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

NCT04035551 | Unknown

• 1 other identifier: CT-10-06
• Study Type: observational
• Target: 1,700
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malnutrition; Patients Requiring Home Parenteral Nutrition

Keywords

Home; HPN; Homecare

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Life over time: The Short Form (36)

  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

  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 Outcomes (3)

• Catheter-related infections

  through study completion, an average of 3 years

• Number of hospital readmissions and ER visits

  through study completion, an average of 3 years

• Mortality rate

  through study completion, an average of 3 years

Study Arms (1)

patients receiving home parenteral nutrition

Includes patients receiving home parenteral nutrition for any indication.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coram Clinical Trials: lead

Study Sites (1)

Coram CVS Specialty Infusion Services

Centennial, Colorado, 80112, United States

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Mark DeLegge, MD

  Coram

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 29, 2019
• Study Start: June 17, 2019
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: June 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)