VoiceLove: An App-Based COMMunication Tool Designed to Address DeliriUm and Improve Family ENgagement and PatIent/Family SatisfaCtion in CriticAlly Ill PaTiEnts (COMMUNICATE)
COMMUNICATE
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2025
CompletedFirst Posted
Study publicly available on registry
April 11, 2025
CompletedStudy Start
First participant enrolled
August 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2028
August 27, 2025
August 1, 2025
1.6 years
March 6, 2025
August 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Assess engagement among patients during acute hospitalization
Within the intervention group and control groups, engagement will be assessed through survey administered at ICU discharge
Up to 14 days
Study Arms (2)
Usual Care recipients
NO INTERVENTIONParticipants in this arm will be randomized to usual care, or no VoiceLove utilization while in the ICU.
VoiceLove recipients
EXPERIMENTALParticipants in this arm will be randomized to utilize VoiceLove while in the ICU.
Interventions
Participants will receive the VoiceLove intervention versus the standard care which does not utilize VoiceLove.
Eligibility Criteria
You may not qualify if:
- Adult patient ≥18 years old
- Admitted to medical or coronary ICU
- Intubated on mechanical ventilation with expected intubation of \> 24 hours
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
E Wesley Ely, MD, MPH
Vanderbilt University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Director, CIBS Center
Study Record Dates
First Submitted
March 6, 2025
First Posted
April 11, 2025
Study Start
August 6, 2025
Primary Completion (Estimated)
March 15, 2027
Study Completion (Estimated)
March 15, 2028
Last Updated
August 27, 2025
Record last verified: 2025-08