Houston Methodist Hospital
Houston, Texas, 77030, United States
Location status: Recruiting
NCT Number: NCT07218484
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline to day 3
70% of participants complete two 25-minute sessions of VoiceLove digital therapy per day for 3 days
Time frame: Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.
Mean change in SpO2 during VoiceLove digital therapy sessions
Time frame: Start of Voice Love digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.
Mean change in blood pressure during VoiceLove digital therapy sessions
Time frame: Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.
Mean change in respiratory rate during VoiceLove digital therapy sessions
Time frame: Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.
Mean change in heart rate during VoiceLove digital therapy sessions
Time frame: Day of Hospital Discharge, Visit 8
Proportion of participants with a system usability scale score >35
Time frame: From start of VoiceLove digital therapy sessions at baseline through study completion, day 7
Proportion of participants with delirium onset
Time frame: From start of VoiceLove digital therapy sessions at baseline through study completion, day 7
Proportion of participants with hypoactive delirium
Time frame: From start of VoiceLove digital therapy sessions at baseline through study completion, day 7
Proportion of participants with hyperactive delirium
Time frame: From start of VoiceLove digital therapy sessions at baseline through study completion, day 7
Proportion of participants with mild, moderate, or severe delirium
Time frame: From start of VoiceLove digital therapy sessions at baseline through study completion, day 7
Total number of delirium-positive days
Time frame: From last day in ICU to a return to ICU prior to hospital discharge, Visit 8
Total number of readmissions to the ICU
Time frame: ICU day 3, Visit 4
Total score of system usability survey for family or caregiver member
Contact information is provided by the study sponsor or research team.
Darrel Cleere, BSN RN CCRP
CONTACT
Shondra Word
CONTACT
The Methodist Hospital Research Institute
Other
Feasibility of VoiceLove Digital Therapy for Delirium Management in ICU Patients: A Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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