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Completed

NCT Number: NCT05544162

Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients

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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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition supplement - Ensure shakes

Dietary Supplement

Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.

Primary outcomes

  1. Number of Patients Recruited

    Time frame: Baseline

    This outcome is a measure of feasibility of the SeND Home pathway

Secondary outcomes

  1. Number of Study Participants Who Adhere to the SeND Home Treatment Protocol

    Time frame: approximately 98 days

    This outcome is a measure of feasibility of the SeND Home pathway

  2. Percentage of Participants Retained to Study Completion

    Time frame: hospital stay plus 90 days

    This outcome is a measure of feasibility of the SeND Home pathway

  3. Time to Complete Each Outcome

    Time frame: 3 months

    This outcome is an assessment of feasibility (participant burden)

  4. How Well Outcome Assessments Are Tolerated

    Time frame: 3 months

    This outcome is an assessment of feasibility (participant burden)

  5. Duration of Testing Time

    Time frame: 3 months

    This outcome is an assessment of feasibility (participant burden)

  6. Ability to Successfully Complete Testing in One Cycle Will be Recorded

    Time frame: 3 months

    This outcome is an assessment of feasibility (participant burden)

  7. Provider Satisfaction With SeND Home

    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

  8. Provider Assessment of Usefulness of SeND Home

    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

  9. Number of Interventions Delivered Per Protocol in the ICU, on the Floor, and In-home

    Time frame: 18 months

    The outcome is a measure of the fidelity of SeND Home

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: SeND Home

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2022
Registry last updated
Jun 2, 2026

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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