Recruiting

VoiceLove vs. Usual Care

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06923462

Conditions

Critical Illness

Intensive Care Medicine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Communication Application

Study Details

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.

Conditions

Critical Illness

Intensive Care Medicine

Study ID

NCT06923462

Start date

Aug 6, 2025

Status verified date

Aug, 2025

Completion date

Mar 15, 2028

Anticipated

Primary completion date

Mar 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Exclusion Criteria

Patients will be excluded (i.e., not consented) for any of the following reasons:

1. Inability to obtain informed consent

  • Attending physician refusal
  • Patient and/or surrogate refusal
  • Patient unable to consent and no surrogate available
2. Acute or chronic neurologic deficit precluding CAM-ICU assessments
3. Inability to understand English
4. Current enrollment in a study that does not allow co-enrollment
5. Prisoners
6. 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).
7. Bilateral Deafness

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Communication Application

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

Primary outcome measure

  • Assess engagement among patients during acute hospitalization [ Time Frame: Up to 14 days ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

E. Wesley Ely, MD, MPH

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Aug 27, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-08-27.