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Trial record 11 of 68 for:    tpn

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

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ClinicalTrials.gov Identifier: NCT04035551
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Coram Clinical Trials

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.

Condition or disease
Malnutrition Patients Requiring Home Parenteral Nutrition

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1700 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home (HEALTH)
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.

  2. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Mortality rate [ Time Frame: through study completion, an average of 3 years ]
    Number of study participants who expired during therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035551


Contacts
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Contact: Allyson Checkley, PhD 303-916-7060 allyson.checkley@coramhc.com
Contact: Loretta Kristofek, RN, BSN 321-206-3969 loretta.kristofek@coramhc.com

Locations
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United States, Colorado
Coram CVS Specialty Infusion Services Recruiting
Centennial, Colorado, United States, 80112
Contact: Allyson Checkley, PhD    303-916-7060    allyson.checkley@coramhc.com   
Contact: Loretta Kristofek, RN, BSN    321-206-3969    loretta.kristofek@coramhc.com   
Sponsors and Collaborators
Coram Clinical Trials
Investigators
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Principal Investigator: Mark DeLegge, MD Coram

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Responsible Party: Coram Clinical Trials
ClinicalTrials.gov Identifier: NCT04035551     History of Changes
Other Study ID Numbers: CT-10-06
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Coram Clinical Trials:
Home
HPN
Homecare
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders