- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06169774
Video Training Supplementation for Patients Discharged on Home Parental Nutrition
May 7, 2026 updated by: University of Chicago
Video Training Supplementation to Reduce the Risk of Central Venous Catheter Infection in Patients Discharged on Home Parental Nutrition
The goal of this clinical trial is to develop an educational video addressing the aseptic techniques to safely handle central catheters for administrating parenteral nutrition at home.
Study Overview
Detailed Description
Home parenteral nutrition is an alternative form of providing nutrition to people whose digestive systems either can't absorb or tolerate food eaten by mouth.
Parenteral nutrition provides liquid nutrients, including carbohydrates, proteins, fats, vitamins, minerals and electrolytes.
In recent years, more emphasis has been placed on delivering parenteral nutrition to patients at home.
Studies have shown that patients receiving home parenteral nutrition are at higher risk for bloodstream infections compared to other patients with chronic infusion needs.
Catheter-related bloodstream infection is a major cause of mortality and morbidity in patients receiving parenteral nutrition.
It is important to maintain safe vascular access to prevent life-threatening complications.
This study aims to assess the effectiveness of the video training on the rate of catheter related bloodstream infection over a 12-month period of time.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Taking home parenteral nutrition for the first time
- Willing to self-administer parenteral nutrition
- Age ≥ 18 yrs
- Able to provide informed consent
- Able speak and understand English
Exclusion Criteria:
- Already taking home parenteral nutrition
- not willing to self-administer parenteral nutrition
- Age < 18 years-old
- Unable to provide informed consent
- Non-English speakers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Educational video
Participants will be asked to watch an education video addressing aseptic techniques to safely handle central catheters at home during parenteral nutrition infusions.
|
Watch the 17-minute educational video as many times as needed within a 12-month period.
|
|
No Intervention: No educational video
Participants will be managed according to routine care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative analysis of catheter related bloodstream infection (CRBI) events
Time Frame: baseline-12 months
|
Change in number of CRBI events measured by complete blood count test.
|
baseline-12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carol Semrad, MD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
January 21, 2026
Study Completion (Actual)
May 5, 2026
Study Registration Dates
First Submitted
December 5, 2023
First Submitted That Met QC Criteria
December 5, 2023
First Posted (Actual)
December 13, 2023
Study Record Updates
Last Update Posted (Actual)
May 8, 2026
Last Update Submitted That Met QC Criteria
May 7, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB23-1285
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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