Status:
RECRUITING
VoiceLove Digital Therapy for Delirium in the ICU
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Delirium
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a single-center, single-arm, prospective trial to evaluate the feasibility, safety, and acceptability of VoiceLOVE digital therapy for the management of delirium in surgical ICU patients....
Detailed Description
VoiceLove digital therapy includes voice recordings of the participant's loved one delivered at the bedside via a smartphone attached to the bed. The VoiceLove digital therapy will be delivered in the...
Eligibility Criteria
Inclusion
- Men and women aged ≥18 years admitted to the hospital after major surgery (elective or non-elective) require a hospital stay of at least five days following surgery, including an ICU stay for at least three days after the surgical procedure
- At risk of delirium, as per ICU delirium risk score or existing diagnosis
- Family members or caregivers involved in patient care at least 18 years of age.
- Clinical team members caring for the patients
Exclusion
- Patients in the ICU who have
- a history of severe mental illness,
- admission for a drug overdose,
- severe vertigo,
- a history of severe postoperative nausea and vomiting,
- hearing or visual impairments,
- preexisting severe dementia (Montreal Cognitive Assessment Score \<15),
- neurological surgeries.
Key Trial Info
Start Date :
August 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07218484
Start Date
August 21 2025
End Date
January 31 2026
Last Update
October 20 2025
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030