Longitudinal Evaluation of the Impact of Parenteral Nutrition

Parenteral Nutrition Clinical Trial

Official title:

Longitudinal Evaluation of Patient Outcomes and Impact Assessment on Family Members of Home Parenteral Nutrition: New Directions for Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234490
• Other study ID #: Longitudinal PNIQ
• Status: Completed
• Start date: March 2, 2020
• Est. completion date: March 23, 2022

Study information

• Verified date: May 2022
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 912
• Est. completion date: March 23, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parenteral Nutrition

Intervention

Procedure:
• Parenteral nutrition
Impact of parenteral nutrition on patient quality of life over time and impact on carer burden

Locations

Country	Name	City	State
United Kingdom	University of Manchester	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	Shire International GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, five, 10 and 15 months post entry
Secondary	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	Baseline
Secondary	Length of time receiving HPN	Amount of time the patient has been receiving HPN (months/years)	Baseline, five, 10 and 15 months post entry
Secondary	Change in number of weekly HPN infusions	How often the patient is connected to an infusion each week (numerical)	Baseline, five, 10 and 15 months post entry
Secondary	Change in number of hours connected to HPN infusions each night	How many hours the patient is connected to an infusion each night (hours)	Baseline, five, 10 and 15 months post entry

External Links

•   Institute research project page