Longitudinal Evaluation of the Impact of Parenteral Nutrition
NCT ID: NCT04234490
Last Updated: 2022-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
912 participants
OBSERVATIONAL
2020-03-02
2022-03-23
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient
Patients who are receiving Home Parenteral Support (HPN) (artificially fed through a vein) due to intestinal failure
Parenteral nutrition
Impact of parenteral nutrition on patient quality of life over time and impact on carer burden
Carer
Family member or carer of patient who is receiving Home Parenteral Support
No interventions assigned to this group
Interventions
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Parenteral nutrition
Impact of parenteral nutrition on patient quality of life over time and impact on carer burden
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Cannot give informed consent
* Cannot read or write in English.
Carers:
• Family members not directly involved with caring for participants
18 Years
ALL
No
Sponsors
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Shire International GmbH
UNKNOWN
University of Manchester
OTHER
Responsible Party
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Debra Jones
Nutrition Research Associate
Locations
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University of Manchester
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Other Identifiers
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Longitudinal PNIQ
Identifier Type: -
Identifier Source: org_study_id
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