VoiceLove Digital Therapy for Delirium in the ICU

The Methodist Hospital Research Institute (TMHRI)

Status: Enrolling

Conditions: Delirium

Treatments: Behavioral: VoiceLove therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07218484

PRO00041572

Details and patient eligibility

About

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. 15 participants will be enrolled. The study expects that 70% of participants will complete 20 -25 minutes of the VoiceLOVE digital therapy. Descriptive statistics will be used to summarize the findings. The intent is that this study will provide information for a larger, subsequent clinical trial of surgical ICU patients who are at risk for delirium.

Full 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 morning and in the evening and will play for 20-25 minutes each session.

Participants will have a pre-operative visit, 3 consecutive intervention visits with vital signs assessment, 7 days of assessments of Confusion Assessment Methods (CAM)-ICU (morning and evening), and 7 days of a Richmond Agitation-Sedation Scale assessment. The participant will provide an assessment of the acceptability of the VoiceLove digital therapy using a system usability scale score at the end of their participation in the study.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. At risk of delirium, as per ICU delirium risk score or existing diagnosis
3. Family members or caregivers involved in patient care at least 18 years of age.
4. Clinical team members caring for the patients

Exclusion criteria

• Patients in the ICU who have

  1. a history of severe mental illness,
  2. admission for a drug overdose,
  3. severe vertigo,
  4. a history of severe postoperative nausea and vomiting,
  5. hearing or visual impairments,
  6. preexisting severe dementia (Montreal Cognitive Assessment Score <15),
  7. neurological surgeries.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Patient participant

Experimental group

Description:

Two sessions per day of VoiceLove digital therapy will be administered with each session lasting 20-25 minutes. Sessions will occur during days 1-3 while the participant is in bed and in an alert and calm state.

Treatment:

Behavioral: VoiceLove therapy