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

Malnutrition Clinical Trial

— HEALTH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04035551
• Other study ID #: CT-10-06
• Status: Active, not recruiting
• Start date: June 17, 2019
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2022
• Source: Coram Clinical Trials
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1700
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Patients Requiring Home Parenteral Nutrition

Locations

Country	Name	City	State
United States	Coram CVS Specialty Infusion Services	Centennial	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Coram Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

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