MalnutritionHEALTHNCT04035551
Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home Patient Registry
An observational study of Malnutrition and Patients Requiring Home Parenteral Nutrition, run by Coram Clinical Trials at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malnutrition, Patients Requiring Home Parenteral Nutrition
- How many people
- 1,700 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 1 Jul 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The HEALTH Registry program will collect data representative of patients receiving total parenteral nutrition (TPN) in the homecare setting.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Coram CVS Specialty Infusion Services
Centennial, Colorado, 80112
About this study
Official title: Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home (HEALTH)
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.
Read the 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
- Keywords
- Home, HPN, Homecare
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients receiving home parenteral nutrition | Includes patients receiving home parenteral nutrition for any indication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: through study completion, an average of 3 years
Secondary outcomes (3)
Catheter-related infections
Determine rate of catheter-related blood stream infections (CRBSIs) ( per 1000 catheter days)
Measured: 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
Measured: through study completion, an average of 3 years
Mortality rate
Number of study participants who expired during therapy
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start17 Jun 2019
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,700 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Coram Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark DeLegge, MD, Principal investigator, Coram
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035551
- Sponsor's protocol ID
- CT-10-06
- Acronym
- HEALTH
- Status last verified
- Mar 2022
- First submitted
- 9 Jul 2019
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home (HEALTH)
- ClinicalTrials.gov ID
- NCT04035551
- Acronym / sponsor ID
- HEALTH / CT-10-06
- Keywords
- Home, HPN, Homecare
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Coram Clinical TrialsUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients receiving home parenteral nutrition | – | –Includes patients receiving home parenteral nutrition for any indication. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The HEALTH Registry program will collect data representative of patients receiving total parenteral nutrition (TPN) in the homecare setting.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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)
3 secondary outcomes
Catheter-related infections
Time frame: through study completion, an average of 3 years
Number of hospital readmissions and ER visits
Time frame: through study completion, an average of 3 years
Mortality rate
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark DeLegge, MD principal investigator
Coram
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Patients Requiring Home Parenteral Nutrition, run by Coram Clinical Trials at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.