Parenteral NutritionNCT04234490
Longitudinal Evaluation of the Impact of Parenteral Nutrition
An observational study of Parenteral Nutrition, run by University of Manchester at 1 site in United Kingdom.
Trial summary
Patients with type 3 intestinal failure are completely reliant on artificial feeding and often manage this at home; home parenteral nutrition (HPN). HPN therapy is life saving for these patients. The Parenteral Nutrition Impact Questionnaire (PNIQ) is a proven tool for measuring quality of life when receiving HPN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenteral Nutrition
- What is being tested?
- Parenteral nutrition
- Type of treatment
- Surgery or procedure
- How many people
- 912 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2020to 23 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 1400 eligible participants from at least 15 NHS sites who are receiving HPN will be invited to participate. Close family relatives or friends who are carers for the eligible participants will also be invited to participate.
Who may be able to join
- Patients:
- All people in receipt of HPN including new patients
- Those 18 years and over.
- Carers:
- A family member or person involved in the healthcare of the participating patient. (We will ask patients to nominate their closest family member who in their opinion is potentially most effected by the parenteral feeding.)
- Those 18 years and over.
Who cannot join
- Patients:
- Cannot give informed consent
- Cannot read or write in English.
- Carers:
- Family members not directly involved with caring for participants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Evaluation of Patient Outcomes and Impact Assessment on Family Members of Home Parenteral Nutrition: New Directions for Research
Patients with type 3 intestinal failure are completely reliant on artificial feeding and often manage this at home; home parenteral nutrition (HPN). HPN therapy is life saving for these patients.
The Parenteral Nutrition Impact Questionnaire (PNIQ) is a proven tool for measuring quality of life when receiving HPN.
This study will recruit HPN patients across the United Kingdom (UK) and ask them to complete the PNIQ survey at several different time points. This will assess the impact of HPN over time. Family members involved in the participants HPN care will also be asked to complete a carer burden survey (at one time point) to assess the impact of HPN on carers.
Read the detailed description
Providing a person with food through a vein is known as parenteral nutrition (PN) or artificial tube feeding. This process is used when nutrients from food can't be taken in by the intestine (intestinal failure). Patients with type 3 intestinal failure are completely reliant on artificial feeding and often manage this at home; home parenteral nutrition (HPN). HPN therapy is life saving for these patients.
It is important to assess patients quality of life and their own reported effects of the HPN. The Parenteral Nutrition Impact Questionnaire (PNIQ) is a proven tool for measuring quality of life when receiving HPN.
A recent study involving the use of the PNIQ in multiple hospitals in the UK, showed that those on fewer nights of HPN had better quality of life than those on more nights of HPN. Whilst this was useful for looking at quality of life at one time point, it is now important to assess change in quality life over time and any impact on family members quality of life.
This study will recruit HPN patients across the UK and ask them to complete the PNIQ survey at several different time points. This will assess the impact of HPN over time. Family members involved in the participants HPN care will also be asked to complete a carer burden survey (at one time point) to assess the impact of HPN on carers.
The study is being funded by Shire Pharmaceuticals Ltd.
- Conditions
- Parenteral Nutrition
- Being tested
- Parenteral nutrition
- Keywords
- Intestinal failure, Quality of life, Carer burden
- Medical subject headings
- Hyperphagia, Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral nutritionProcedure or surgery
Also called Home parenteral nutrition, artificial tube feeding
Impact of parenteral nutrition on patient quality of life over time and impact on carer burden
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients who are receiving Home Parenteral Support (HPN) (artificially fed through a vein) due to intestinal failure Receives: Procedure: Parenteral nutrition | |
| Carer | Family member or carer of patient who is receiving Home Parenteral Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcomes
Change in Patient reported outcomes (PNIQ score) in people receiving HPN. Score from 0-20, with 0 being high Quality of life and 20 being low quality of life.
Measured: Baseline, five, 10 and 15 months post entry
Secondary outcomes (4)
Carer burden
Caregiver burden (carer burden survey) in family members/close friends providing HPN healthcare to a patient receiving HPN. Score from 0-84, with 0 being no symptoms and 84 being very severe symptoms
Measured: Baseline
Length of time receiving HPN
Amount of time the patient has been receiving HPN (months/years)
Measured: Baseline, five, 10 and 15 months post entry
Change in number of weekly HPN infusions
How often the patient is connected to an infusion each week (numerical)
Measured: Baseline, five, 10 and 15 months post entry
Change in number of hours connected to HPN infusions each night
How many hours the patient is connected to an infusion each night (hours)
Measured: Baseline, five, 10 and 15 months post entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start2 Mar 2020
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenteral NutritionStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 912 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Shire International GmbH
- Responsible party
- Principal investigator, Debra Jones, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234490
- Sponsor's protocol ID
- Longitudinal PNIQ
- Status last verified
- May 2022
- First submitted
- 13 Jan 2020
- Last updated
- 24 May 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 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Patient Outcomes and Impact Assessment on Family Members of Home Parenteral Nutrition: New Directions for Research
- ClinicalTrials.gov ID
- NCT04234490
- Acronym / sponsor ID
- Longitudinal PNIQ
- Conditions
- Parenteral Nutrition
- Keywords
- Intestinal failure, Quality of life, Carer burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 912 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Shire International GmbH
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 21 Jan 2020 (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.
Patients with type 3 intestinal failure are completely reliant on artificial feeding and often manage this at home; home parenteral nutrition (HPN). HPN therapy is life saving for these patients.
The Parenteral Nutrition Impact Questionnaire (PNIQ) is a proven tool for measuring quality of life when receiving HPN.
This study will recruit HPN patients across the United Kingdom (UK) and ask them to complete the PNIQ survey at several different time points. This will assess the impact of HPN over time. Family members involved in the participants HPN care will also be asked to complete a carer burden survey (at one time point) to assess the impact of HPN on carers.
Detailed description
Providing a person with food through a vein is known as parenteral nutrition (PN) or artificial tube feeding. This process is used when nutrients from food can't be taken in by the intestine (intestinal failure). Patients with type 3 intestinal failure are completely reliant on artificial feeding and often manage this at home; home parenteral nutrition (HPN). HPN therapy is life saving for these patients.
It is important to assess patients quality of life and their own reported effects of the HPN. The Parenteral Nutrition Impact Questionnaire (PNIQ) is a proven tool for measuring quality of life when receiving HPN.
A recent study involving the use of the PNIQ in multiple hospitals in the UK, showed that those on fewer nights of HPN had better quality of life than those on more nights of HPN. Whilst this was useful for looking at quality of life at one time point, it is now important to assess change in quality life over time and any impact on family members quality of life.
This study will recruit HPN patients across the UK and ask them to complete the PNIQ survey at several different time points. This will assess the impact of HPN over time. Family members involved in the participants HPN care will also be asked to complete a carer burden survey (at one time point) to assess the impact of HPN on carers.
The study is being funded by Shire Pharmaceuticals Ltd.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Procedure: Parenteral nutritionPatients who are receiving Home Parenteral Support (HPN) (artificially fed through a vein) due to intestinal failure |
| Carer | – | –Family member or carer of patient who is receiving Home Parenteral Support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 1400 eligible participants from at least 15 NHS sites who are receiving HPN will be invited to participate. Close family relatives or friends who are carers for the eligible participants will also be invited to participate.
Key inclusion criteria (6 listed)
- All people in receipt of HPN including new patients
- Those 18 years and over.
- A family member or person involved in the healthcare of the participating patient. (We will ask patients to nominate their closest family member who in their opinion is potentially most effected by the parenteral feeding.)
- Those 18 years and over.
Key exclusion criteria (5 listed)
- Cannot give informed consent
- Cannot read or write in English.
- Family members not directly involved with caring for participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenteral nutritionAlso: Home parenteral nutrition, artificial tube feedingImpact of parenteral nutrition on patient quality of life over time and impact on carer burden | Procedure or surgery | Patient |
Primary outcome
Patient reported outcomes
Time frame: Baseline, five, 10 and 15 months post entry
Change in Patient reported outcomes (PNIQ score) in people receiving HPN. Score from 0-20, with 0 being high Quality of life and 20 being low quality of life.
4 secondary outcomes
Carer burden
Time frame: Baseline
Length of time receiving HPN
Time frame: Baseline, five, 10 and 15 months post entry
Change in number of weekly HPN infusions
Time frame: Baseline, five, 10 and 15 months post entry
Change in number of hours connected to HPN infusions each night
Time frame: Baseline, five, 10 and 15 months post entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Institute research project pageLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Parenteral Nutrition, run by University of Manchester at 1 site in United Kingdom.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 24 May 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient reported outcomes (time frame: Baseline, five, 10 and 15 months post entry). 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 24 May 2022.