 15 2028
Last Update
August 27 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232