An observational study in Malnutrition and Patients Requiring Home Parenteral Nutrition, sponsored by Coram Clinical Trials. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Coram Clinical Trials · Observational
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.
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:
1,619 studies on the registry are indexed under Malnutrition; 241 are open to participants now.
This study's planned enrollment of 1,700 is above the median of 206 across 401 observational studies indexed under Malnutrition.
Browse Malnutrition studies →Coram Clinical Trials is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The HEALTH Registry program will collect data representative of patients receiving total parenteral nutrition (TPN) in the homecare setting.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Includes patients receiving home parenteral nutrition for any indication.
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.
Time frame: 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)
Time frame: through study completion, an average of 3 years
Catheter-related infections
Determine rate of catheter-related blood stream infections (CRBSIs) ( per 1000 catheter days)
Time frame: through study completion, an average of 3 years
Number of hospital readmissions and ER visits
Assess number of hospital readmissions and visits to the ER
Time frame: through study completion, an average of 3 years
Mortality rate
Number of study participants who expired during therapy
Time frame: through study completion, an average of 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Coram Clinical Trials