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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient participant | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VoiceLove therapy | Behavioral | VoiceLove digital interventions represent voice recordings, specifically, (i) Reorientation messages, and (ii) general communication domain calming and encouraging voice messages recorded in familiar voices from family and friends. Families will be guided to record and deliver Reorientation messages, that can be played to the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of VoiceLove digital therapy use by participants in the ICU | 70% of participants complete two 25-minute sessions of VoiceLove digital therapy per day for 3 days | Baseline to day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peripheral arterial oxygen saturation (SpO2) after VoiceLove digital therapy | Mean change in SpO2 during VoiceLove digital therapy sessions | Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3. |
| Change in blood pressure after VoiceLove digital therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of VoiceLove digital therapy | Proportion of participants with a system usability scale score >35 | Day of Hospital Discharge, Visit 8 |
| Delirium onset during the study | Proportion of participants with delirium onset |
Inclusion Criteria:
Exclusion Criteria:
Patients in the ICU who have
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Darrel Cleere, BSN RN CCRP | Contact | 713-441-6232 | dwcleere@houstonmethodist.org | |
| Shondra Word | Contact | 713-441-5122 | sword@houstonmethodist.org |
| Name | Affiliation | Role |
|---|---|---|
| Hina Faisal, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
The study does not allow release of individual participant data
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D060825 | Cognitive Dysfunction |
| D003221 | Confusion |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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The study is a single-center, single-arm, prospective trial
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|
Mean change in blood pressure during VoiceLove digital therapy sessions |
| Start of Voice Love digital therapy to 25 minutes of session on day 1, on day 2, and on day 3. |
| Change in respiratory rate after VoiceLove digital therapy | Mean change in respiratory rate during VoiceLove digital therapy sessions | Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3. |
| Change in heart rate after VoiceLove digital therapy | Mean change in heart rate during VoiceLove digital therapy sessions | Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3. |
| From start of VoiceLove digital therapy sessions at baseline through study completion, day 7 |
| Hypoactive delirium | Proportion of participants with hypoactive delirium | From start of VoiceLove digital therapy sessions at baseline through study completion, day 7 |
| Hyperactive delirium | Proportion of participants with hyperactive delirium | From start of VoiceLove digital therapy sessions at baseline through study completion, day 7 |
| Delirium severity | Proportion of participants with mild, moderate, or severe delirium | From start of VoiceLove digital therapy sessions at baseline through study completion, day 7 |
| Delirium days | Total number of delirium-positive days | From start of VoiceLove digital therapy sessions at baseline through study completion, day 7 |
| Readmissions to the ICU during the hospital stay | Total number of readmissions to the ICU | From last day in ICU to a return to ICU prior to hospital discharge, Visit 8 |
| Family satisfaction survey | Total score of system usability survey for family or caregiver member | ICU day 3, Visit 4 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |