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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05544162
Other study ID # Pro00110867
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 5, 2023
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date June 30, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Patients who are at least 60 years old and admitted to the trauma service - Patients who have had a standard of care CT scan Exclusion Criteria: - Expected withdrawal of life-sustaining treatment within 48 hours - Prisoners - Unable to provide informed consent - Non-English speakers - Traumatic Brain Injury - Allergic to milk or soy ingredients (Common allergen in Ensure shakes). - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Duke University Hospital Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of SeND Home pathway Enrollment goal of 90% 18 months
Secondary Acceptability of SeND Home pathway Measured by interviewing enrolled subjects and stakeholders 24 months
Secondary Fidelity of SeND Home pathway Measured by the proportion of interventions delivered per protocol with a goal of 80% 18 months
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