Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home Patient Registry (NCT04035551) | Clinical Trial Compass
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Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home Patient Registry
United States1,700 participantsStarted 2019-06-17
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Quality of Life over time: The Short Form (36)
Timeframe: At baseline and every 6 months during therapy through study completion, up to 3 years
2
Efficacy of Home Parenteral Nutrition defined as the percentage of patients reaching their PN therapy goals
Timeframe: through study completion, an average of 3 years