Communication App for Delirium

(COMMUNICATE Trial)

Overseen By Rebecca Abel, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Neurologic deficit, Non-English, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 14 days

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a phone app called VoiceLove, designed to improve communication between families and patients in the ICU. The researchers aim to determine if VoiceLove can enhance communication, increase family involvement, and reduce ICU delirium (confusion or disorientation). Participants will either use the VoiceLove app or receive usual care without it. The trial seeks patients who are intubated on a ventilator in the ICU and expected to require it for more than 24 hours. As an unphased trial, participation offers an opportunity to contribute to innovative research that could enhance ICU patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the VoiceLove app is safe for use in ICU patients?

Research shows that the VoiceLove app is safe for patients. A previous study examined its ease of use, safety, and patient satisfaction, finding no serious safety issues. Most participants used the app for 20-25 minutes, indicating its user-friendliness.

The app enhances communication between patients and their families in the ICU. By keeping families involved, it aims to reduce the risk of delirium, a sudden change in brain function that causes confusion. No reports of problems have emerged from using the app, making it a promising option for patients and families.

Overall, evidence supports the safety of VoiceLove for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VoiceLove because it offers a novel way to support ICU patients experiencing delirium through a communication app. Unlike traditional treatments that might rely on medications or physical restraints to manage delirium, VoiceLove uses voice interactions to engage patients, potentially reducing confusion and distress. This approach is non-invasive and emphasizes emotional support, aiming to improve patient outcomes by enhancing their connection with caregivers and loved ones during a challenging time.

What evidence suggests that the VoiceLove app is effective for improving patient-family communication and reducing ICU delirium?

Research has shown that hearing familiar voices can help reduce confusion in ICU patients. One study found that patients who listened to recordings of their family members experienced more days without confusion compared to those who received standard care. This suggests that familiar voices might calm and help orient patients, possibly reducing the risk or severity of confusion. In this trial, participants in the VoiceLove recipients arm will use the VoiceLove app, which allows families to securely share voice messages with patients. This could improve communication and involvement, which are important in managing confusion. Participants in the Usual Care recipients arm will receive standard care without using VoiceLove. ^{1 2 5 6 7}

Who Is on the Research Team?

E Wesley Ely, MD, MPH

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for critically ill patients in the ICU who may experience delirium. It's designed to see if better communication between these patients and their families can be achieved using the VoiceLove app, compared to standard methods.

Inclusion Criteria

Only patients who meet inclusion criteria, have no

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the VoiceLove app or receive usual care during their ICU stay

Up to 14 days

Continuous monitoring during ICU stay

Follow-up

Participants are monitored for engagement and communication effectiveness after ICU discharge

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VoiceLove

Trial Overview The study is testing the effectiveness of the VoiceLove app, a secure platform for sharing information between ICU patients and their families, in improving communication, family involvement, and reducing ICU delirium.

How Is the Trial Designed?

Group I: VoiceLove recipients Experimental Treatment 1 Intervention

Participants in this arm will be randomized to utilize VoiceLove while in the ICU.

Group II: Usual Care recipients Active Control 1 Intervention

Participants in this arm will be randomized to usual care, or no VoiceLove utilization while in the ICU.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07218484

VoiceLove Digital Therapy for Delirium in the ICU A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A ...

2. reporter.nih.gov reporter.nih.gov/project-details/10602709

VoiceLove AD/ADRD patients who develop delirium have a marked increase in adverse outcomes including rate of cognitive decline, institutionalization, and death following ...

3. aacnjournals.org aacnjournals.org/ajcconline/article/34/6/429/32879/Delirium-Reduction-via-Scripted-Family-Voice

Delirium Reduction via Scripted Family Voice Recordings in ... Data analyses included descriptive statistics, χ2 tests, and multivariable modeling analysis following the intent-to-treat principle. Results.

4. aacn.org aacn.org/newsroom/familiar-voices-may-help-keep-icu-delirium-at-bay

Familiar Voices May Help Keep ICU Delirium at Bay Patients in the FAVoR intervention group had a higher rate of delirium-free days than patients in the control group who received usual care. The ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06923462

Study Details | NCT06923462 | VoiceLove: An App-Based ... This project will compare the VoiceLove app to usual care to learn about whether VoiceLove improves patient-family communication, family engagement, and ICU ...

6. atsjournals.org atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A5402

Patient and Family Communication in the Intensive Care ... Patient and Family Communication in the Intensive Care Unit (ICU): Development and Usability Testing of the VoiceLove Mobile Phone App to Study Delirium Risk.

7. withpower.com withpower.com/trial/phase-confusion-7-2025-50763

VoiceLove Digital Therapy for Delirium The study expects that 70% of participants will complete 20 -25 minutes of the VoiceLOVE digital therapy. Descriptive statistics will be used to ...