NCT05544162

Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients

Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Resilience in Older Adult Trauma Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Trauma
• Critical Illness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutrition supplement - Ensure shakes	Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.

Timeline

• Start date: 2023-01-05
• Primary completion: 2024-02-01
• Completion: 2024-07-26
• First posted: 2022-09-16
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States