Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home Patient Registry (HEALTH)

June 20, 2022 updated by: Coram Clinical Trials

Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home (HEALTH)

The HEALTH Registry is a prospective, observational, non-interventional registry study of patients receiving home parenteral nutrition therapy in the US for a variety of indications.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The objective of the HEALTH Patient Registry is to establish and track therapy utilization and outcomes of patients receiving home parenteral nutrition therapy. Data collected will include information on patient safety, clinical outcomes, resource utilization and health-related quality of life (QOL). The goals of this Registry include:

  • To better understand the patients and populations requiring HPN in the U.S.
  • To measure clinical outcomes associated with HPN
  • To identify areas for focused quality improvement interventions
  • To provide opportunity for resource allocation identification and improvement

Study Type

Observational

Enrollment (Anticipated)

1700

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

  • United States
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Coram CVS Specialty Infusion Services

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The HEALTH Registry program will collect data representative of patients receiving total parenteral nutrition (TPN) in the homecare setting.

Description

Inclusion Criteria:

  • Patient of any age, gender, and indication referred to Coram/CVS Specialty Infusion Services to receive HPN in an alternate site of care, such as the home or infusion suite
  • Patient must be managed by Coram/CVS Specialty Infusion Services
  • The patient or the patient's caregiver must be willing to receive care and comply with the teaching and training necessary to administer treatment

Exclusion Criteria:

  • Patient is unable to start, or stops receiving HPN
  • Patient is NOT managed by Coram/CVS Specialty Infusion Services
  • A patient and/or a patient's insurance will not cover cost of HPN therapy with Coram/CVS, or a patient elects not to start treatment

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

Cohorts and Interventions

Group / Cohort
patients receiving home parenteral nutrition
Includes patients receiving home parenteral nutrition for any indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life over time: The Short Form (36)
Time Frame: At baseline and every 6 months during therapy through study completion, up to 3 years
To examine the effect of HPN support on quality of life (functional health and well-being) as measured by The Short Form (36) Health Survey (SF-36v2). Physical component summary (PCS) and mental component summary (MCS) scores on a scale of 0 to 100 with higher scores reflecting better outcomes will be utilized.
At baseline and every 6 months during therapy through study completion, up to 3 years
Efficacy of Home Parenteral Nutrition defined as the percentage of patients reaching their PN therapy goals
Time Frame: through study completion, an average of 3 years
The therapy goals (i.e. weight gain, weight loss, weight maintenance, resolution of GI issue, etc). will be recorded at study start. Percentage of patients reaching their designated therapy goal will be recorded (presented as a single percentage of patients that successful reached any therapy goal)
through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter-related infections
Time Frame: through study completion, an average of 3 years
Determine rate of catheter-related blood stream infections (CRBSIs) ( per 1000 catheter days)
through study completion, an average of 3 years
Number of hospital readmissions and ER visits
Time Frame: through study completion, an average of 3 years
Assess number of hospital readmissions and visits to the ER
through study completion, an average of 3 years
Mortality rate
Time Frame: through study completion, an average of 3 years
Number of study participants who expired during therapy
through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coram Clinical Trials

Investigators

  • Principal Investigator: Mark DeLegge, MD, Coram

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)

June 17, 2019

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

July 9, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 29, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-10-06

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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