Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04234490
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2020-01-13
Brief Title:
Longitudinal Evaluation of the Impact of Parenteral Nutrition
Sponsor:
University of Manchester
Organization:
University of Manchester
Study Overview
Official Title:
Longitudinal Evaluation of Patient Outcomes and Impact Assessment on Family Members of Home Parenteral Nutrition New Directions for Research
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 cant 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None