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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06923462
Status
Recruiting
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Conditions

  • Critical Illness
  • Intensive Care Medicine

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Communication Application — OTHER
    Participants will receive the VoiceLove intervention versus the standard care which does not utilize VoiceLove.

Study Details

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.

Key Dates

First listed
Apr 11, 2025
Start date
Aug 6, 2025
Status verified
Aug 2026
Primary completion
Mar 15, 2027
Completion
Mar 15, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual Care recipients
    Participants in this arm will be randomized to usual care, or no VoiceLove utilization while in the ICU.
  • Experimental: VoiceLove recipients
    Participants in this arm will be randomized to utilize VoiceLove while in the ICU.

Primary Outcome Measure

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. [ Time Frame: Up to 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Christina Boncyk, MD
[email protected]
(615)936-2857
Rebecca Abel
[email protected]
615-875-3763
E. Wesley Ely, MD, MPH (PRINCIPAL_INVESTIGATOR)

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Vanderbilt University Medical Center· Nashville, TN

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