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

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06923462 (COMMUNICATE) ist eine interventionsstudie zur Untersuchung von Kritische Erkrankung, Intensive Care Medicine und hat den Status offene rekrutierung. Die Studie startete am 6. August 2025 und soll 100 Teilnehmer aufnehmen. Durchgeführt von Vanderbilt University ist der Abschluss für 15. März 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. August 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.

Offizieller Titel

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

Erkrankungen
Kritische ErkrankungIntensive Care Medicine
Weitere Studien-IDs
  • COMMUNICATE
  • 242209
NCT-Nummer
Studienbeginn (tatsächlich)
2025-08-06
Zuletzt aktualisiert
2025-08-27
Studienende (vorauss.)
2028-03-15
Geplante Rekrutierung
100
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Keine InterventionUsual Care recipients
Participants in this arm will be randomized to usual care, or no VoiceLove utilization while in the ICU.
Nicht zutreffend
ExperimentellVoiceLove recipients
Participants in this arm will be randomized to utilize VoiceLove while in the ICU.
Communication Application
Participants will receive the VoiceLove intervention versus the standard care which does not utilize VoiceLove.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle

  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

Verantwortliche Partei
Wes Ely, Hauptprüfer, Co-Director, CIBS Center, Vanderbilt University Medical Center
Zentrale Studienkontakte
Kontakt: Christina Boncyk, MD, MPH, 615-936-2857, [email protected]
Kontakt: Rebecca Abel, MA, 615-875-3763, [email protected]
1 Studienstandorte in 1 Ländern

Tennessee

Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
Christina Boncyk, MD, Kontakt, (615)936-2857, [email protected]
Rebecca Abel, Kontakt, 615-875-3763, [email protected]
E. Wesley Ely, MD, MPH, Hauptprüfer
Offene Rekrutierung