Duke University Hospital
Durham, North Carolina, 27710, United States
NCT Number: NCT05544162
This is a Pilot study designed to set up for an randomized clinical trial (RCT) comparing the SeND Home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 3:1 to either SeND Home precision nutrition pathway or control arm. Subjects randomized to the SeND Home arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
This is a Pilot study designed to set up for an randomized clinical trial (RCT) comparing the SeND Home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. The SeND Home Pathway supports patients from ICU admission to 2-weeks post-hospital discharge, providing a comprehensive and personalized plan of care carried to completion.
Subjects will be randomized 3:1 to either SeND Home precision nutrition pathway or control arm. Subjects randomized to the SeND Home arm will receive oral nutrition supplements (Ensure shakes) up to 3 times per day while in the hospital and for 4 weeks after discharge. Some subjects in this arm will be asked to participate in an interview after being discharged from the hospital. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers.
Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass. They will also be asked to complete walking and strength tests, and surveys about quality of life.These will be done every 3-7 days during hospitalization, at hospital discharge, and at a 3 month post-discharge follow-up visit.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
Time frame: Baseline
This outcome is a measure of feasibility of the SeND Home pathway
Time frame: approximately 98 days
This outcome is a measure of feasibility of the SeND Home pathway
Time frame: hospital stay plus 90 days
This outcome is a measure of feasibility of the SeND Home pathway
Time frame: 3 months
This outcome is an assessment of feasibility (participant burden)
Time frame: 3 months
This outcome is an assessment of feasibility (participant burden)
Time frame: 3 months
This outcome is an assessment of feasibility (participant burden)
Time frame: 3 months
This outcome is an assessment of feasibility (participant burden)
Time frame: 18 months
This outcome is a measure of acceptability and will be used to iteratively adapt the SeND home design as progress throughout the study
Time frame: 18 months
This outcome is a measure of acceptability and will be used to iteratively adapt the SeND home design as progress throughout the study
Time frame: 18 months
The outcome is a measure of the fidelity of SeND Home
Duke University
Other
Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Resilience in Older Adult Trauma Patients
Acronym: SeND Home
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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