Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06923462
Acronym
COMMUNICATE
Enrollment
100
Registered
2025-04-11
Start date
2025-08-06
Completion date
2028-03-15
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Intensive Care Medicine

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 improves patient-family communication, family engagement, and ICU delirium.

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 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.

Interventions

OTHERCommunication Application

Participants will receive the VoiceLove intervention versus the standard care which does not utilize VoiceLove.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.Up to 14 daysEngagement 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.

Countries

United States

Contacts

CONTACTChristina Boncyk, MD, MPH
christina.s.boncyk@vumc.org615-936-2857
CONTACTRebecca Abel, MA
rebecca.abel@vumc.org615-875-3763
PRINCIPAL_INVESTIGATORE Wesley Ely, MD, MPH

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026