An interventional study of Communication Application in Critical Illness and Intensive Care Medicine, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Supportive care
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 improves patient-family communication, family engagement, and ICU delirium.
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 otherwise unable to communicate, VoiceLove allows family members to deliver real-time voice messages when they are away from the bedside without relying on the clinical team to coordinate calls. The investigator group has recently completed formative usability testing of the VoiceLove application with a variety of ICU stakeholders including family members, bedside ICU nurses, and ICU physicians to refine and optimize the app for clinical use in the ICU. During usability testing, stakeholders overall viewed the app favorably and expressed interest in tools to enhance communication in the ICU. As compared to traditional methods of communication, stakeholders identified the ability to customize messaging by unique family groups and to archive and replay messages as strengths. While promising as a tool to improve family engagement in the ICU, it has yet to undergo evaluation in the ICU to assess feasibility and acceptability of use.
The goal in this prospective, mixed method randomized control trial (RCT) is to compare VoiceLove implementation to usual care to investigate the effect of VoiceLove on optimizing patient-family communication, family engagement, and ICU delirium prevalence.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
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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:
Exclusion Criteria
Patients will be excluded (i.e., not consented) for any of the following reasons:
Inability to obtain informed consent
Participants in this arm will be randomized to usual care, or no VoiceLove utilization while in the ICU.
Participants in this arm will be randomized to utilize VoiceLove while in the ICU.
Other: Communication Application
Participants will receive the VoiceLove intervention versus the standard care which does not utilize VoiceLove.
To assess communication and engagement among patients and family members during hospitalization. The primary feasibility outcome is app engagement among participants randomized to the intervention arm.
Engagement will be characterized using prespecified metrics, including the number of messages played to the patient, duration of app use, and other measures of app utilization during the ICU stay.
Time frame: Up to 14 days
Plan to share: Undecided — Plans for sharing data are being developed.
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Vanderbilt University Medical Center