Longitudinal Evaluation of the Impact of Parenteral Nutrition

Completed

• Conditions: Parenteral Nutrition
• Interventions: Procedure: Parenteral nutrition

• Registration Number: NCT04234490
• Lead Sponsor: University of Manchester

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.

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 Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-21
• Study Start: 2020-03-02
• Primary Completion: 2022-03-23
• Study Completion: 2022-03-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 912

Inclusion Criteria

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.

Exclusion Criteria

Patients:

• Cannot give informed consent
• Cannot read or write in English.

Carers:

• Family members not directly involved with caring for participants

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient	Parenteral nutrition	Patients who are receiving Home Parenteral Support (HPN) (artificially fed through a vein) due to intestinal failure

Primary Outcome Measures

Name	Time	Method
Patient reported outcomes	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.

Secondary Outcome Measures

Name	Time	Method
Length of time receiving HPN	Baseline, five, 10 and 15 months post entry	Amount of time the patient has been receiving HPN (months/years)
Change in number of weekly HPN infusions	Baseline, five, 10 and 15 months post entry	How often the patient is connected to an infusion each week (numerical)
Carer burden	Baseline	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
Change in number of hours connected to HPN infusions each night	Baseline, five, 10 and 15 months post entry	How many hours the patient is connected to an infusion each night (hours)

Trial Locations

Locations (1)

University of Manchester; 🇬🇧 Manchester, United Kingdom