ClinConnect ClinConnect Logo
Search / Trial NCT06923462

VoiceLove: An App-Based COMMunication Tool Designed to Address DeliriUm and Improve Family ENgagement and PatIent/Family SatisfaCtion in CriticAlly Ill PaTiEnts (COMMUNICATE)

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Apr 3, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

The VoiceLove trial is studying a new phone app designed to help families and patients communicate better while in the intensive care unit (ICU). The app allows families to share information securely with their loved ones, aiming to improve family engagement, communication, and reduce confusion or delirium in critically ill patients. The trial will compare the use of the VoiceLove app with standard care to see if it really makes a difference.

To participate in this study, patients need to be at least 18 years old, currently admitted to a medical or coronary ICU, and on a breathing machine for more than 24 hours. However, some patients may not be eligible, such as those who cannot provide consent or have certain medical conditions. If eligible, participants can expect to use the VoiceLove app during their ICU stay, helping their family stay connected and informed about their care. This trial is not yet recruiting participants, but it represents an exciting step towards improving communication in critical care settings.

Gender

ALL

Eligibility criteria

  • 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:
  • 1. Adult patient ≥18 years old
  • 2. Admitted to medical or coronary ICU
  • 3. 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:
  • 1. Inability to obtain informed consent
  • Attending physician refusal
  • Patient and/or surrogate refusal
  • Patient unable to consent and no surrogate available
  • 2. Acute or chronic neurologic deficit precluding CAM-ICU assessments
  • 3. Inability to understand English
  • 4. Current enrollment in a study that does not allow co-enrollment
  • 5. Prisoners
  • 6. 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).
  • 7. Bilateral Deafness

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

E Wesley Ely, MD, MPH

Principal Investigator

Vanderbilt University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported