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

Not Applicable

Not yet recruiting

• Conditions: Critical Illness; Intensive Care Medicine

• Registration Number: NCT06923462
• Lead Sponsor: Vanderbilt University Medical Center

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.

Study Timeline

• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-04-03
• Study First Posted: 2025-04-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Study Start: 2025-06-30
• Primary Completion: 2027-03-15
• Study Completion: 2028-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess engagement among patients during acute hospitalization	Up to 14 days	Within the intervention group and control groups, engagement will be assessed through survey administered at ICU discharge